Clinical trial NCT05781490
Conditions: Healthy
Sponsor: Lument AB
Start date: 2023-01-15; Completion date: 2023-02-28
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A healthy volunteer, open, PoC single center trial investigating a new oral contrast agent for use in combination of MR examination of the abdomen and pelvis.

The main purpose of the trial is to evaluate if Lumentin® 44 used as a bowel filling agent in MRE examination generates images with acceptable diagnostic quality.

In addition, the plasma electrolytes concentration levels, including, potassium, sodium, phosphate, and calcium, as well as ionized calcium will be evaluated over a 24 hour time period after intake of Lumentin.

Detailed description:
This is an uncontrolled, single centre phase II trial. Enrolled HVs (n=10) will undergo Gd-enhanced MRE after oral intake of Lumentin® 44.

Interested HVs will be identified primarily among medical students at the medical hospitals at Malmö and Lund. Posters will be placed at the departments and invitation letters will be handed out.

The HVs interested in participating will be invited to attend a pre-screening visit where their suitability based on age and health status will be assessed. Fifteen HVs who fulfil the pre-screening criteria and are interested in participating will be asked to attend a screening visit at the clinic and if eligible for the trial they will then visit the clinic for the MRE assessment within 1-2 weeks.

Only the initial 10 of the eligible HVs will be asked to come for the MRE examination and the remaining eligible subjects will be asked to stand by in case any of the 10 subjects are unable to come or cannot undergo the examination.

HVs will be asked to fast for 6 hours prior to the examination on the day of the MRE examination. Small amount of clear liquid is allowed up to 2 decilitres. Prior to MRE, Lumentin® 44 will be provided to them in volumes of up to 1,500 mL and at least 1,100 mL of Lumentin® 44 must be drunk. The subjects will be asked to drink the solutions of oral contrast agent within 45 minutes to 1 hour.

Subjects not able to drink at least 1.1 L of Lumentin® 44 will be withdrawn from the trial.

Prior to the intake of Lumentin® 44, an IV antecubital cannula will be placed and used for blood sampling and administration of gadolinium (Gd) contrast agent during the MRE assessment.

Arms: arm 1: Lumentin® 44 Powder for oral foam
Interventions: intervention 1: Lumentin® 44 Powder for oral foam
Intervention descriptions: intervention 1: Lumentin® 44 is a foam for oral use.

Protocol documents:
Prot_SAP_000.pdf: 
    
 
 
 
C LI NI C A L T RI A L P R O T O C O L 
 
A n u nc o ntr olle d, si n gle ce ntre, healt h y v ol u nteer, P hase II pr o of- of-c o n ce pt tri al i n vesti gati n g 
M R-e nter o gra p h y i ma ge q u alit y of L u me nti n
®  4 4, a ne w e g g al b u me n base d oral s mall b o wel 
filli n g c o ntrast a g e nt. 
 
S p o ns or si g nat or y: 
Ja n Marsal 
L u me nt A B 
S c heele v ä g e n 2 2 
B o x 7 1 9 
S E- 2 2 0 0 7 L u n d 
S we de n 
 
C o or di n ati n g I n vesti gat or 
Dr. Pet er Le a n der 
R ö nt g e n, Perit us kli ni ke n A B 
S c heele v ä g e n 8 
2 2 3 6 3 L u n d 
S we de n 
 
S p o ns or Pr ot oc ol N o.:  
L U M RI S -0 0 1  
Pr ot o c ol Versi o n  
2 . 0 Fi nal 
E u dra C T N o.: 
2 0 2 2- 0 0 2 1 9 3- 8 4 
Trial  Dr u g Na me:  
L u me nti n ®  4 4  
De vel o p me nt P hase:  
II 
Date of Pr ot oc ol:  
0 9 t h Se pt e m ber  2 0 2 2  
Date of Pre vi o us Pr ot oc ol:  
0 9 t h Se pt e m ber 2 0 2 2  
 
T his d oc u me nt c o nt ai ns c o nfi de ntial i nf or mati o n. T he c o nte nts ma y n ot b e use d, di v ul g e d or 
p u blis he d wit h o ut pri or writte n c o nse nt of L u me nt A B.  
T his i nf or mati o n ca n n ot be use d f or a n y ot her p ur p ose t ha n t he c o n d uct a n d e val uati o n of t he 
cli nical i n vesti gati o n b y t he i n v esti g at or(s), t he re g ulat or y a ut h orities a n d m e m b ers of t h e et hics 
c o m mittees


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1  
P R O T O C O L S Y N O P S I S 
 
Title: 
A n u nc o ntr olle d, si n gle c e ntre, healt h y v ol u nteer, P hase II pr o of- of-c o nce pt 
trial i n vesti gati n g M R-e nter o gra p h y ( M R E) i m a ge q u alit y of L u me nti n®  4 4, 
a n e w e g g al b u me n base d oral s mall b o wel filli n g c o ntrast a ge nt. 
S h ort titl e: 
L u me nti n M R-e nt er o gra p h y P o C trial i n h ealt h y v ol u nt eers 
E u dr a C T 
C o de: 
2 0 2 2- 0 0 2 1 9 3- 8 4 
P h ase of 
d e vel o p m e nt 
P h ase II 
B ac k gr o u n d & 
st u d y r ati o n ale  
L u me nti n ®  4 4 is bei n g d e vel o p e d as a n o v el oral c o ntrast me di u m t o b e us e d 
i n dia g n ostic e xa mi nati o ns of t he a b d o me n. P hase II st u dies ha ve bee n 
perf or me d usi n g c o m p ut e d t o m o gra p h y ( C T) ass ess me nt wit h e nc o ura gi n g 
res ults. If t he sa me pr o d u ct ca n als o b e us e d i n M a g netic Res o na nce-
e nt er o gra p h y ( M R E) it c o ul d be a n a d v a nt a ge f or a ra di ol o gical de part m e nt 
t o o nl y ha n dle a si n gle oral c o ntrast me di u m f or b ot h m o d aliti es, C T a n d 
M RI. I n a d diti o n, a d mi nistrati o n of L u me nti n
®  4 4 has s h o w n fe w si de effects 
a n d ma y be a m ore t olera bl e alter nati v e t o t he oral me dia use d t o da y i n C T 
a n d M RI. T h e c urre nt st u d y ai ms t o e x pl ore if t h e si g nal c haracteristics of 
L u me nti n ®  4 4 is fa v o ura ble i n M R E. 
T his pr o of- of-c o nce pt ( P o C) trial is perf or me d i n healt h y v ol u nteers ( H Vs) 
wit h t he ai m t o s h o w t h at L u me nti n ®  4 4 ca n be use d as a n oral s mall b o wel 
filli n g c o ntrast a g e nt f or M R E.  
Pri m a r y 
o bjecti ve 
 T o e val uate if L u m e nti n ®  4 4 use d as a b o w el filli n g a ge nt i n M R E 
e xa mi nati o n ge n erates i ma ges wit h acce pta bl e di a g n ostic q ualit y. 
S ec o n d ar y 
o bjecti ves 
 
 
 
 
 
 
 T o e val uate pl as m a el ectr ol ytes i ncl u di n g, p otassi u m, s o di u m, p h os p hate, 
a n d calci u m, as w ell as i o nize d calci u m c o nce ntrati o n le vels d uri n g 2 4 
h o urs after i nta ke of L u m e nti n ®  4 4. 
 T o e val uate b o w el filli n g pr o perties (e xte nsi o n a n d diste nsi o n) of 
L u me nti n ®  4 4. 
 T o e val uate t he s afet y a n d t olera bilit y of L u me nti n ®  4 4 i nta ke. 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
3 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
 
 
Pri m a r y 
o utc o me 
 
 
 
 Vis u al e val uati o n of t he M R E i ma ges fr o m eac h trial s u bject wit h res pect 
t o m otilit y, artefacts, m u c osal e val uati o n a n d o verall dia g n ostic 
i m pressi o n. 
S ec o n d ar y 
o utc o mes 
 C o nce ntrati o n of plas ma electr ol ytes i n cl u di n g, p otassi u m, s o di u m, 
p h os p h ate, a n d calci u m, as well as i o nize d calci u m i n bl o o d sa m ples 
ta ke n at T 0 h, T 1 h, T 2 h, T 4 h, T 6 h, T 8 h, a n d T 2 4 h. 
 B o wel filli n g pr o perti es (e xt e nsi o n a n d dist e nsi o n) i n eac h of 5 s electe d 
s u b-se g me nts of t he s mall b o wel. 
 A n y treat me nt e mer ge nt a d verse e ve nts ( T E A Es) a n d treat me nt e m er g e nt 
a d verse dr u g reacti o ns ( T E A D Rs). 
I n vesti g ati o n al 
p r o d uct, 
f or m ul ati o n, 
d os a g e a n d 
m o de of 
a d mi nistr ati o n:  
L u me nti n ®  4 4 P o w der f or oral f oa m pr o vi de d i n la belle d w hite sa c hets w hite 
sac hets c o ntai ni n g 1 7. 4 g p o w der. P ota ble w ater (c o m merciall y a v aila ble still 
water 0. 5 L p er b ottle) f or t he pre p arati o n of t h e f oa m will b e use d. 
L u me nti n ® 4 4 p o w der f or oral f oa m will b e d eli vere d fr o m A P L t o t h e 
cli nical site, b y or der vi a t he h os pital p har mac y a n d st ore d te m p oraril y at t h e 
site. T he i n vesti gati o nal pr o d uct ( L u me nti n ® 4 4 f oa m) is t he n pre p are d i n-
sit u b y a d di n g 0. 5 L p ota ble water t o L u me nti n ®  4 4 p o w der c o nt ai n e d i n o ne 
sac het, a n d t he ble n d is t he n mi xe d t o a sta ble f o a m i n a de dicate d 
pre parati o n u nit. T h e fres hl y pre pare d f oa m will be a d mi nistere d t o t he 
patie nt wit hi n 5 t o 1 0 mi n utes. T he i n-sit u pre p arati o n will f oll o w 
a pr oce d ure attac he d t o t he cli nical tri al pr ot oc ol. T he staff res p o nsi ble f or 
t he i n-sit u pre p arati o n will be trai ne d usi n g t h e pr o ce d ure a n d t heir trai ni n g 
d oc u me nte d i n t he Trial Master Fil e.  T w o sac h ets ( 0. 9 L f oa m per sac het) 
will be re q uire d p er s u bject.  
Tri al desi g n 
T his is a n u n c o ntr olle d, si n gle ce ntre p h ase II trial. E nr olle d H Vs ( n = 1 0) will 
u n der g o ga d oli ni u m ( G d) b ase d M R E after oral i nt a k e of L u me nti n ®  4 4. 
I ntereste d H Vs will be i d e ntifie d pri maril y a m o n g me dical st u d e nts at t h e 
me di cal h os pitals at Mal m ö a n d L u n d. P ost ers will b e pl ace d at t he 
de p art me nts a n d i n vit ati o n letters will be ha n de d o ut. 
H Vs i ntereste d i n parti ci pati n g will be i n vite d t o atte n d a pre-scree ni n g visit 
w here t heir s uita bilit y base d o n a ge a n d healt h stat us will b e assess e d. Fift ee n 
H Vs w h o f ulfil t h e pre-scree ni n g criteri a a n d are still i ntereste d i n 
partici p ati n g will be as ke d t o att e n d a s cree ni n g visit at t he cli nic a n d if 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
4 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
eli gi ble f or t he trial t he y will t he n visit t h e cli nic f or M R E assess me nt wit hi n 
1- 2 wee ks.   
O nl y t he first 1 0 of t he eli gi ble H Vs will be as k e d t o c o me f or M R E 
e xa mi nati o n a n d t he re m ai ni n g eli gi ble s u bjects will b e as k e d t o sta n d b y i n 
case a n y of t h e 1 0 s u bjects are u n a ble t o c o me or ca n n ot u n der g o t h e 
e xa mi nati o n.  
H Vs will be as ke d t o fast f or 6 h o urs pri or t o t he e xa mi n ati o n o n t he da y of 
t he M R E e xa mi nati o n. Clear li q ui d i n s mall v ol u mes u p t o 2 decilitres is 
all o we d. Pri or t o M R E, L u me nti n ®  4 4 will be pr o vi de d t o t he m i n v ol u mes of 
u p t o 1. 5 L a n d at l east 1. 1 L of L u me nti n ®  4 4 m ust b e dr u n k. T he s u bjects 
will be as ke d t o dri n k t h e s ol uti o ns of oral c o ntrast a ge nt wit hi n 4 5 mi n ut es 
t o 1 h o ur.  
S u bjects n ot a ble t o dri n k at l east 1. 1 L of L u me nti n ®  4 4 will be wit h dra w n 
fr o m t h e tri al. 
Pri or t o t h e i nta ke of L u me nti n ®  4 4, a n i ntra ve n o us (I V) a nt ec u bital c a n n ul a 
will be place d a n d us e d f or bl o o d sa m pli n g a n d a d mi nistrati o n of G d c o ntrast 
a ge nt d uri n g t h e M R E assess me nt.  
Assess me nts  
Scree ni n g assess me nts: H Vs f ulfilli n g t he eli gi bilit y crit eria a n d w h o si g n 
t he c o nse nt t o p artici pate will u n d er g o a p h ysical e xa mi nati o n, p erf or m a 
pre g n a nc y test (fe m al es o nl y) a n d ha ve a creati ni ne bl o o d sa m ple ta ke n. 
Me dical hist or y, de m o gr a p hics, c o nc o mita nt treat me nt a n d ill n esses will als o 
be rec or de d.. 
M R E assess me nt:  M R E will start wit hi n 1 0 mi n utes aft er t he c o ntrast a ge nt 
has bee n dr u n k a n d will last f or a p pr o xi mat el y 4 0 mi n utes. 
T he H V will be br o u g ht t o t he M R E-sca n n er s uit e i nsi d e t h e m a g net usi n g 
t he m o vi n g ta ble a n d sca n ni n g will c o m me nce. All series will b e ta ke n as per 
sta n dar d cli nical M R E pr ot o c ol rec o g nise d b y ra di ol o gists i n E ur o pe a n d 
N ort h A meric a. After d y na mic series ac q uisiti o n, a s pas m ol ytic a ge nt will b e 
gi ve n a n d 3 D gra die nt-ec h o seri es will b e ta ke n a n d will b e re peate d 4 0 
sec o n ds t hereaft er, f oll o wi n g I V a d mi nistrati o n of G d c o ntrast a g e nt at a d ose 
of 0. 1 m m ol/ k g per b o d y wei g ht. S u bse q ue ntl y, t he re m ai ni n g series will be 
ta ke n acc or di n g t o pr ot o c ol. 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
5 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
Electr ol yte ass ess me nt:  A bl o o d ( baseli ne) s a m ple f or electr ol yte a n al ysis 
will be c ollect e d j ust pri or t o t he H V starti n g t o dri n k L u me nti n ®  4 4.  A 
sec o n d bl o o d s a m ples will be c ollect e d o ne h o ur after t he bas eli ne bl o o d 
sa m ple. N o m ore L u me nti n ®  4 4 ca n be dr u n k after t his bl o o d sa m pl e has 
bee n c olle cte d. A d diti o n al bl o o d sa m ples will be c ollecte d at 2, 4, 6, 8, a n d 
2 4 h o urs p ost baseli ne sa m ples.  
S afet y ass ess m e nt:  T h e occ urre nce of a d v erse e v e nts a n d c o nc o mita nt 
treat me nt will be re c or de d f or t he d urati o n of t h e tri al.  
F or safet y reas o ns, s u bj ects will b e c o ntacte d wit hi n 2 t o 4 da ys after t he 
M R E e xa mi nati o n b y t he i n vesti gat or a n d as k e d a b o ut occ urre nce of a n y 
a d verse e ve nt. N o ot h er f oll o w- u p is pla n ne d. 
Tri al 
p o p ul ati o n 
H Vs f ulfilli n g t h e eli gi bilit y (i n-/e xcl usi o n) criteria.  
N u m ber of 
s u bjects 
A t otal of te n f ull y e val u a ble H Vs will be i n cl u de d i n t he trial. 
I n cl usi o n 
criteri a 
1.  Healt h y v ol u nteers of eit her ge n der at least 1 8 y ears at t h e ti me of si g ni n g 
t he i nf or me d c o nse nt.  
2.  Fe males m ust eit her pres e nt a n e gati v e pre g n a nc y test or be s ur gicall y 
steril e ( h ysterect o m y or t u bal li gati o n) or p ost me n o pa usal (i.e., 
e x perie n ce d 1 2 c o ns ec uti ve m o nt hs wit h o ut me nstr uati o n). 
3.  F oll o wi n g ver bal a n d writte n i nf or mati o n a b o ut t he trial, t h e s u bject m ust 
pr o vi d e si g ne d a n d dat e d i nf or me d c o nse nt bef ore a n y trial relat e d 
acti vit y is carrie d o ut. 
E xcl usi o n 
criteri a 
1.  Gl o mer ul ar Filtrati o n rate ( G F R) b el o w 6 0 ml/ mi n/ 1. 7 3 s q m b o d y 
s urface. All s u bjects will ha ve a plas ma creati ni ne ta ke n at scr ee ni n g f or 
cal c ulati o n of esti mate d G F R (e G F R). 
2.  Hist or y of dr u g relate d re acti o n t o ga d oli ni u m c o ntrast a ge nts. 
3.  Ha ve ha d g a d oli ni u m i njecti o n d uri n g t he last 4 w ee ks. 
4.  Cla ustr o p h o bi a n ot c o pi n g wit h M R E e xa mi nati o n. 
5.  Metal o bjects a n d me dical de vi ces i n t h e b o d y n ot j u d g e d b y t he 
i n vesti gat or t o be c o m pati ble wit h M R E. 
6.  H y perse nsiti vit y t o B us c o pa n ®  ( B ut yl h y osc o pi n). 
7.  Ha vi n g s wall o wi n g diffic ulties. 
8.  K n o w n all er g y t o e g g al b u me n.  


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
6 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
9.  K n o w n se nsiti vit y t o a n y of t he c o m p o ne nts of t h e i n vesti gati o nal 
pr o d uct. 
1 0.  Cli nical s us pici o n of o n g oi n g disease b y t he i n vesti gat or.  
1 1.  Bei n g, i n t he o pi ni o n of t he i n vesti gat or, u nli kel y t o c o m pl y wit h t he 
cli nical trial pr ot oc ol. 
1 2.  Pre vi o usl y i ncl u d e d i n t his trial. 
1 3.  Partici pati n g i n or h a vi n g p artici p ate d i n a n ot h er cli ni cal trial wit hi n t he 
last 4 w ee ks.  
St atistic al 
a n al yses 
All s u bjects w h o ha ve c o m plete d t he trial will b e i ncl u de d i n t he st atistical 
e val uati o n.  
N o statistical tests will be c o n d ucte d. C o nfi d e nce i nter vals ma y be 
c o nstr ucte d a n d will t he n be 2-si d e d a n d of 9 5 % c o nfi de nce.  
C o nti n u o us d at a will b e s u m marise d usi n g descri pti ve st atistics ( N, m ea n, 
me di a n, sta n d ar d d e viati o n, mi ni m u m a n d ma xi m u m). Cate g orical dat a will 
be s u m marise d b y fre q u e nc y t a bles ( n u m b ers a n d perce nta ges).  
U nless ot her wise state d, all a nal yses will be d o ne o n o bser ve d cases wit h o ut 
a n y s u bstit uti o n of missi n g val ues. 
 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
7 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
S c he d ule of Assess me nts  
Visit/ C o nt act 
1 
2 
3 
4 
5 
P re-scree ni n g  
S cree ni n g 
M R E e x a mi n ati o n 
Bl o o d 
s a m pli n g 
F- U  (1 ) a n d e arl y 
ter mi n ati o n 
D a y 
- 2 1 t o - 1 
0 
1 4 
1 5 
Visit 2 + 2 d a ys 
Visit wi n d o w ( d a ys) 
 
 
+/- 7 d a ys 
- 
+ 2 
S u bject i nf or mati o n 
X 
X 
 
 
 
I n/e x cl usi o n criteria 
( X)( 2) 
X 
 
 
 
I nf or me d c o ns e nt 
 
X 
 
 
 
P h ysical e xa mi n ati o n 
 
X 
 
 
 
Pre g na nc y test  ( 3) 
 
X 
 
 
 
Creati ni ne bl o o d s a m ple 
 
X 
 
 
 
S u bject de m o gra p hics  
(i ncl. hei g ht a n d wei g ht) 
 
X 
 
 
 
C o n c o mit a nt treat me nt 
X 
X 
X 
X 
X 
C o n c o mit a nt ill nesses 
X 
X 
 
 
 
Me di cal hist or y 
X 
X 
 
 
 
A d verse e ve nt(s) rec or di n g 
 
 
X  ( 4) 
X 
X 
Place me nt of I V a ntec u bital 
ca n n ula  
 
 
X  ( 5) 
 
 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
8 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
Visit/ C o nt act 
1 
2 
3 
4 
5 
P re-scree ni n g  
S cree ni n g 
M R E e x a mi n ati o n 
Bl o o d 
s a m pli n g 
F- U  (1 ) a n d e arl y 
ter mi n ati o n 
D a y 
- 2 1 t o - 1 
0 
1 4 
1 5 
Visit 2 + 2 d a ys 
Visit wi n d o w ( d a ys) 
 
 
+/- 7 d a ys 
- 
+ 2 
M R E Sca n 
 
 
X 
 
 
Dis pe nsi n g of L u me nti n ®  4 4  
 
 
X 
 
 
A d mi nistrati o n of G d c o ntrast 
( 6) 
 
 
X 
 
 
A d mi nistrati o n of B usc o pa n ® ( 6)  
 
 
X 
 
 
E val u ati o n of e xte nsi o n a n d 
diste nsi o n of b o wel filli n g 
a ge nts 
 
 
X 
 
 
Bl o o d sa m pli n g 
 
 
X  (5 ) 
( pre-, 1, 2, 4, 6, 8 h)  
X 
( 2 4 h) 
 
C o m plia nce 
 
 
X 
 
 
1)  S u bjects will b e c o ntacte d b y tele p h o n e t w o t o f o ur w or ki n g d a ys p ost M R E assess m e nt. 
2)  O nl y s o m e of t he criteria will b e c h ec k e d i n cl u di n g, i ncl usi o n crit eri o n 1 a n d e x cl usi o n criteri a 2, 3, 4, 5, 6, 7, 8, 1 2 a n d 1 3. 
3)  Uri n e pre g na nc y test of all fe males w h o are n ot s ur gicall y sterile ( h ysterect o m y or t u bal li g ati o n) or p ost m e n o pa usal (i.e., e x p erie n ce d 1 2 c o nsec uti v e 
m o nt hs wit h o ut me nstr uati o n). 
4)  T ele p h o n e i nter vie ws will b e c o n d u cte d 2 da ys after M R E ass ess m e nt t o i n v esti g ate if a n y A Es occ urr e d d uri n g t h e first da ys after t h e i ma gi n g pr oce d ure  
5)  A n I V a ntec u bit al ca n n ula will b e place d f or pre- bl o o d sa m pl es a n d use d d uri n g t h e first 8 h i n cl u di n g a d mi nistrati o n of ga d oli ni u m d uri n g t he M R E 
pr o ce d ure. T h ereaft er it will be discar de d. Bl o o d sa m pli n g o n t h e f oll o wi n g d a y ( 2 4 h ti me p oi nt) will be dra w n wit h o ut a ca n n ula. 
6)  Ga d oli ni u m ( G d) a n d B usc o pa n ® will o nl y b e a d mi nistere d as p art of t h e M R E e xa mi n ati o n. 
 
 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
9 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
2  
L I S T O F T R I A L P E R S O N N E L 
S p o ns or 
L u me nt A B 
S c heele vä g e n 2 2 
B o x 7 1 9 
S E- 2 2 0 0 7 L u n d 
S we de n 
P h o n e: + 4 6 7 0 8 7 6 1 0 6 5 
E- Mail: ol of. b o o k @l u me nta b.c o m  
 
Cli nical Pr oject Ma na ger  
J o ha n Q ue nsel, C E O 
P h o n e: + 4 6 7 6 0 4 6 9 7 4 4 
E- Mail: j q @ qcrc.se  
 
Res p o nsi ble M e dical Officer 
R d. Ja n Marsal, M D, P h D 
De part me nt of Gastr oe nt er ol o g y 
S ka ne U ni v ersit y H os pital 
S U S L u n d E A 1 2 
S E- 2 2 1 8 5 L u n d 
S we de n 
P h o n e: + 4 6 4 6 1 7 7 0 0 3 
M o bil e p h o ne: + 4 6 7 0 9 8 2 2 0 0 8 
E- mail: j a n. marsal @ me d.l u.se 
Pri nci pal i n vesti gat or  
Dr. Peter Lea n der, M D, P h D 
R ö nt ge n, Perit us kli ni ke n A B 
S c heele vä g e n 8 
S E- 2 2 3 6 3 L u n d 
S we de n 
P h o n e: + 4 6 4 6 2 8 8 6 0 3 0 
M o bil e p h o ne: + 4 6 7 6 8 8 7 1 0 6 9 
E- Mail: p eter.lea n der @ p erit us kli ni ke n.se 
 
 
 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 0 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
3  
T A B L E O F C O N T E N T S 
1  
Pr ot oc ol S y n o psis ...................................................................................................... 2  
Sc h e d ul e of Ass ess m e nts ............................................................................................................................ 7  
2  
List of Tri al Pers o n n el .............................................................................................. 9  
3  
T a ble of c o nte nts ..................................................................................................... 1 0  
4  
List of A b b re vi ati o ns a n d Defi niti o ns of Ter ms ................................................... 1 4  
5  
I ntr o d u cti o n ............................................................................................................. 1 6 
5. 1  B ac k gr o u n d a n d st u d y r ati o n al e ..................................................................................................... 1 6  
5. 2  L u m e nti n ® 4 4 ................................................................................................................................... 1 6 
5. 3  Cli nic al d ev el o p m e nt t o d at e ........................................................................................................... 1 7  
5. 4  Ris k- B e n efit Ass ess m e nt .................................................................................................................. 1 8  
6  
Tri al O bjecti v es ....................................................................................................... 1 9  
6. 1  Pri m ary O bj ectiv e ............................................................................................................................ 1 9  
6. 2  S ec o n d ar y O bj ectiv es ...................................................................................................................... 1 9  
7  
O ver all D esi g n a n d Pl a n of t he Tri al..................................................................... 1 9  
7. 1  Tri al Ov ervi e w ................................................................................................................................. 1 9  
7. 2  O utc o m es ........................................................................................................................................ 2 0  
7. 2. 1  
Pri m ar y O utc o m e .................................................................................................................. 2 0  
7. 2. 2  
S ec o n d ar y O utc o m es ............................................................................................................. 2 0  
7. 3  J ustific ati o n of t h e Tri al D esi g n ....................................................................................................... 2 0 
7. 3. 1  
J ustific ati o n f or D esi g n a n d P ar a m et ers ................................................................................ 2 0 
7. 3. 2  
J ustific ati o n f or R o ut e a n d D os a g e ........................................................................................ 2 1 
8  
Tri al P o p ul ati o n ...................................................................................................... 2 3  
8. 1  I ncl usi o n Crit eri a ............................................................................................................................. 2 3 
8. 2  Excl usi o n Crit eri a ............................................................................................................................. 2 3  
8. 3  S u bj ect Wit h dr a w al a n d R e pl ac e m e nt ............................................................................................ 2 4  
8. 3. 1  
Wit h dr a w al fr o m Tri al T h er a p y ............................................................................................. 2 4  
8. 3. 2  
Wit h dr a w al fr o m St u d y ......................................................................................................... 2 4  
8. 4  D efi niti o n of E n d of St u d y ................................................................................................................ 2 5  


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 1 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
8. 5  M e dic al C ar e of S u bj ects aft er E n d of St u d y ................................................................................... 2 5  
8. 6  Pl a n n e d S a m pl e Siz e a n d N u m b er of Tri al C e ntr es ......................................................................... 2 5  
9  
I n vesti g ati o n al P r o d uct a n d P r oce d u res ............................................................... 2 6 
9. 1  I n v esti g ati o n al pr o d uct ................................................................................................................... 2 6 
9. 2  D os a g e a n d A d mi nistr ati o n............................................................................................................. 2 7  
9. 3  P ac k a gi n g, L a b elli n g a n d St or a g e ................................................................................................... 2 7  
9. 4  Dr u g Acc o u nt a bility ......................................................................................................................... 2 7  
9. 5  L u m e nti n ® 4 4 Ex p os ur e a n d C o m pli a nc e ......................................................................................... 2 7 
1 0  Pr o hi bite d Pre vi o us a n d C o nc o mit a nt Me dic ati o n ............................................. 2 8  
1 0. 1  
C o nc o mit a nt M e dic ati o n ............................................................................................................ 2 8  
1 0. 2  
P er mitt e d/ Pr o hi bit e d M e dici n es ................................................................................................ 2 8  
1 0. 3  
P er mitt e d/ Pr o hi bit e d Pr oc e d ur es ............................................................................................... 2 8  
1 0. 4  
Pr ec a uti o ns/ o v er d os e ................................................................................................................. 2 9  
1 1  Visit sc he d ule a n d assess me nt descri pti o n ............................................................ 3 0  
1 1. 1  
Visit sc h e d ul e .............................................................................................................................. 3 0  
1 1. 1. 1  
Pr e-scr e e ni n g visit ( Visit 1: D a y - 2 1 t o - 1) ......................................................................... 3 0  
1 1. 1. 2  
Scr e e ni n g visit ( Visit 2: D a y 0) ........................................................................................... 3 0  
1 1. 1. 3  
M R E ex a mi n ati o n visit ( Visit 3: D a y 1 4) ............................................................................ 3 0  
1 1. 1. 4  
Bl o o d s a m pli n g visit ( Visit 4: D a y 1 5) ................................................................................ 3 1  
1 1. 1. 5  
F- U a n d e arl y t er mi n ati o n visit ( Visit 5: Visit 2 2 d a ys) ..................................................... 3 1  
1 1. 2  
Ass ess m e nt d escri pti o ns ............................................................................................................. 3 1  
1 1. 2. 1  
S u bj ect D e m o gr a p h y ........................................................................................................ 3 1  
1 1. 2. 2  
M e dic al Hist or y ................................................................................................................. 3 1  
1 1. 2. 3  
Pr e g n a nc y T est .................................................................................................................. 3 1  
1 1. 2. 4  
C o nc o mit a nt M e dic ati o n .................................................................................................. 3 2  
1 1. 2. 5  
Ass ess m e nt of S af et y ........................................................................................................ 3 2  
1 1. 2. 6  
El ectr olyt e ass ess m e nt ..................................................................................................... 3 2  
1 1. 2. 7  
M R E ex a mi n ati o n .............................................................................................................. 3 2  
1 1. 3  
O utc o m e ass ess m e nts ................................................................................................................ 3 3  
1 1. 3. 1  
Pri m ar y o utc o m es ............................................................................................................. 3 3  
1 1. 3. 2  
S ec o n d ar y o utc o m es ........................................................................................................ 3 4  
1 2  A d v ers e E v e nt S ....................................................................................................... 3 6  
1 2. 1. 1  
A d v ers e R e acti o n .............................................................................................................. 3 6  


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 2 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 2. 1. 2  
U n ex p ect e d A d v ers e R e acti o n .......................................................................................... 3 6  
1 2. 1. 3  
S eri o us A dv ers e E v e nt ...................................................................................................... 3 6  
1 2. 2  
R e p orti n g of A d v ers e Ev e nts ....................................................................................................... 3 7  
1 2. 2. 1  
S ev erit y ............................................................................................................................. 3 7  
1 2. 2. 2  
C a us alit y ............................................................................................................................ 3 8  
1 2. 3  
F oll o w- u p of S u bj ects aft er A dv ers e E v e nts ................................................................................ 3 8  
1 2. 4  
A b n or m al L a b or at ory V al u es ...................................................................................................... 3 8  
1 2. 5  
R e p orti n g of S eri o us A d v ers e Ev e nts .......................................................................................... 3 8  
1 2. 6  
Pr ec a uti o ns/ Ov er d os e ................................................................................................................ 4 0  
1 3  St atistic al Met h o ds .................................................................................................. 4 1  
1 3. 1  
G e n er al st atistic al c o nsi d er ati o ns .............................................................................................. 4 1  
1 3. 2  
S a m pl e Siz e ................................................................................................................................. 4 1  
1 3. 3  
A n alys es S ets .............................................................................................................................. 4 1  
1 3. 4  
D escri pti o n of St atistic al A n alys es .............................................................................................. 4 1  
1 3. 5  
D at a c oll ecti o n ........................................................................................................................... 4 1  
1 4  E T HI C S ................................................................................................................... 4 2  
1 4. 1  
I n d e p e n d e nt Et hics C o m mitt e e (I E C) .......................................................................................... 4 2 
1 4. 2  
Et hic al C o n d uct of t h e Tri al ........................................................................................................ 4 2  
1 4. 3  
S u bj ect I nf or m ati o n a n d C o ns e nt ............................................................................................... 4 2  
1 4. 4  
S u bj ect D at a Pr ot ecti o n .............................................................................................................. 4 3  
1 4. 5  
Ot h er Et hic al a n d R e g ul at ory Iss u es ........................................................................................... 4 3  
1 4. 6  
Et hic al C o nsi d er ati o n st at e m e nt ................................................................................................ 4 3  
1 5  D at a M a n a ge me nt a n d Q u alit y Ass ur a nce ........................................................... 4 4  
1 5. 1  
Q u ality Ass ur a nc e ....................................................................................................................... 4 4  
1 5. 2  
Tri al M o nit ori n g ......................................................................................................................... 4 4  
1 5. 3  
C o nfi d e nti ality ............................................................................................................................ 4 5  
1 5. 4  
S o urc e D at a ................................................................................................................................ 4 6  
1 5. 5  
C as e R e p ort F or ms ( C R Fs) ........................................................................................................... 4 7  
1 5. 6  
D at a M a n a g e m e nt ..................................................................................................................... 4 7  
1 5. 7  
Arc hivi n g Tri al R ec or ds ............................................................................................................... 4 7  


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 3 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 6  Tri al M a n a ge me nt .................................................................................................. 4 9  
1 6. 1  
Ti m e Sc h e d ul e ............................................................................................................................. 4 9  
1 6. 2  
Pr ot oc ol A m e n d m e nts ................................................................................................................ 4 9  
1 6. 3  
A gr e e m e nts ................................................................................................................................ 4 9  
1 6. 4  
D ur ati o n of t h e Tri al ................................................................................................................... 4 9  
1 6. 5  
C o m pl eti o n of Tri al ..................................................................................................................... 4 9  
1 6. 5. 1  
Tri al C o m pl eti o n Pr oc e d ur es ............................................................................................ 4 9  
1 6. 6  
Li a bility a n d I ns ur a nc e ................................................................................................................ 5 0  
1 6. 7  
Us e of i nf or m ati o n...................................................................................................................... 5 1  
1 6. 8  
P u blic ati o n P olic y ....................................................................................................................... 5 1  
1 7  Refe re nce List .......................................................................................................... 5 2  
1 8  A p p e n di ces ............................................................................................................... 5 3  
1 8. 1  
A p p e n dix 1: L u m e nti n 4 4 r ec o nstit uti o n pr ot oc ol s u m m ary ...................................................... 5 3  
1 9  SI G N A T U R E P A G E S ............................................................................................ 5 6  
 
 
 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 4 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
4  
L I S T O F A B B R E V I A T I O N S A N D D E F I N I T I O N S O F T E R M S 
A b d- C T  
A b d o mi nal C o m p uterise d t o m o gra p h y 
A D R  
A d verse Dr u g Reacti o n 
A E  
A d v ers e E v e nt 
A T C  
A nat o mical T hera pe utic C he mical 
A SI  
A d diti o nal Safet y I nf or mati o n  
b. w.  
B o d y wei g ht 
C D  
Cr o h n’s Disease 
CI  
C o nfi de nce I nt er v al 
C R F 
C T 
C ase Re p ort F or m 
C o m p uterise d T o m o gra p h y 
C T E  
C o m p uterise d T o m o gra p h y - e nt er o gra p h y 
C R O  
Cli nical Researc h Or ga ni zati o n 
D M F  
Dr u g Master File 
D R L  
Dr u g Refere n ce List 
E C  
E ur o pea n C o m m u nit y 
E E A  
E ur o pea n Ec o n o mic Area 
E M A  
E ur o pea n Me dici n es A ge nc y 
E U  
E ur o pea n U ni o n 
E W P  
E g g W hite Pr otei n (als o referre d t o as e g g al b u me n) 
F A  
F ull A nal ysis 
G C P  
G o o d Cli nical Practi ce 
G d  
G d G a d oli ni u m 
(e) G F R  
(esti m ate d) Gl o m er ul ar Filtrati o n Rate 
GI  
Gastr oi ntesti nal 
G R A S  
Ge nerall y Rec o g nize d as S afe 
H U  
H o u nsfiel d U nits 
H Vs  
Healt h y V ol u nteers 
I B  
I n v esti gat or Br oc h ure 
I C H  
I nter n ati o nal C o u ncil f or Har m o nisati o n of Tec h nical Re q uire me nts 
f or P h ar mace uticals f or H u ma n Use 
I E C  
I n d e pe n de nt Et hics C o m mitt ee 
I M P  
I n v esti gati o nal Me dici n al Pr o d u ct 
I P  
I n v esti gati o nal Pr o d uct 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 5 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
I V  
I ntr a v e n o us 
M R E  
Ma g neti c Res o n a nce - e nt er o gra p h y 
M RI  
Ma g neti c Res o n a nce I ma gi n g 
Me d D R A  
Me dical Dicti o n ar y f or R e g ulat or y Acti vities 
P h. E ur.  
E ur o pea n P h ar mac o pei a 
P o C  
Pr o of of C o nce pt 
R C D A S  
Ra di ol o gical Cr o h n’s disease A cti vit y S c ore 
R C E  
R el ati v e C o ntrast E n ha nce me nt 
R F  
R a di o Fre q ue nc y 
R OI  
R e gi o n of I nterest 
S A E  
Seri o us A d verse E v e nt 
S A P  
Statistical A n al ysis Pla n 
S T D  
Sta n dar d De viati o n 
S D V  
S o urce Data Verifi cati o n 
S U S A R  
S eri o us U ne x p ect e d S us pecte d A d verse R eacti o ns 
T E A E  
Treat me nt- E mer ge nt A d verse E ve nt 
T E A D R  
Treat m e nt- E mer ge nt A d verse Dr u g Reacti o n 
T M F  
Trial Master Fil e 
V/ V  
V ol u me p er v ol u me 
W/ W  
Wei g ht p er wei g ht 
W H O  
W orl d Healt h Or ga nisati o n 
 
 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 6 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
5  
I N T R O D U C T I O N 
5. 1  
B ac k gr o u n d a n d st u d y r ati o n ale 
L u me nti n ® 4 4 is bei n g de vel o p e d as a n o vel oral c o ntrast me di u m t o be use d i n 
dia g n ostic e xa mi nati o ns of t he a b d o me n. I nitial cli nical d e vel o p me nt has f oc use d 
c o m p uterize d t o m o gra p h y ( C T) ( Lea n der et al., 2 0 2 2; Lea n der et al., 2 0 2 2) w hile t he 
prese nt trial ai ms t o e x pl ore if t he si g n al c h aract eristics of L u me nti n ® 4 4 is fa v o ura bl e i n 
Ma g netic res o na nce e nt er o gra p h y ( M R E), a s p ecialize d t y pe of ma g n etic res o n a nce 
i ma gi n g ( M RI) p erf or me d wit h a c o ntrast materi al t o pr o d uce detail e d i m a ges of t he 
s mall i nt esti ne. 
Oral c o ntrast a g e nts are use d pri or t o a b d o mi nal C T (a b d- C T) a n d C T of t he s m all b o wel 
( C T-e nter o gra p h y, C T E) t o d e marcate b o wel l o o ps fr o m its s urr o u n di n gs a n d t o create a 
differe n ce i n d e nsit y bet w ee n t he b o w el a n d ot h er str uct ures i n t he a b d o m e n. Till n o w, 
t he o nl y c o ntrast a ge nts a v aila bl e a n d use d f or dia g n osis i n a b d- C T are p ositi ve, wit h 
H o u nsfiel d U nits ( H U) ar o u n d + 8 0, or ne utral, i.e., wit h H U ar o u n d a n d a b o ve zer o. B ot h 
a ge nt t y pes pr o vi de C T-i ma ges wit h u nsatisfact oril y l o w c o ntrast bet w ee n t he wall a n d 
l u me n of t h e s mall i nt esti ne. He nce, t h ere is a c o nsi d era ble nee d f or a b o wel filli n g 
c o ntrast a ge nt wit h tr ue n e gati ve H U t h at w o ul d offer n ota bl y lar ger l u me n-t o- wall 
c o ntrast, a prere q uisite f or i m pr o ve d m uc osal lesi o n det ect a bilit y.  
A p hase II st u d y ha v e be e n perf or m e d usi n g L u me nti n ® 4 4 as a c o ntrast a ge nt f or C T 
wit h e n c o ura gi n g res ults ( Lea n d er et al., 2 0 2 2). If t he s a me pr o d uct ca n als o b e use d i n 
M R E assess me nt it w o ul d be a n a d va nta ge f or a ra di ol o gi cal de part me nt t o o nl y ha n dle a 
si n gle oral s mall b o wel filli n g c o ntrast me di u m f or b ot h m o daliti es C T a n d M RI. I n 
a d diti o n, L u me nti n ® 4 4 has s h o w n t o ha v e a fa v o ura ble safet y pr ofile a n d ma y be a m ore 
t olera ble alter n ati v e t o t he oral me dia us e d t o da y i n b ot h C T a n d M RI. T his pr o of- of-
c o nce pt ( P o C) trial is perf or me d i n h ealt h y v ol u nt eers ( H Vs) wit h t h e ai m t o s h o w t hat 
L u me nti n ® 4 4 ca n b e us e d as a n oral, s mall b o wel filli n g c o ntrast a ge nt f or M R E.  
5. 2  
L u me nti n ®  4 4  
L u me nti n ®  4 4 is a n o vel, H U- n e gati v e c o ntrast a g e nt w hic h is f or m ulate d as a p o w der f or 
oral f oa m. T he p o w der pr o d uct c o ntai ns e g g w hit e pr otei n ( E W P) as f oa mi n g a ge nt, 
xa nt ha n g u m as sta biliser, p h os p h ate salts as b ufferi n g a ge nts, a n d fla v o uri n g.  
Pri or t o use, t he p o w der is mi xe d wit h water a n d w hi p p e d t o a sta ble f o a m, c o ntai ni n g 
4 4 % v/ v air a n d less t h a n 4 % w/ w dr y matter, w hic h is orall y a d mi nistere d. T he 
w hi p pe d, rea d y t o use L u me nti n ®  4 4 f oa m is sta ble wit h s uita ble c haract eristics (air 
c o nte nt, v ol u me, b u b ble size, h o m o g e neit y, c o nsiste nc y, sta bilit y a n d p alata bilit y) f or at 
least 2 h o urs.  


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 7 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
T he air tra p p e d i n t he f oa m is t he ra di ol o gical ke y c o m p o ne nt t hat ca uses i m pr o ve d 
b o wel l u me n-t o- wall c o ntrast, wit h t he i nterface at t he s urface of t he m u c osal li ni n g of 
t he b o w el wall. T he e xter nal de marcati o n of t he s mall b o wel fr o m s urr o u n di n g or ga ns is 
o n par wit h sta n dar d filli n g a ge nts use d i n a b d- C T e xa mi nati o ns of t o da y, b ut mese nteric 
vessels b or deri n g t h e b o wel wall are ra di ol o gic all y better vis u alize d w h e n l o o ps are fille d 
wit h L u me nti n ®  4 4. T he reas o n f or t his is fe wer i ma ge artefa cts c o m p are d t o dil ut e d 
O m ni p a q ue ® ( O m ni p a q u e) i n t he gastr oi ntesti nal tract ( GI) tract. 
5. 3  
Cli nic al de vel o p me nt t o d ate 
A pre vi o us f or m ulati o n of t he a ge nt, L u me nti n ®  6 0 ( 6 0 % v/ v air), h as bee n teste d i n a 
pil ot I n vesti gat or i nitiate d trial, a p pr o ve d b y t h e l ocal et hics c o m mitt ee a n d l o cal i nstit ut e 
of ra diati o n pr ot ecti o n (ref 1). T he res ults were v ali date d b y 4 e xter nal re vie wers a n d 
s h o we d t h at L u me nti n®  6 0 i n its b o wel filli n g ca p acit y was o n par wit h c o nte m p oraril y 
use d b o wel filli n g a ge nts ( O m ni pa q ue a n d M o v pre p ® , M o v pre p). F urt her m ore, it was 
s u peri or i n c o ntrast bet w ee n b o wel l u me n a n d wall a n d re veale d a fa v o ura bl e pr ofile of 
si de effects wit h n o or o nl y mil d s y m pt o ms s u c h as b ur pi n g a n d f ull n ess wit h preser ve d 
b o wel c o nsiste nc y. T he pr o misi n g res ults o bt ai ne d wit h L u me nti n ®  6 0 e nc o ura ge d 
i m pr o ve d f or m ulati o n, lea di n g t o L u me nti n®  4 4, a n d c o nti n u e d cli nical de v el o p me nt t o 
f urt h er e x pl ore t he cli nical i m p orta nce of t he i m pr o v e d c o ntrast bet w ee n b o wel l u me n 
a n d b o wel wall wit h L u me nti n ®  4 4. A sec o n d g oal f or t he ne w f or m ulati o n was t o 
g uara ntee hi g h pati e nt acce pta nc e. 
L u me nti n ®  4 4 has b ee n i n vesti gate d i n t w o p hase II trials: 
I n t he c o m pl et e d a n d re p ort e d L U M- 0 0 1 tri al ( L ea n der et al., 2 0 2 2), t he relati ve mea n 
differe n ce i n c o ntrast de nsit y s h o w n o n a b d o mi nal C T-i m a ges w he n usi n g t h e c o ntrast 
a ge nt L u me nti n ®  4 4, was c o m pare d wit h a b d o mi n al C T-i ma ges usi n g dil ute d O m ni pa q u e 
a n d wit h a b d o mi nal C T-i ma ges usi n g M o v pre p i n s u bj ects referre d t o c o m p uterize d 
t o m o gra p hi c X-ra y e xa mi n ati o n of t he a b d o me n or t h orac o-a b d o mi nal C T-e xa mi nati o n.  
E val u ati o n of cli nical safet y data c o nfir m t he fa v o ura ble safet y pr ofile s h o w n wit h 
L u me nti n ®  4 4. T h e differe nce i n c o ntrast de nsit y bet wee n b o w el l u me n a n d b o wel wall 
was si g nifica ntl y lar ger aft er i nta ke of L u me nti n ®  4 4 as c o m pare d wit h t he c o m parat or 
c o ntrast a ge nts M o v pre p a n d O m ni pa q ue. T h ere w as n o statisti cal differe nce i n b o wel 
filli n g pr o perties. Neit h er was t here a n y differe nce i n di a g n ostic a bilit y bet wee n 
L u me nti n ®  4 4 a n d M o v pre p or O m ni pa q ue i n t his p atie nt p o p ulati o n ( w hic h ha d neit h er 
b o wel disease n or b o wel s y m pt o ms). T he s u bj ects’ assess me nts of taste, s mell, 
c o nsiste nc y, a bilit y t o s wall o w, a n d f ull ness place d L u me nti n ®  4 4 bet wee n O m ni p a q ue 
a n d M o v pre p. 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 8 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
I n trial L U M- 0 0 2, t he Ra di ol o gi cal Cr o h n’s disease Acti vit y Sc ore ( R C D A S) of a C T E 
perf or me d wit h L u me nti n ® 4 4 as a b o wel filli n g c o ntrast a ge nt w as c o m p are d wit h t he 
R C D A S of a r o uti nel y p erf or me d M R E i n patie nts wit h s m all b o wel Cr o h n’s disease. 
E val u ati o n of cli nical safet y data c o nfir ms t he fa v o ura ble safet y pr ofile s h o w n i n tri al 
L U M- 0 0 1. T his trial has bee n c o m plete d b ut efficac y e v al u ati o n is o n g oi n g. 
F urt her details are a vaila bl e i n t h e L u me nti n ® 4 4 I n v esti g at or Br oc h ur e (I B). 
5. 4  
Ris k- Be nefit Assess me nt   
E W P is wi del y use d as a f o o d i n gre die nt. All e xci pie nts i n L u me nti n ®  4 4, are of 
p har mac o p o eia q ualit y ( b uffer a n d st a biliser). T h e fla v o ur c o m plies wit h re g ulati o ns 
c o ncer ni n g fla v o uri n g i n f o o d a n d f o o d a d diti v es.  
T he si d e effects re p orte d b y s u bjects dri n ki n g u p t o 1. 2 L of t he L u me nti n ®  4 4 
f or m ulati o n i n pre vi o usl y c o n d uct e d trials i n dicate t hat L u m e nti n®  4 4 was well t olerate d 
wit h o nl y mil d t o m o d erate A Es re p ort e d.  
All er gic reacti o ns t o war ds e g g pr otei n ca n n ot b e e xcl u de d a n d pati e nts wit h a k n o w n 
se nsiti vit y t o war ds e g g s h o ul d n ot be e x p ose d t o L u me nti n ®  4 4.  
I n g esti o n of a lar g e v ol u me of f oa m i n a s h ort ti m e ma y ha ve a n i m p act o n t h e res or pti o n 
patter n of c o n c o mita nt me dicati o ns. I nta ke of ot her me dicati o ns, w hic h are a bs or be d i n 
t he s mall b o wel, a n d ha vi n g a narr o w t h era p e uti c wi n d o w, s h o ul d b e a v oi d e d wit hi n a 
peri o d of 4 h o urs bef ore a n d u ntil 1 h o ur after a d mi nistrati o n of L u me nti n ®  4 4. 
P ote ntial si d e effects ass oci at e d wit h i ntra ve n o us (I V) cat heterizati o n i ncl u d e i nserti o n 
site pai n, p hle bitis, he mat o ma f or mati o n a n d i nf us ate e xtra v asati o n. Mec h a ni cal iss u es 
s uc h cat heter o bstr ucti o n/ occl usi o n a n d disl o d ge me nt ma y occ ur. T he h os pital sites st aff 
is ver y fa miliar a n d al ert t o si g ns a n d s y m pt o ms of s uc h c o m plicati o ns, a n d pre ve nti v e 
meas ures are i n pl ace, as well as i nter v e nti o n pr o ce d ures f or if/ w h e n c o m plicati o ns d o 
occ ur. T h e I V cat heter will re mai n i n pl ace f or t h e d urati o n of t he visit 2 ( da y of M R E 
pr oce d ur e), u ntil c oll ecti o n of 8 h bl o o d sa m ple.  
T he pr o p ose d P hase II st u d y will e nr ol o nl y H Vs a n d as s uc h n o direct b e nefit is e x pect e d 
f or t he trial s u bjects. 
Ris ks ass oci ate d wit h C o vi d- 1 9  
C o nsi deri n g t hat t he s u bjects i n t h e trial will b e H Vs, t he ris k of c o ntracti n g C O VI D- 1 9, 
as part of t he trial pr oce d ures is c o nsi d ere d l o w.  
All s u bject visits t o t h e h os pital will occ ur i n faciliti es w hi c h are n ot use d f or patie nts 
wit h C O VI D- 1 9. Pr oce d ures t o pre ve nt C O VI D- 1 9 i nfecti o n, as rec o m m e n de d b y t he 
S we dis h “f ol k häls o m y n di g h ete n”, will b e f oll o we d.  
 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
1 9 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
6  
T R I A L O B J E C T I V E S 
6. 1  
Pri m a r y O bjecti ve 
T o e val u ate if L u m e nti n ®  4 4 use d as a s mall b o w el filli n g a ge nt i n M R E e xa mi nati o n 
ge nerat es i ma ges wit h acce pta bl e di a g n ostic q ualit y. 
6. 2  
S ec o n d ar y O bjecti ves 
 T o e val u ate plas ma electr ol yt es i n cl u di n g, p otassi u m, s o di u m, p h os p hate, a n d 
calci u m, as well as i o nize d cal ci u m c o n ce ntrati o n le vels d uri n g 2 4 h o urs after i nt a k e 
of L u m e nti n ®  4 4. 
 T o e val u ate b o w el filli n g pr o perties (e xte nsi o n a n d diste nsi o n) of L u me nti n ®  4 4. 
 T o e val u ate t h e s afet y a n d t ol era bilit y of L u me nti n ®  4 4 i nt a ke. 
7  
O V E R A L L D E S I G N A N D P L A N O F T H E T R I A L 
7. 1  
Tri al O ver vie w 
T his is a n u nc o ntr olle d, si n gle ce ntre p h ase II trial. E nr olle d H Vs ( n = 1 0) will u n der g o 
G d-e n ha n ce d M R E after oral i nt a k e of L u me nti n ® 4 4. 
I ntereste d H Vs will be i de ntifi e d pri maril y a m o n g m e dical st u de nts at t he me di cal 
h os pitals at Mal m ö a n d L u n d. P osters will be place d at t he d e p art me nts a n d i n vitati o n 
lett ers will be ha n de d o ut. 
T he H Vs i ntereste d i n partici p ati n g will be i n vite d t o atte n d a pre-scree ni n g visit w h ere 
t heir s uit a bilit y base d o n a ge a n d h ealt h stat us will b e assesse d. Fiftee n H Vs w h o f ulfil 
t he pre-scree ni n g criteria a n d are i ntereste d i n parti ci pati n g will be as k e d t o atte n d a 
scree ni n g visit at t he cli ni c a n d if eli gi ble f or t he trial t h e y will t he n visit t he cli nic f or t he 
M R E assess me nt wit hi n 1- 2 wee ks.   
O nl y t he i nitial 1 0 of t h e eli gi ble H Vs will be as ke d t o c o me f or t he M R E e xa mi nati o n 
a n d t he re mai ni n g eli gi bl e s u bjects will be as ke d t o sta n d b y i n case a n y of t he 1 0 
s u bj ects are u n a ble t o c o me or ca n n ot u n der g o t he e xa mi nati o n. 
H Vs will be as ke d t o fast f or 6 h o urs pri or t o t he e xa mi nati o n o n t he d a y of t h e M R E 
e xa mi nati o n. S m all a m o u nt of clear li q ui d is all o we d u p t o 2 decilitres. Pri or t o M R E, 
L u me nti n ®  4 4 will b e pr o vi de d t o t he m i n v ol u mes of u p t o 1, 5 0 0 m L a n d at least 1, 1 0 0 
m L of L u me nti n ® 4 4 m ust be dr u n k. T h e s u bj ects will b e as ke d t o dri n k t h e s ol uti o ns of 
oral c o ntrast a g e nt wit hi n 4 5 mi n utes t o 1 h o ur.  
S u bjects n ot a ble t o dri n k at least 1. 1 L of L u me nti n ® 4 4 will be wit h dra w n fr o m t he 
trial. 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 0 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
Pri or t o t he i nt a k e of L u me nti n ®  4 4, a n I V a ntec u bital ca n n ula will be place d a n d use d f or 
bl o o d sa m pli n g a n d a d mi nistrati o n of g a d oli ni u m ( G d) c o ntrast a ge nt d uri n g t he M R E 
assess me nt. 
7. 2  
O utc o mes 
7. 2. 1  Pri m ary O utc o me 
Vis u al e val uati o n of t he M R E i ma ges fr o m eac h trial s u bject wit h res pect t o m otilit y, 
artefacts, m uc osal e v al uati o n a n d o v erall di a g n ostic i m pressi o n. 
7. 2. 2  S ec o n d ary O ut c o mes 
 C o n ce ntrati o n of plas ma electr ol ytes i ncl u di n g, p otassi u m, s o di u m, p h os p hate, a n d 
calci u m, as well as i o nize d cal ci u m i n bl o o d sa m pl es ta ke n at T 0 h, T 1 h, T 2 h, T 4 h, 
T 6 h, T 8 h, a n d T 2 4 h. 
 B o wel filli n g pr o perties (e xte nsi o n a n d dist e nsi o n) i n eac h of 5 s electe d s u b-se g me nts 
of t h e s mall b o wel. 
 A n y treat me nt e mer ge nt a d verse e v e nts ( T E A Es) a n d treat me nt e m er ge nt a d verse 
dr u g reacti o ns ( T E A D Rs). 
7. 3  
J ustific ati o n of t he Tri al Desi g n 
7. 3. 1  J ustific ati o n f or Desi g n a n d P ar a meters 
L u me nti n ®  4 4 is c urre ntl y bei n g de vel o pe d t o be use d as a s mall b o wel filli n g c o ntrast 
a ge nt w he n C T e x a mi nati o n is perf or me d. T w o cli nical trials ha ve s o far bee n p erf or me d 
a n d a p h ase 3 trial is pla n n e d t o start 2 0 2 3.  
M ost ra di ol o g y de part me nts perf or m b ot h C T a n d M R E e xa mi nati o ns a n d it is 
a d va nta ge o us a n d c o n ve nie nt f or t he m t o b e a ble t o pr o vi de t h e sa me oral c o ntrast a ge nt 
f or b ot h pr oce d ures. L u m e nti n®  4 4 is f o o d base d wit h Ge nerall y Re c o g niz e d as Safe 
( G R A S) e xci pie nts a n d h as i n t he pre vi o us cli nical trial bee n acce pt e d a n d t olerate d w ell 
wit h o nl y mil d t o m o d erate A Es re p ort e d. I n t he L U M- 0 0 1 trial i n s u bjects referre d f or 
a b d o mi nal C T-e xa mi nati o n t hat e val u at e d t he C T i ma ge q u alit y a n d dia g n ostic feasi bilit y 
of L u m e nti n ® 4 4 i n c o m paris o n wit h dil ut e d O m ni p a q ue a n d M o v pr e p, t he m ost 
c o m m o n T E A Es i n t he L u me nti n ®  4 4 ar m, were flat ule nce ( 4 s u bj ects, 2 2 %) a n d na us ea 
( 2 s u bj ects, 1 1 %). I n t h e L U M- 0 0 2 cli nical trial i n pati e nts wit h s mall b o wel Cr o h n’s 
disease t hat e val uate d L u m e nti n ® 4 4 as c o ntrast a ge nt i n C T-e nter o gra p h y as c o m par e d 
t o M R E, t h e m ost c o m m o n ( occ urri n g i n ≥2 s u bjects) T E A Es, i n t he L u me nti n®  4 4 ar m, 
were diarr h oea ( 1 0 s u bjects, 1 8 %), na usea ( 3 s u bjects, 5 %), a n d flat ule nce ( 2 s u bj ects, 
4 %). 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 1 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
T o be a ble t o use L u me nti n ® 4 4 i n M R E, t he dia g n ostic q ualit y ca n n ot be i nferi or t o t he 
sta n dar d oral re gi me n. T heref ore, t he trial select e d pi v otal p ara meters i n rea di n g M R E as 
pri mar y e n d p oi nts.  
As t he air i n L u me nti n ma y de gra d e t h e i ma ge q u alit y i n M RI i n t he i nterface t o s oft 
tiss ue t he m ost rel e va nt p ara met ers were c h os e n. I n m otilit y se q ue nces t h e m o vi n g s mall 
i ntesti ne fille d wit h air ma y a g gra v at e t h e pr o ble m a n d t he ot her para meters w here t he 
s mall i nt esti ne s h o ul d re mai n still it is m ost rele va nt t o scr uti nize t he str uct ures, e. g., 
m u c osal f ol ds, i n t h e i nterface b et w ee n air a n d s oft tiss u es. 
It is i m p orta nt f or t he q u alit y of t he M R E i ma ges t h at t he s m all b o wel is a de q uatel y fille d 
wit h t h e c o ntrast a g e nt. T h e cli nical e n d p oi nt meas uri n g filli n g pr o perties is t heref ore 
i ncl u de d. E xte nsi o n is t he meas ure me nt of h o w far d o w n i n t h e s mall b o wel t he c o ntrast 
a ge nt has reac h e d, a n d t he diste nsi o n p ara meter meas ures t he h o w diste n de d ( wi d e ne d) 
t he s mall b o wel is.  
P alata bilit y of t he c o ntrast a ge nt is a n i m p orta nt fact or f or t he s u bject’s acce pt a nce a n d 
a bilit y t o dri n k it. T he s u bjects are t h eref or as k e d t o e val uate feat ures d escri bi n g h o w 
t he y e x p erie n ce dri n ki n g t he L u me nti n®  4 4 f oa m. 
T he c h oi ce of n ot i n cl u di n g a c o m p arat or a n d e x p ose t he H V t o a n ot h er c o ntrast a ge nt 
ha ve b ee n ma de b ase d o n t h at t he ai m of t h e tri al is t o i n vesti gate t he ge neral q ualit y of 
t he M R i ma ges w h e n usi n g L u me nti n®  4 4, a n d t hat b ot h t h e i n v esti g ati o nal M R E 
e xa mi nati o n a n d t h e dr u g L u me nti n ®  4 4 are safe t o use. Fr o m a m e dical, e m pirical, 
pers pecti ve it is n ot c o nsi d ere d necessar y t o i ncl u d e m ore t h a n 1 0 s u bjects t o ge nerate 
data s ufficie nt f or s h o wi n g P o C. T h e sa m pl e size is n ot deter mi n e d o n a n y mat he mati cal 
gr o u n ds as t his is a P o C trial.  
H Vs t o be e nr olle d i n t he trial m ust be a ble t o u n der g o a n M R E e x a mi nati o n a n d s h o ul d 
n ot h a ve a n y k n o w n e g g all er g y. 
7. 3. 2  J ustific ati o n f or R o ute a n d D os a g e  
A t ot al of 7 3 s u bjects i n pre vi o us cli nical trials ( L U M- 0 0 1 a n d L U M- 0 0 2) were as ke d t o 
dri n k bet w ee n 0. 7 5 - 1. 5 L f oa m a n d t h e a vera ge a m o u nt dr u n k was 1 0 2 6 m L of 
L u me nti n ®  4 4 f oa m. T he a m o u nt of c o ntrast a g e nt t hat a s u bj ect ca n dri n k varies b et w ee n 
s u bj ects de pe n di n g o n e. g., a ge, w ei g ht, ge n d er a n d me dical c o n diti o n. It is t h eref ore 
necessar y t o d efi n e t h e rec o m me n de d d ose wit hi n a ra n ge.  
T his trial will recr uit pre d o mi na ntl y y o u n g H Vs, a n d electr ol yte le vels will be 
i n v esti g at e d. T he ra n ge is t h eref or e narr o wer a n d t h e l o wer li mit i n t h e ra n ge is als o 
hi g her t ha n i n pre vi o us trials. T he l o wer li mit i n t h e d ose ra n g e is set t o 1. 1 L. T he 
rec o m me n de d d os e will b e 1. 2 L wit h t he all o we d u p per ra n ge set t o 1. 5 L.  


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 2 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
T he r o ute of a d mi nistrati o n is acc or di n g t o sta n d ar d practice f or a n oral c o ntrast a ge nt. 
 
 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 3 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
8  
T R I A L P O P U L A T I O N 
T he trial p o p ulati o n will c o nsist of healt h y v ol u nteers. 
T he s u bjects m ust be a bl e t o pr o vi de writte n i nf or me d c o ns e nt a n d me et all t h e i ncl usi o n 
criteria a n d n o ne of t he e xcl usi o n criteria. 
8. 1  
I ncl usi o n Criteri a 
S u bjects will be e ntere d i nt o t his trial o nl y if t h e y meet all t he f oll o wi n g criteria: 
1.  Healt h y v ol u nteers of eit her ge n der at least 1 8 years at t he ti me of si g ni n g t he 
i nf or me d c o nse nt.  
2.  Fe males m ust eit h er prese nt a ne gati v e pre g na nc y test or be s ur gicall y steril e 
( h yst erect o m y or t u b al li gati o n) or p ost me n o p a us al (i.e., e x peri e nce d 1 2 c o nsec uti v e 
m o nt hs wit h o ut me nstr uati o n). 
3.  F oll o wi n g ver bal a n d writte n i nf or mati o n a b o ut t he trial, t he s u bj ect m ust pr o vi d e 
si g n e d a n d date d i nf or m e d c o nse nt b ef ore a n y tri al relate d a cti vit y is carrie d o ut. 
8. 2  
E xcl usi o n Criteri a 
S u bjects will n ot be e nr olle d if t he y m eet a n y of t h e f oll o wi n g crit eria: 
1.  G F R bel o w 6 0 ml/ mi n/ 1. 7 3 s q m b o d y s urface. All s u bjects will ha ve a plas ma 
creati ni n e ta k e n at scree ni n g f or calc ul ati o n of e G F R. 
2.  Hist or y of dr u g relate d reacti o n t o g a d oli ni u m c o ntrast a ge nts. 
3.  Ha ve ha d g a d oli ni u m i nj ecti o n d uri n g t he last 4 w ee ks. 
4.  Cla ustr o p h o bia n ot c o pi n g wit h M R E e xa mi nati o n. 
5.  Metal o bj ects a n d me dical de vi ces i n t h e b o d y n ot j u d ge d b y t h e i n vesti gat or t o be 
c o m p ati ble wit h M R E. 
6.  H y perse nsiti vit y t o B usc o pa n ®  ( B ut yl h y osc o pi n). 
7.  Ha vi n g s w all o wi n g diffic ulties. 
8.  K n o w n aller g y t o e g g al b u me n.  
9.  K n o w n se nsiti vit y t o a n y of t he c o m p o ne nts of t he i n v esti g ati o n al pr o d uct. 
1 0.  Cli ni cal s us pici o n of o n g oi n g disease b y t he i n vesti gat or.  
1 1.  Bei n g, i n t he o pi ni o n of t h e i n v esti g at or, u nli k el y t o c o m pl y wit h t he cli nical trial 
pr ot oc ol. 
1 2.  Pre vi o usl y ra n d o mize d t o p artici pate i n t his trial. 
1 3.  P artici pati n g i n or ha vi n g partici p ate d i n a n ot her cli nical tri al wit hi n t he last 4 wee ks.  


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 4 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
8. 3  
S u bject Wit h d r a w al a n d Re pl a ce me nt 
8. 3. 1  Wit h dr a w al fr o m Tri al T her a py 
S u bjects m ust be wit h dra w n if t he i nta ke of t he c o ntrast a ge nt has t o be st o p pe d, pl ease 
see secti o n 9. 2 D osa ge a n d A d mi nistrati o n. 
8. 3. 2  Wit h dr a w al fr o m St u dy 
S u bjects ma y wit h dra w fr o m t he trial at a n y ti m e a n d f or a n y reas o n wit h o ut prej u dice t o 
his or her f ut ure me dical care. 
S u bjects m ust be wit h dra w n u n der t he f oll o wi n g circ u msta nces: 
 T he s u bject wit h dra ws c o nse nt 
 S u bj ects w h o ha ve n ot faste d (clear water all o we d) f or at le ast si x h o urs pri or t o 
t he i nta ke of t he c o ntrast a ge nt  
 T he s u bject is u na ble t o dri n k at least 1. 1 L of L u me nti n ®  4 4 
 T he s u bject is u na ble t o c o m plete t h e M R E e xa mi n ati o n, d ue t o e. g., 
cl a ustr o p h o bia.  
 Vi ol ati o n of eli gi bilit y criteria 
S u bjects wit h dra w n d ue t o t h e a b o ve circ u msta nces will be re place d b y o n e of t h e fi v e 
re mai ni n g eli gi bl e H V s u bjects o n sta n d b y after scree ni n g.  
S u bjects ma y be re q uir e d t o wit h dra w after disc ussi o n wit h t h e S p o ns or a n d/ or 
I n v esti gat or f or t h e f oll o wi n g reas o ns: 
 A Es 
 Use of pr o hi bite d me dicati o n (see Secti o n 1 0 ) 
 At t h e discreti o n of t h e I n vesti g at or 
I n all cases, t h e reas o n(s) f or wit h dra wal m ust be rec or de d o n t h e Case Re p ort F or m 
( C R F). If a s u bject is pre mat urel y wit h dra w n fr o m t he trial f or a n y reas o n, t he 
I n v esti gat or m ust ma ke e ver y eff ort t o p erf or m t h e e val uati o ns descri b e d f or t h e Earl y 
Ter mi nati o n Visit (see S ecti o n Fel! Hitt ar i nte refere ns k äll a. ). 
If a s u bject has wit h dra w n i nf or me d c o nse nt a n d still a grees t o atte n d t he E arl y 
Ter mi nati o n Visit, t his will be d oc u me nt e d o n t h e C R F. 
F or s u bjects w h o are wit h dra w n after t he y recei v e t h e trial dr u g, t h e Earl y Ter mi n ati o n 
pa ge will be c o m pl ete d i n t he C R F.  
H Vs wit h dra w n pri or or d uri n g t h e M R E e xa mi nati o n (i.e., n o e val ua ble M R E sca n has 
bee n ge nerate d) will be r e place d b y a ne w H V. H Vs wit h dra w n after t he c o m pleti o n of 
M R E e xa mi n ati o n a n d N O T f ulfilli n g t he ma n dat or y criteria f or wit h dra w al liste d a b o ve 
will n ot be re place d.  


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 5 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
8. 4  
Defi niti o n of E n d of St u d y 
T he e n d of trial visit will be t h e last s u bject last visit w hic h will occ ur at t he f oll o w u p 
visit, t w o da ys after t he M R E e xa mi n ati o n, or i n case of a n o n g oi n g A E at t he f oll o w u p 
visit, a n y a d diti o n al visit re q uire d f or A E f oll o w- u p. 
8. 5  
Me dic al C are of S u bjects after E n d of St u d y 
T he trial will o nl y i n cl u de healt h y v ol u nteers a n d t here is t heref ore n ot n ee d f or me dical 
care after t he trial. H o w e ver, i n cas e t he M R E e xa mi nati o n re veals a n y rele va nt 
pre vi o usl y u n k n o w n me dical c o n diti o n, t he s u bj ect will be i nf or me d a n d g ui de d t o 
c o ntact a p pr o pri at e me di cal e x p ertise. 
8. 6  
Pl a n ne d S a m pl e Si ze a n d N u m b er of Tri al Ce ntres 
It is pla n ne d t o e nr ol 1 0 e val ua ble s u bj ects i n a si n gle cli nical site.  
 
 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 6 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
9  
I N V E S T I G A T I O N A L P R O D U C T A N D P R O C E D U R E S 
9. 1  
I n vesti g ati o n al p r o d uct 
L u me nti n ®  4 4 P o w der f or oral f oa m (Ta ble 1 ) will b e ma n ufact ure d b y A p ote k 
Pr o d ucti o n & La b orat ori es A B, Pris ma vä ge n 2, S E- 1 4 1 7 5 K u n ge ns K ur v a, S we de n a n d 
pr o vi d e d i n la belle d w hit e sac hets c o ntai ni n g 1 7. 4 g p o w der. P ota bl e w ater 
(c o m merciall y a vail a ble still water 0. 5 L p er b ottle) f or t he pre p arati o n of t he f oa m will 
be use d.  
T a bl e 1: L u me nti n ® 4 4 P o w der f or o r al f o a m 
I n gre die nts 
C o nce ntr ati o n ( g/s ac het) 
E g g W hit e P o w der  
1 0. 0  
S o di u m di h y dr o ge n p h os p hate di h y drate 
( Na H2P O 4 • 2 H2O) 1 
1. 0 
Di p otassi u m p h os p hate ( K 2H P O 4) 1 
3. 4  
Xa nt ha n g u m 1 
2. 5  
Fl a v o ur 2 
0. 5  
1)  P h. E ur.: E ur o pea n P har mac o peia 
2)  T he fla v o ur c o m pli es wit h t he re g ulati o ns ( E C) 1 3 3 4/ 2 0 0 8 a n d ( E C) 1 7 8/ 2 0 0 2 
c o ncer ni n g fla v o uri n g i n f o o d a n d f o o d a d diti ves.  
 
L u me nti n ® 4 4 p o w der f or oral f oa m will b e d eli v ere d fr o m A P L t o t he cli ni cal site, b y 
or der via t h e h os pital p har mac y a n d st ore d te m p oraril y at t he sit e. T he i n vesti g ati o n al 
pr o d uct ( L u me nti n ® 4 4 f o a m) is t he n pre pare d i n-sit u b y a d di n g 0. 5 L p ota bl e water t o 
L u me nti n ® 4 4 p o w der c o ntai n e d i n o ne sac h et, a n d t he ble n d is t he n mi x e d t o a sta ble 
f oa m i n a d e dic at e d pre p arati o n u nit. T he fres hl y pre pare d f oa m will be a d mi nistere d t o 
t he patie nt wit hi n 5 t o 1 0 mi n utes as direct e d i n t h e cli nical trial pr ot oc ol. T he i n-
sit u pre parati o n will f oll o w a pr oce d ure attac h e d t o t h e cli nical trial pr ot o c ol. T he st aff 
res p o nsi ble f or t he i n-sit u pre parati o n will b e trai ne d usi n g t he pr oce d ure a n d t heir 
trai ni n g d oc u me nt e d i n t he Trial M ast er File ( T M F). T w o s ac hets ( 0. 9 L f o a m per sa c het) 
will be re q uire d p er s u bject.  
F or a detaile d des cri pti o n of t he pre p arati o n of L u me nti n ®  4 4 F o a m (see A p p e n di x 1 
L u me nti n ®  4 4 : L u m e nti n 4 4 rec o nstit uti o n pr ot oc ol s u m mar y ). 
L u me nti n ®  4 4 F o a m c o ntai ns t h e sa me i n gre die nts as L u me nti n®  4 4 P o w der f or oral 
f oa m, see F el! Hitt ar i nte refere ns k äll a. , e xce pt f or water a d de d d uri n g t h e pre parati o n. 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 7 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
9. 2  
D os a g e a n d A d mi nistr ati o n 
T he I n vesti g ati o nal pr o d ucts will b e ta ke n orall y b y t he s u bject d uri n g a p eri o d of 3 0 
mi n utes - 1 h o ur.  
A v ol u me of 1. 1 L t o 1. 5 L s hall be c o ns u me d. A stea d y i nt a ke rate of t he c o ntrast a ge nt 
is rec o m me n d e d t o g uara ntee f ull ness of t h e g astr oi ntesti n al tract fr o m st o mac h t o 
ter mi n al ile u m of t h e s mall b o wel.  
T he i nta ke of t he c o ntrast a ge nt will be st o p pe d i n case of a n A E occ urs or if t h e s u bject 
is u na bl e t o c o ns u me m ore t h a n 1. 1 L wit hi n 1 a n d ½ h o ur. T he s u bject will be 
wit h dra w n i n cas e t h e i nta ke of t he c o ntrast a ge nt has t o be st o p pe d.  
T he s u bject will b e wit h dra w n fr o m t h e trial if t h e ma xi m u m v ol u me of t he 
I n v esti gati o nal pr o d uct ta ke n b y t h e s u bj ect is l ess t h a n 1. 1 L.  
T here is n o ris k of o v er d ose. 
9. 3  
P ac k a gi n g, L a belli n g a n d St o r a ge 
L u me nti n ® 4 4 p o w der f or oral f oa m will b e s u p pli e d i n w hite sac hets la b elle d acc or di n g 
t o E U- G M P, A n ne x 1 3. Te n sac hets will be pl ace d i n a sec o n dar y pac k a ge c o nsisti n g of 
w hite u n pri nte d car d b oar d. L u me nti n ® 4 4 p o w der f or oral f o a m s h o ul d b e st ore d at r o o m 
te m perat ure ( bel o w 2 5° C) i n a restrict e d area, accessi ble t o a ut h orise d pers o n nel o nl y.  
9. 4  
Dr u g A cc o u nt a bilit y 
T he I n vesti g at or is res p o nsi ble f or mai nt ai ni n g acc urate i n vesti gati o n al pr o d uct 
acc o u nta bilit y rec or ds t hr o u g h o ut t he trial. 
Eac h dis p e nsi n g of i n vesti g ati o nal pr o d uct will b e d oc u me nte d i n t he dr u g acc o u nta bilit y 
l o g a n d t he C R F.  
All u n use d i n vesti gati o nal pr o d uct ( L u me nti n ®  4 4 p o w der f or oral f oa m) will be ret ur ne d 
t o L u me nt A B at t he e n d of t h e trial.  
9. 5  
L u me nti n ®  4 4 E x p os ure a n d C o m pli a n ce 
All L u me nti n ®  4 4 c o nt ai ners will be wei g he d b ef ore t he y are dis p e nse d t o t he s u bject a n d 
a gai n w he n ret ur ne d b y t he s u bject a n d t hese w ei g hts (i n gra m) will be rec or de d i n t he 
C R F. 
T he e xact v ol u me of t he L u me nti n ®  4 4 f oa m i n t h e dri n ki n g c o nt ai ner will be deter mi n e d 
pri or t o dis pe nsi n g it t o t he s u bjects b ut it will b e at least 1. 1 L. T he w ei g ht of t he 
c o ntrast a ge nt will be meas ure d pri or t o dis p e nsi n g a n d a n y re mai ni n g c o ntrast a ge nt will 
be wei g he d after i nta ke. V ol u mes will be n ote d i n t he C R F Dr u g acc o u nta bilit y will be 
carri e d o ut at re g ular i nter v als, as s pecifi e d i n t he m o nit ori n g pla n. 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 8 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
Dr u g e x p os ure will be esti mate d base d o n t he wei g ht of i n gest e d c o ntrast a ge nt a n d t he 
wei g ht of t he s u bject.  
Data fr o m t his trial will be use d t o t he e xt e nt p ossi ble f or pr o vi di n g f ut ure a d vice as of 
h o w m uc h L u me nti n ®  4 4 s h o ul d be use d t o o btai n M R E sca ns wit h g o o d dia g n ostic 
rea da bilit y. 
1 0  P R O H I B I T E D P R E V I O U S A N D C O N C O M I T A N T M E D I C A T I O N 
1 0. 1  C o nc o mit a nt Me dic ati o n 
A n y me dicati o n t he s u bject ta kes ot her t h a n t h e i n vesti gati o nal pr o d u ct ( prescri b e d a n d 
o ver-t he-c o u nter- dr u gs) is c o nsi dere d a c o n c o mita nt me dicati o n. All c o nc o mita nt 
me di cati o ns m ust be rec or de d i n t he C R F. T he f oll o wi n g i nf or mati o n m ust be rec or de d i n 
t he C R F f or eac h c o nc o mita nt me dicati o n: g e neric n a me, r o ute of a d mi nistrati o n, start 
date, st o p date, d osa ge, a n d i n dicati o n. A n y c ha n g es i n t h e d osa ge or re gi m e n of a 
c o nc o mita nt treat m e nt m ust be rec or d e d i n t he C R F. 
At visit 1, s u bjects will be as ke d w h at me di cati o ns t he y ha ve ta ke n d uri n g t he l ast 2 
wee ks bef ore visit 1. C o n c o mita nt m e dicati o ns will be rec or de d at eac h visit a n d d uri n g 
tele p h o ne i nter vie ws, if a p plica ble.  
All s u bjects will recei ve: 
1.  A n i ntra v e n o us i njecti o n of B us c o pa n 4 0 m g. T he d ose gi ve n a n d b atc h n u m ber 
of B usc o pa n 4 0 m g will be n ote d i n t he C R F 
2.  A n i ntra v e n o us i njecti o n of t he G d c o ntrast a ge nt ( Clarisca n ®, 0. 5 M) d uri n g t he 
M R E-e xa mi nati o n at a d ose of 0. 1 m m ol/ k g b. w. T h e v ol u me gi ve n is t y picall y 
1 0 – 2 0 ml. T he d ose gi ve n a n d batc h n u m b er of t h e Clarisca n ®  0. 5 M will be 
n ote d i n t he C R F.  
1 0. 2  Per mitte d/ Pr o hi bite d Me dici nes 
All use of me di cati o n t a k e n b y a n y r o ute will be pr o hi bite d d uri n g 4 h o urs bef ore t a ki n g 
t he c o ntrast a ge nts a n d o ne h o ur p ost t he i nta ke. T hereafter o nl y c o ntrace pti v es a n d 
occasi o nal p ai n killers are all o we d.   
1 0. 3  Per mitte d/ Pr o hi bite d Pr oce d ures 
H Vs s h all n ot u n der g o m ore t ha n n or mal p h ysic al li vi n g d uri n g t he first 2 4 h of t he st u d y, 
mea ni n g t h at trai ni n g a n d har d p h ysical e x ercis e are n ot all o we d. 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
2 9 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 0. 4  Prec a uti o ns/ o ver d ose 
Ris ks ass o ciate d wit h i nt a ke of oral c o ntrast a ge nts i n cl u de d ys p ha gia wit h as pirati o n a n d 
sec o n d ar y p n e u m o nia. Alt h o u g h t his tri al i nte n ds t o e nr ol o nl y h ealt h y v ol u nteers a n d 
s u bj ects wit h ac ute pr o bl e ms are e xcl u de d, a pre-e mer ge nc y s mall b o w el st at us mi g ht be 
a g gra vat e d t o a n esta blis he d il e us b y i n g esti n g a lar ge v ol u me. Oral c o ntrast a ge nts 
s h o ul d n ot b e gi v e n t o s u bc o nsci o us s u bjects, t o t h ose wit h s wall o wi n g dis or ders, or a n 
ac ut e a b d o me n pr o bl e m.  
K n o w n se nsiti vit y or aller g y t o c o ntrast a ge nt i n gre die nts are e xcl usi o n crit eria i n cli ni cal 
st u dies. H o we ver, u n k n o w n se nsiti vities or aller gies mi g ht ca use reacti o ns t h at ma y nee d 
t o be me dicall y treat e d.  
I ntra ve n o usl y a d mi nist ere d G d m a y c a use aller gi c reacti o n of v ari o us se verit y fr o m a 
mil d r us h t o i nt e nsi v e care u nit treat me nt. T his is es peciall y tr ue f or t h ose wit h all er gi c 
reacti o ns t o a c o ntrast a g e nt earlier i n life. Aller gic reacti o n ma y be tri g ge d i n t h ose wit h 
ast h matic br o nc hitis a n d treate d wit h bet a- bl oc kers. R o uti nes f or ha n dli n g t hese cases are 
well k n o w n t o t h e staff w hic h is re g ul arl y trai n e d i n d eali n g wit h e mer ge n c y cases. 
E q ui p me nt f or e mer ge nc y care treat m e nt is a v aila ble at t he cli ni c a n d t he cli ni c is l ocate d 
i n cl ose pr o xi mit y t o t h e h os pit al e mer ge nc y car e de part me nt. Neit her B usc o p a n n or G d 
s h o ul d be a d mi nistere d t o p atie nts wit h se vere ki d ne y fail ure.  
 
 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
3 0 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 1  V I S I T S C H E D U L E A N D A S S E S S M E N T D E S C R I P T I O N 
1 1. 1  Visit sc he d ule  
1 1. 1. 1  Pre-scree ni n g visit ( Visit 1: D ay - 2 1 t o - 1) 
Pre-scree ni n g assess me nts will i ncl u de: 
 Rec or di n g of s u bject i nf or mati o n. 
 Rec or di n g of past m e dic al a n d s ur gical hist or y. 
 Rec or di n g of c o n c urre nt ill ness a n d treat me nts. 
 Eli gi bilit y c hec k wit h re gar ds t o i n cl usi o n criteri o n 1 a n d e xcl usi o n criteria 2, 3, 
4, 5, 6, 7, 8, 1 2 a n d 1 3. 
1 1. 1. 2  S cree ni n g visit ( Visit 2: D ay 0) 
S cree ni n g assess me nts will i ncl u de: 
 O btai ni n g of writte n i nf or me d c o nse nt pri or t o a n y st u d y s pecifi c pr oce d ure 
(i n cl u di n g scree ni n g pr oce d ures) b ei n g perf or me d. 
 Rec or di n g of s u bject i nf or mati o n a n d de m o gra p hi cs i n cl u di n g, date of birt h, se x, 
hei g ht a n d wei g ht 
 Rec or di n g of past m e dic al a n d s ur gical hist or y. 
 Rec or di n g of c o n c urre nt ill ness a n d treat me nts. 
 I n cl usi o n/ e xcl usi o n criteria. 
 Pref or mi n g a p h ysical e xa mi nati o n. 
 Fe males will be as ke d t o u n d erta ke a uri n e pre g na nc y test 
 O btai ni n g a creati ni ne bl o o d sa m pl e 
1 1. 1. 3  M R E e x a mi n ati o n visit ( Visit 3: D a y 1 4) 
D uri n g t his visit t h e M R E e xa mi n ati o n will b e perf or me d, i ncl u di n g t he f oll o wi n g 
assess me nts: 
 Rec or di n g of c o n c o mita nt treat me nts 
 Rec or di n g of A Es 
 Place me nt of t he I V a nt ec u bital ca n n ula 
 Dis p e nsi n g of L u me nti n ® 4 4 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
3 1 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
 M R E e xa mi n ati o n  
o  A d mi nistrati o n of G d c o ntrast 
o  A d mi nistrati o n of B usc o pa n ®  
 E val u ati o n of e xt e nsi o n a n d dist e nsi o n of b o w el filli n g a ge nts 
 Bl o o d sa m pli n g f or electr ol yt e assess me nt ( pre-, 1, 2, 4, 6, 8 h) 
 Rec or di n g of c o m plia nce 
1 1. 1. 4  Bl o o d s a m pli n g visit ( Visit 4: D ay 1 5) 
D uri n g t his visit t h e f oll o wi n g assess me nt will be perf or me d: 
 Rec or di n g of c o n c o mita nt treat me nts 
 Rec or di n g of A Es 
 Bl o o d sa m pli n g f or electr ol yt e assess me nt ( 2 4 h) 
1 1. 1. 5  F- U a n d e arl y ter mi n ati o n visit ( Visit 5: Visit 2 2 d a ys) 
D uri n g t his visit t h e f oll o wi n g assess me nt will be perf or me d: 
 Rec or di n g of c o n c o mita nt treat me nts 
 Rec or di n g of A Es 
1 1. 2  Assess me nt d escri pti o ns  
1 1. 2. 1  S u bject De m o gr a p hy 
S u bject de m o gra p h y c o nsists of date of birt h, se x, h ei g ht a n d wei g ht. 
1 1. 2. 2  Me dic al Hist ory 
F or t he d o c u me ntati o n of t he me dical hist or y, a n y pre vi o us a n d c o n c o mita nt diseases 
wit hi n t he last 2 years bef ore scree ni n g will be d o c u me nte d i n t he C R F. 
T he me dical hist or y will b e o bt ai ne d b y as ki n g t he s u bject a n d b y i ns pecti n g his/ her 
me di cal re c or ds if a v aila bl e. 
F or statisti cal a nal ysis, all pre vi o us a n d c o nc o mita nt diseases will b e c o de d wit h Me dical 
Dicti o n ar y f or Re g ul at or y Acti vities ( Me d D R A), t he versi o n of w hi c h will be pr o vi de d i n 
t he tri al re p ort. 
1 1. 2. 3  Pre g n a ncy Test 
I n w o me n of c hil d beari n g p ote ntial, uri ne pre g n a nc y test will b e perf or m e d at scree ni n g. 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
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1 1. 2. 4  C o nc o mit a nt Me dic ati o n 
I nf or mati o n o n c o nc o mit a nt treat me nt will c o m prise all c o nc o mita nt t hera pies at t he 
M R E e xa mi n ati o n a n d u ntil t he e n d of treat me nt visit 2, bl o o d sa m pli n g. Acce pt a ble 
c o nc o mita nt treat m e nt o pti o ns are descri be d i n S ecti o n 1 0. 1 . 
1 1. 2. 5  Assess me nt of S afety 
A Es will b e rec or de d fr o m t he ti me of i nf or me d c o nse nt ( Da y 0) u ntil t h e f oll o w- u p visit 
or earl y ter mi nati o n visit. 
F or safet y reas o ns, s u bjects will b e c o ntacte d wit hi n 2 t o 4 d a ys after t h e M R E 
e xa mi nati o n b y t h e i n v esti gat or a n d as k e d a b o ut occ urre nce of a n y a d vers e e ve nt. N o 
ot h er f oll o w- u p is pla n ne d. 
Detail e d i nstr ucti o ns re g ar di n g A E ha n dli n g, m o nit ori n g a n d re p orti n g are pr o vi de d i n 
S ecti o n 0 ( A d vers e E ve nts).  
1 1. 2. 6  Electr olyte assess me nt 
Plas ma p otassi u m, s o di u m, p h os p h at e, a n d cal ci u m, as well as i o ni ze d calci u m bl o o d 
c o nce ntrati o n le vels will be m o nit ore d o ver 2 4 h o urs fr o m j ust bef ore ( bas eli n e) t he 
s u bj ect starts dri n ki n g L u m e nti n ®  4 4.  Bl o o d sa m ples will be dra w n at b aseli n e ( T 0 h), 
a n d t he n at 1 h o ur ( T 1 h), 2 h o urs ( T 2 h), 4 h o urs ( T 4 h), 6 h o urs ( T 6 h), 8 h o urs ( T 8 h) a n d 
at 2 4 h o urs ( T 2 4 h).  
A n I V a nte c u bital ca n n ula will b e place d f or pre- bl o o d sa m pl es a n d use d d uri n g t he first 
8 h i n cl u di n g a d mi nistrati o n of G d d uri n g t he M R E pr oce d ure. T hereafter it will b e 
discar de d. Bl o o d sa m pli n g o n t he f oll o wi n g da y after ( 2 4 h ti me p oi nt) will be dra w n 
wit h o ut a ca n n ula. 
Electr ol yt e bl o o d sa m pl es will be ta ke n, ha n dl e d, a n d a nal yse d acc or di n g t o st a n dar d 
pr oce d ur es at t he cli nic. T he la b orat or y will pr o vi d e n or mal ra n g es. 
1 1. 2. 7  M R E e x a mi n ati o n 
Pre parati o n bef ore M R E: S u bjects will be fasti n g ( 2 d ecilitres of cl ear w ater is all o we d) 
f or at least si x h o urs pri or t o t h e M R E pr oce d ure. 
T he M R E-e xa mi nati o n will ta ke a p pr o xi m atel y 4 0 mi n utes. T he M R-e xa mi nati o n will 
n ot b e perf or me d if t h e s u bject has n ot bee n a ble t o dri n k at least 1. 1 L of L u me nti n ®  4 4. 
Br oa dl y, M R E is a s ca n ni n g tec h ni q ue f or creati n g detaile d i ma ges of p arts of t he h u ma n 
b o d y, usi n g a str o n g ma g n etic fiel d a n d ra di o wa v es. It is base d o n t he ma g netisati o n 
pr o p erti es of at o mi c n uclei. A p o werf ul, u nif or m, e xter nal ma g n eti c fiel d is e m pl o ye d t o 
ali g n t he pr ot o ns t hat are n or mall y ra n d o ml y orie nte d wit hi n t h e water n u cl ei of t h e b o d y 
part e xa mi ne d. T his ali g n m e nt ( or ma g netisati o n) is disr u pt e d b y i ntr o d ucti o n of a n 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
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e xter nal Ra di o Fre q u e nc y ( R F) w a ve e ner g y. T h e n uclei ret ur n t o t heir resti n g ali g n me nt 
t hr o u g h vari o us rela xati o n pr ocesses a n d i n d oi n g s o e mit R F e ner g y. Tiss u es are 
c haracterise d b y t w o differe nt rela x ati o n ti mes, of w hic h T 1, t he l o n git u di n al rela xati o n 
ti me, det er mi nes t h e rate at w hic h e xcite d pr ot o ns ret ur n t o e q uili bri u m. It is a m eas ure of 
t he ti me ta ke n f or s pi n ni n g pr ot o ns t o reali g n wit h t he e xt er nal ma g n etic fi el d. T he 
c o ntrast a n d bri g ht n ess of t h e i ma ge are pre d o mi n at el y deter mi ne d b y T 1 pr o perties of 
tiss ue. 
D uri n g a n M R E-e x a mi nati o n, t he s u bject will b e as ke d t o lie pr o ne o n a m o va bl e ta bl e 
t hat will sli de i nt o a d o u g h n ut-s h a pe d, d ee p o pe ni n g a n d ce ntre d f or s ca n ni n g t he s mall 
b o wel. As part of t h e pr oce d ure a str o n g ma g netic fiel d will be ge ner at e d ar o u n d t he 
s u bj ect, a n d p ulsati n g ra di o wa ves will be direct e d at t h e b o d y. Beca us e of l o u d t h u m pi n g 
a n d ta p pi n g n oises d uri n g t h e sca n t he s u bject will be gi v e n hea d p h o n es t o list e n t o m usic 
or ear pl u gs t o hel p bl o c k t h e s o u n d. T he s u bject will be a ble t o c o m m u nicate wit h t h e 
tec h ni ci a n w h o gi v es i nstr ucti o ns d uri n g t h e test. T he c o ntrast a g e nt Claris ca n®  ( 0. 1 
m m ol/ k g) a n d t he m uscle rela xa nt B usc o pa n ®  ( 4 0 m g) (t o re d uce b o wel m otilit y) will be 
a d mi nistere d I V. Clarisca n a n d B usc o pa n ca n be re place d  wit h c o m para ble pr o d uct 
acc or di n g t o t h e sta n d ar dise d pr oce d ures at t he cli ni c. T he s pecific details of t h e M R E-
s yste m use d will be n ote d i n t h e C R F.  
1 1. 3  O utc o me assess me nts 
1 1. 3. 1  Pri m ary o ut c o mes 
All M R E i m a ges will be e val uate d b y o ne e x p ert ra di ol o gist. O nl y o ne assess me nt of 
eac h M R E e x a mi nati o n will be perf or me d.  
T he pri mar y e n d p oi nt is t he vis ual e val uati o n of t h e M R E i ma ges acc or di n g t o t he 
f oll o wi n g p ara meters:  
 
M otilit y: M R E e xa mi nati o ns wit h L u me nti n
®  4 4 will be sc ore d wit h res pect t o m otilit y 
stat us base d o n a 5- gra de d scale, as f oll o ws: 
1.  N o m otilit y c o ul d b e assesse d 
2.  M otilit y is assesse d t o s o me d e gree b ut less g o o d t h a n c o n ve nti o nal M R E 
3.  M otilit y is assesse d t o sa me de gree as c o n v e nti o nal M R E 
4.  M otilit y is assesse d s o me w hat b etter t ha n c o n v e nti o nal M R E 
5.  M otilit y is assesse d better t ha n c o n ve nti o nal M R E 
M otilit y s h o ul d be e v al u ate d as a w h ol e i n t h e s pe cific ci ne- se q ue n ces a n d res ulti n g 
i n o n e or di nal sc ore 1- 5. 
Artef a cts: M R E e xa mi n ati o ns wit h L u me nti n
®  4 4 will be sc ore d wit h res pect t o artefacts 
base d o n a 5- gra d e d scale, as f oll o ws:  


S p o ns or: L u me nt A B  
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Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
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1.  S e vere det eri orati n g artefacts i n t he i nterfa ce b et w ee n t he l u me n a n d wall 
2.  Dist ur bi n g artefacts i n t he i nterface b et wee n t he l u me n a n d wall l ess g o o d 
c o m pare d t o c o n v e nti o nal M R E 
3.  Me di u m artefacts i n t h e i nterfa ce bet w ee n t h e l u m e n a n d wall, sa me as f or 
c o n v e nti o nal M R E 
4.  S mall artefacts t hat gi ve mi ni m al bri g ht e d ges i n t h e i nterface bet wee n t he l u me n 
a n d wall, s o me w h at better t h a n c o n ve nti o nal M R E 
5.  N o art efacts a n d b etter t ha n c o n v e nti o nal M R E 
Artefacts s h o ul d be e v al u ate d as a w h ol e i n all se q ue nces a n d res ulti n g i n o ne or di nal 
sc ore 1- 5. 
M uc os al e v al u ati o n: M R E e xa mi nati o ns wit h L u me nti n
®  4 4 will be sc ore d wit h res pect 
t o m u c osal stat us bas e d o n a 5- gra d e d scale, as f oll o ws: 
1.  N o m uc osal f ol ds are see n 
2.  S o me s mall m u c osal f ol ds ca n be discri mi n ate d 
3.  M u c osal f ol ds ca n b e discri mi n ate d, sa me as f or c o n ve nti o nal M R E 
4.  S mall m u c osal f ol ds ca n be discri mi nate d, s o me w h at b etter t ha n f or c o n ve nti o nal 
M R E 
5.  M u c osal f ol ds are see n i n d etail a n d better t ha n c o n v e nti o nal M R E 
M uc osal e val uati o n a) c or o n al a n d b) a xial T 1 gra di e nt-ec h o wit h G d s h o ul d be d o n e a n d 
res ulti n g i n o ne or di n al sc ore 1- 5. 
O v er all di a g n ostic i m pressi o n: M R E e xa mi nati o ns wit h L u me nti n
®  4 4 will be gra de d 
f or gl o bal q ualit y of t h e i nf or mati o n o btai n e d wit h s pecial refere nce t o dia g n ostic 
p ur p oses, as f oll o ws: 
1.  P o or dia g n ostic q u alit y 
2.  Me di u m dia g n osti c q ualit y, bel o w c o n v e nti o nal M R E 
3.  G o o d dia g n osti c q ualit y, sa me as f or c o n ve nti o nal M R E 
4.  Ver y g o o d dia g n ostic q u alit y, s o me w hat better t ha n c o n ve nti o nal M R E 
5.  E xcelle nt dia g n osti c q ualit y, better t ha n c o n v e nti o nal M R E 
T he q ualit y of t he w h ole e xa mi nati o n a n d w hat t h e i m pressi o n is f or usi n g t he 
e xa mi nati o n f or dia g n osti c p ur p oses will be gra d e d. 
1 1. 3. 2  S ec o n d ary o utc o mes 
Electr ol yte c h a n g es: C ha n ges i n electr ol ytes i n t h e bl o o d of eac h s u bj ect will b e 
e val uate d b y c o m p ari n g basel Plas ma c o nc e ntrati o n was meas ur e d o v er 2 4 h fr o m b ef ore 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
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a d mi nistarti o n of L u me nti n 4 4 ( T 0 h) t 0 2 4 h o urs p ost a d mi nistrati o n ( T 2 4 h) i n e ( pre- 
L u me nti n ®  4 4 oral i nt a ke) a n d ti me p oi nts u p t o 2 4 h o urs p ost L u me nti n®  4 4 oral i nt a ke.  
B o wel filli n g p r o p erties: E xte nsi o n a n d diste nsi o n will be e val uate d i n e ac h of fi ve 
selecte d s u b-se g me nts of t h e s mall b o wel. All i ma g es will be e val uate d b y t h e 
i n v esti g at or wit h res p ect t o h o w well t h e s mall b o wel is fille d fr o m t h e b o wel t hr o u g h t o 
t he ter mi n al ile u m (e xt e nsi o n) a n d h o w well it is dist e n de d ( diste nsi o n) b y L u me nti n®  4 4. 
T he s m all b o wel will be di vi de d i n d u o d e n u m, jej u n u m, pr o xi mal il e u m, distal ile u m a n d 
ter mi n al ile u m. B ot h v aria bles will b e j u d ge d o n a scal e fr o m 1 t o 5, as f oll o ws: 
 E xte nsi o n: 1 is n o filli n g a n d 5 is fille d c o m pletel y 
 Dist e nsi o n of t he se g me nt of s mall b o wel:  1 is n o diste nsi o n a n d 5 is o pti mal 
diste nsi o n 
 
S afet y o utc o mes: All a d verse e v e nts i n t his st u d y will b e c ollecte d a n d pr o cesse d i n 
acc or d a nce wit h I C H- G C P a n d n ati o nal a n d l ocal la ws a n d r e g ulati o ns. I n li ne wit h t hese, 
t he I n v esti g at or is res p o nsi ble f or re p orti n g S eri o us A d verse E v e nts ( S A Es) t o S p o ns or 
wit hi n t he a p pr o priate ti meli nes. If re q uire d, t h e I n vesti g at or is als o res p o nsi ble f or 
n otif yi n g t he a p pr o pri ate l o cal et hics c o m mittee of S A Es per t he g ui deli nes of t h e 
I nstit uti o n a n d i n acc or da nce wit h af ore me nti o ne d la ws a n d re g ul ati o ns. Det aile d 
descri pti o n o n ha n dli n g, m o nit ori n g a n d re p orti n g A Es is pr o vi de d i n S ecti o n 0 .   
 
 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
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1 5 t h N o ve m ber 2 0 2 2 
1 2  A D V E R S E E V E N T S 
A n y u nt o war d me di cal o cc urre nce i n a s u bj ect or cli nical trial s u bject a d mi nistere d a 
me di ci nal pr o d uct a n d w hi c h d o es n ot necess aril y h a ve a ca usal rel ati o ns hi p wit h t his 
treat me nt. U nt o war d me dical o cc urre n ces occ urri n g pri or t o t he M RI/ M R E assess me nt 
will n ot be re p orte d as a n a d verse e ve nt. All A Es o cc urri n g t hr o u g h o ut t h e trial will be 
rec or d e d a n d f oll o w e d.  
C o m me nt:  A n A E ca n t h eref ore be a n y u nfa v o ura ble a n d u ni nte n de d si g n (i n cl u di n g a n 
a b n or mal l a b orat or y fi n di n g), s y m pt o m, or disease te m p orall y ass ociat e d wit h t h e us e of 
a n I M P, w het her or n ot c o nsi d ere d rel at e d t o t he I M P. 
1 2. 1. 1  A dverse Re acti o n 
All u nt o war d a n d u ni nte n de d res p o nses t o a n i n v esti gati o nal me di ci nal pr o d uct relate d t o 
a n y d ose a d mi nistere d. 
C o m me nt:  All A Es j u d ge d b y eit h er t h e re p orti n g I n v esti gat or or t he S p o ns or as h a vi n g a 
reas o na bl e ca us al relati o ns hi p t o a me dici nal pr o d uct q u alif y as a d v erse reacti o ns. T he 
e x pressi o n reas o n a ble ca usal relati o ns hi p mea ns t o c o n ve y i n g e neral t hat t h ere is 
e vi de nce or ar g u m e nt t o s u g gest a ca us al relati o ns hi p. 
1 2. 1. 2  U ne x pect e d A dverse Re a cti o n 
A n a d vers e reacti o n, t he nat ure or se v erit y of w hic h is n ot c o nsiste nt wit h t he a p pli ca ble 
pr o d uct i nf or mati o n (e. g., I B f or a n u na ut h orise d I P or s u m mar y of pr o d uct 
c haracteristics f or a n a ut h orise d pr o d uct). 
C o m me nt:  W he n t he o utc o me of t he a d v erse reacti o n is n ot c o nsist e nt wit h t he a p plica ble 
pr o d uct i nf or mati o n t his a d v erse reacti o n s h o ul d be c o nsi dere d as u ne x p ect e d. 
1 2. 1. 3  S eri o us A d verse Eve nt 
A n y u nt o war d me di ci nal occ urre nce or effect t h at at a n y d ose: 
 Res ults i n deat h 
 Is life-t hreate ni n g 
 Re q uires h os pitalisati o n or pr ol o n gati o n of e xisti n g h os pitalisati o n 
 Res ults i n persiste nt or si g nifica nt disa bilit y or i nca pacit y 
 Is a c o n ge nital a n o mal y or birt h defect 
C o m me nts: Life-t hreate ni n g i n t he defi niti o n of a n S A E or seri o us a d verse reacti o n refers 
t o a n e ve nt i n w hic h t he s u bject was at ris k of deat h at t he ti me of e ve nt; it d oes n ot refer 
t o a n e ve nt w hi c h h y p ot h eticall y mi g ht ha ve ca us e d deat h if it was m ore s e v ere. 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
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Me dical j u d ge me nt s h o ul d be e xercise d i n d eci di n g w het h er a n A E/reacti o n is seri o us i n 
ot h er sit u ati o ns. I m p orta nt A Es/reacti o ns t hat are n ot i m m e di atel y life-t hreate ni n g or d o 
n ot res ult i n deat h or h os pit alisati o n b ut ma y je o par dise t h e s u bj ect or ma y re q uire 
i nter ve nti o n t o pre v e nt o ne of t he ot her o ut c o mes liste d i n t he defi niti o n a b o ve, s h o ul d 
als o be c o nsi d ere d seri o us. 
1 2. 2  Re p orti n g of A d verse E v e nts 
All trial s u bjects will b e caref ull y m o nit ore d f or t he occ urre n ce of A Es d uri n g t h e trial 
peri o d, fr o m start of i nta ke of t h e first d ose of c o ntrast a ge nt u ntil t he f oll o w- u p visit. 
Als o, tele p h o ne i nter vie ws will b e ma de 2 d a ys after M R E assess me nt t o i n vesti gate if 
a n y A Es o cc urre d d uri n g t he first da ys after t h e e xa mi nati o n. A n y pre g na ncies occ urri n g 
i n t he s a me trial p eri o d will be re p orte d a n d f oll o we d.  
Re p ort e d A Es will be f oll o we d u p (see Se cti o n 1 2. 5 bel o w). T he I n vesti gat or will c ollect 
A Es wit h a n o n-lea di n g q uesti o n s uc h as “ ha v e y o u e x perie nce d a n y n e w h ealt h pr o ble ms 
or w orse ni n g of e xisti n g c o n diti o ns” as well as re p orti n g e ve nts directl y o bser ve d or 
s p o nta ne o usl y v ol u nteere d b y s u bjects. 
Clearl y rel ate d si g ns, s y m pt o ms a n d a b n or mal dia g n ostic pr o ce d ure res ults s h o ul d be 
gr o u pe d t o get her a n d re p orte d as a si n gle dia g n osis or s y n dr o me w he n e ver p ossi ble. 
All A Es i ncl u di n g b ut n ot li mit e d t o e ve nts re p orte d b y t he s u bject, or re p orte d i n a ns wer 
t o a n o pe n q uesti o n b y t he I n vesti gat or or m e m ber of t his tea m, w hi c h fall i nt o a n y of t he 
a b o v e d efi niti o ns m ust be rec or de d as a n A E i n t h e C R F a n d s h o ul d i ncl u d e t he f oll o wi n g 
i nf or mati o n: 
 Brief descri pti o n of t he e ve nt ( dia g n osis) 
 Start date (a n d ti me, if r el e va nt) 
 St o p date (a n d ti me, if rele va nt) 
 S e verit y 
 Acti o n ta ke n re gar di n g trial treat me nt 
 O pi ni o n o n ca usalit y 
 S eri o us ness 
 O utc o me 
A Es will b e c o de d wit h M e di cal Dicti o n ar y f or R e g ul at or y Acti vities ( Me d D R A), t he 
versi o n of w hi c h will be pr o vi de d i n t he trial re p ort. 
1 2. 2. 1  S everity 
S e verit y descri b es t h e i nte nsit y of a n e ve nt, a n d will be assesse d as: 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
3 8 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
Mil d : T h e A E d oes n ot i nt erfere i n a si g nifica nt ma n ner wit h t h e s u bject’s n or mal 
f u ncti o ni n g le vel. It ma y be a n a n n o y a nce. 
M o der ate:  T he A E pr o d u ces s o me i m pair me nt of f u ncti o n b ut n ot hazar d o us t o h ealt h. It 
is u nc o mf orta ble a n d/ or a n e m barrass me nt. 
S e vere:  T h e A E pr o d uces si g nifica nt i m pair me nt of f u ncti o ni n g or i n ca pacitati o n a n d/ or 
it is a hazar d t o t he s u bj ect. 
If a n A E c ha n ges i n s e verit y, t he w orst se verit y s h o ul d b e re p orte d. 
1 2. 2. 2  C a us ality 
Ca usalit y will be assesse d as: 
Pr o b a ble: A cli ni cal e ve nt, i n cl u di n g la b orat or y test a b n or malit y, wit h a reas o n a bl e ti me 
se q u e nce t o a d mi nistrati o n of t h e dr u g, u nli kel y t o be attri b ut e d t o c o n c urre nt disease or 
ot h er dr u gs or c h e micals, a n d w hic h f oll o ws a cli nicall y reas o n a ble res p o ns e o n 
wit h dra wal ( dec halle n g e). Rec halle n ge i nf or mati o n is n ot re q uire d t o f ulfil t his defi niti o n. 
P ossi ble: A cli ni cal e ve nt, i n cl u di n g la b orat or y test a b n or malit y, wit h a reas o n a bl e ti me 
se q u e nce t o a d mi nistrati o n of t h e dr u g, b ut w hi c h c o ul d als o be e x plai ne d b y c o nc urre nt 
disease or ot her dr u gs or c he mi cals. I nf or mati o n o n dr u g wit h dra wal ma y b e lac ki n g or 
u nclear. 
U nli k el y: A cli ni cal e ve nt, i n cl u di n g la b orat or y test a b n or malit y, wit h a te m p oral 
relati o ns hi p t o dr u g a d mi nistrati o n w hic h ma kes a ca usal relati o ns hi p i m pr o ba ble, a n d i n 
w hic h ot her dr u gs, c he micals or u n derl yi n g disease pr o vi de pla usi ble e x pla nati o ns. 
1 2. 3  F oll o w- u p of S u bj ects after A d verse E ve nts 
A Es t hat are s eri o us or t h ose t h at t he i n vesti gat or assesses as rele va nt t o f oll o w fr o m a 
trial pers pecti v e will be f oll o we d u ntil t he y are rec o vere d, st a bilis e d, or rec o vere d wit h 
se q u elae. T h e date a n d o utc o me will b e rec or de d o n t h e A E f or m i n t h e C R F. Ot h er 
o n g oi n g A Es will n ot be f oll o we d wit hi n t he trial after t he d ate of t he f oll o w- u p visit. 
1 2. 4  A b n o r m al L a b o r at or y V al ues 
Ot h er t ha n electr ol ytes, s afet y l a b orat or y para met ers will n ot be assesse d i n t his trial. 
1 2. 5  Re p orti n g of Seri o us A d v ers e E v e nts 
T he I n vesti g at or is res p o nsi ble f or e ns uri n g t h at all S A Es are re p orte d t o t he S p o ns or 
i m me diatel y, b y e- mail ( preferre d) or f a x, b ut i n a n y e ve nt n o l ater t h a n  2 4 h o urs of a n y 
site staff bec o mi n g a ware of t he e v e nt. All A Es t h at meet t he criteria f or S A E re q uire t he 
c o m pleti o n of a st u d y s pecific S A E F or m ( or A d diti o nal S afet y I nf or mati o n ( A SI) F or m). 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
3 9 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
T his a p plies t o all S A Es, w het her t he y were c o nsi dere d t o be rel at e d t o t he st u d y 
treat me nt or n ot.  
T he f oll o wi n g i nf or mati o n is m a n d at or y  f or t he i nitial re p ort: 
 S u bject trial i de ntificati o n data (I D) 
 Trial treat me nt 
 Start date (ti me, if rele v a nt) of t h e trial treat m e nt 
 Brief descri pti o n of t he e ve nt ( dia g n osis) 
 Start date (ti me, if rele v a nt) of t h e e ve nt 
 S eri o us ness criteria 
 Ca usalit y assess me nt 
T he I n vesti g at or m ust re p ort all S A Es t o S p o ns or i m m e di at el y, i. e., wit hi n 2 4 h o urs ( via 
e mail or fa x) of lear ni n g of its occ urre nce. F or t his re p orti n g, a n S A E F or m ( pr o vi d e d i n 
t he I n v esti g at or File) nee ds t o b e c o m pl et e d. F oll o w- u p i nf or mati o n a b o ut a pre vi o usl y 
re p orte d S A E m ust als o b e re p ort e d t o S p o ns or wit hi n 2 4 h o urs of recei vi n g t he 
i nf or mati o n. T his f oll o w- u p data m ust be pr o vi de d o n a n A SI F or m.  
If a S A E o cc urre d aft er si g ni n g i nf or me d c o nse nt, b ut bef ore st u d y treat me nt a n d t he 
s u bj ect c o nti n ues o n st u d y, a S A E m ust als o b e e nt ere d o n t h e rele va nt M e dical Hist or y 
pa ge of t he C R F. 
T he S A E re p ort s h o ul d pr o vi de a detaile d d escri pti o n of t he A E a n d s h o ul d i n cl u de 
a n o n y mise d c o pies of h os pit al rec or ds a n d ot h er rele va nt d o c u me nts.  
All S A Es will nee d t o be f oll o we d acti vel y u ntil res ol uti o n or sta bilisati o n. T he a b o v e is 
als o a p pli ca ble t o f oll o w- u p S A E i nf or mati o n. 
T he S p o ns or is res p o nsi ble f or i nf or mi n g t he C o m pete nt A ut h orities, t h e E ur o pea n 
Me dici nes A ge nc y ( E M A) a n d Et hics C o m mitt ees of a n y i n di vi d ual case re p orts of S A Es 
t hat are d eter mi n e d t o be re p ort a ble b y t h e s p o ns or (i.e., a d v erse e ve nts c o nsi dere d as 
seri o us u ne x pecte d s us pecte d a d v erse reacti o ns [ S U S A Rs]). S U S A Rs will b e distri b ute d 
b y t h e S p o ns or’s p h ar mac o vi gila nce tea m wit hi n 7- 1 5 w or ki n g d a ys t o t h e E M A 
( E u dra Vi gila nc e) a n d c o ncer n e d C o m pete nt A ut h oriti es a n d Et hi cs C o m mittees, 
acc or di n g t o l o cal re g ulati o ns. T h e i n vesti g at or will be n otifie d of safet y iss ues / S U S A Rs 
acc or di n g t o c urre nt le gislati o n. 
T he s p o ns or is re q uire d b y la w t o re p ort t o t h e healt h a ut h oriti es i n a writte n safet y 
re p ort: 1) all fatal or life-t hreate ni n g S U S A Rs wit hi n s e ve n ( 7) cale n dar da ys of i nitial 
n otificati o n; a n d 2) all ot her S U S A Rs wit hi n fiftee n ( 1 5) cale n d ar d a ys of i nitial 
n otificati o n. 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
4 0 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 2. 6  Prec a uti o ns/ O ver d ose 
Ris ks ass o ciate d wit h i nt a ke of oral c o ntrast a ge nts i n cl u de d ys p ha gia wit h as pirati o n a n d 
sec o n d ar y p n e u m o nia. Alt h o u g h pati e nts wit h ac ute pr o ble ms are e xcl u de d, a pre-
e mer ge n c y s mall b o wel stat us mi g ht be a g gra vate d t o a n esta blis h e d ile us b y i n g esti n g a 
lar ge v ol u me. Oral c o ntrast a ge nts s h o ul d n ot b e gi ve n t o s u bc o nsci o us p atie nts, t o t h ose 
wit h s wall o wi n g dis or ders, or a n ac ute a b d o me n.  
K n o w n se nsiti vit y or aller g y t o c o ntrast a ge nt i n gre die nts are e xcl usi o n crit eria i n cli ni cal 
st u dies. H o we ver, u n k n o w n se nsiti vities or aller gies mi g ht ca use reacti o ns t h at ma y nee d 
t o be me dicall y treat e d.  
I ntra ve n o usl y a d mi nist ere d G d m a y c a use aller gi c reacti o n of v ari o us se verit y fr o m a 
mil d r us h t o i nt e nsi v e care u nit treat me nt. T his is es peciall y tr ue f or t h ose wit h all er gi c 
reacti o ns t o a c o ntrast a g e nt earlier i n life. Aller gic reacti o n ma y be tri g ge d i n t h ose wit h 
ast h matic br o nc hitis a n d treate d wit h bet a- bl oc kers. R o uti nes f or ha n dli n g t hese cases are 
well k n o w n t o t h e staff w hic h is re g ul arl y trai n e d i n d eali n g wit h e mer ge n c y cases. 
E q ui p me nt f or e mer ge nc y care treat m e nt is a v aila ble at t he cli ni c a n d t he cli ni c is l ocate d 
i n cl ose pr o xi mit y t o t h e h os pit al e mer ge nc y car e de part me nt. Neit her i o di ne n or G d 
s h o ul d be a d mi nistere d t o p atie nts wit h se vere ki d ne y fail ure.  
 
 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
4 1 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 3  S T A T I S T I C A L M E T H O D S 
1 3. 1  Ge ner al st atisti c al c o nsi der ati o ns 
N o statistical t ests will be c o n d ucte d. C o nfi d e nce i nter vals ma y be c o nstr u ct e d a n d will 
t he n be 2-si de d a n d of 9 5 % c o nfi de n ce.  
C o nti n u o us data will be s u m marise d usi n g descri pti ve statisti cs ( N, mea n, me dia n, 
sta n dar d d e viati o n, mi ni m u m a n d ma xi m u m). C ate g orical data will be s u m marise d b y 
fre q ue n c y ta bl es ( n u m b ers a n d perce nt a ges).  
U nless ot her wise state d, all a nal yses will be d o n e o n o bser ve d cases wit h o ut a n y 
s u bstit uti o n of missi n g val ues. 
1 3. 2  S a m ple Si ze  
A t ot al of 1 0 f ull y e val ua ble h ealt h y v ol u nteers will be i n cl u de d i n t he trial. T h e n u m ber 
of s u bj ects is c o nsi dere d t o b e e n o u g h t o dra w cli nical c o ncl usi o ns a n d is n ot base d o n 
a n y mat he matical gr o u n ds. 
1 3. 3  A n al yses Sets 
All s u bjects w h o ha ve f ulfill e d t he trial will be i n cl u de d i n t he statistical e val u ati o n.  
1 3. 4  Descri pti o n of St atistic al A n al yses 
A c ollecte d d ata will be s u m marise d usi n g descri pti ve statisti cs a n d c o nfi de nce i nter vals. 
N o statistical t ests are pla n ne d t o be c o n d u ct e d. 
1 3. 5  D at a c ollecti o n 
T he d ata i n t his trial will be rec or de d o n pa per C R Fs, as per data ma n a ge m e nt a n d q ualit y 
ass ura n ce pr oce d ures des cri b e d i n S ecti o n 0 . W he n t he data o n t he C R Fs h as b ee n 
verifie d ( b y t h e st u d y m o nit or) a gai nst s o urce data t he y will b e se nt f or data e ntr y. All 
C R Fs will be si g ne d b y t he pri n ci p al i n vesti g at or. 
Data e ntr y will b e c o n d u cte d usi n g t h e v erifie d C R Fs as s o urce. All data e ntr y will be 
c o ntr oll e d usi n g pr o of rea di n g. 
W he n data fr o m all s u bje ct’s C R Fs are e nt er e d i nt o t he data base a clea n fil e meeti n g will 
be h el d. At t h at meeti n g it will be deci d e d if a n y of t h e s u bj ects s h o ul d b e e xcl u de d fr o m 
statistical a nal ysis. 
W he n it has bee n d eci de d w hic h s u bjects s h o ul d be i n cl u de d i n t h e data a nal yses, t h e trial 
data base will be l o c k e d a n d a c o p y of t he it will be se nt f or st atisti cal a nal yses. 
 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
4 2 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
 
1 4  E T H I C S 
1 4. 1  I n de pe n de nt Et hics C o m mittee (I E C) 
T he cli nical trial m ust b e a p pr o ve d b y/recei v e fa v o ura ble o pi ni o n fr o m rele va nt 
I n d e pe n de nt Et hics C o m mittees (I E Cs) pri or t o e nr ol me nt of s u bjects. 
A n y a me n d me nts t o t he a p pr o ve d cli ni cal tri al m ust li ke wise, as re q uire d, be a p pr o ve d 
b y/recei v e fa v o ura ble o pi ni o n fr o m rel e va nt I E Cs pri or t o i m ple me ntati o n. 
T he a p pr o priate r e g ulat or y a ut h orit y(i es) m ust b e n otifie d of/a p pr o ve t he cli nical tri al, as 
re q uire d. 
1 4. 2  Et hic al C o n d uct of t he Tri al 
T his cli nical st u d y was d esi g ne d a n d s hall be i m ple me nte d a n d re p orte d i n acc or d a nc e 
wit h t h e pr ot o c ol, et hical pri nci ples lai d d o w n i n t he Decl arati o n of H elsi n ki a n d t he 
I nter nati o nal C o nfere n ce o n H ar m o nizati o n (I C H) Har m o nize d Tri partite G ui deli nes f or 
G o o d Cli nical Practice ( G C P).  
If a n y c h a n g es t o t he pr ot oc ol are re q uire d, t he pr ot o c ol m ust be a me n de d (see Secti o n 
1 6. 2 ).  
1 4. 3  S u bject I nf or m ati o n a n d C o nse nt 
All s u bjects will recei ve writte n a n d ver b al i nf or mati o n re gar di n g t he trial b ef ore a n y 
trial-relate d pr oce d ures are perf or me d. T his i nf or mati o n will e m p h asise t h at partici pati o n 
i n t he trial is v ol u ntar y a n d t hat t h e s u bj ect ma y wit h dra w fr o m t h e tri al at a n y ti me a n d 
f or a n y reas o n. All s u bjects will be gi ve n t he o p p ort u nit y t o as k q u esti o ns a b o ut t he trial 
a n d will be gi v e n s ufficie nt ti me t o deci de w het her t o p arti ci pate i n t h e trial. 
T he p atie nt’s si g ne d a n d date d i nf or m e d c o nse nt t o partici p at e i n t he trial will be o btai n e d 
p ri or  t o a n y trial relat e d pr oce d ure is bei n g carrie d o ut. T he c o nse nt f or m m ust als o b e 
si g n e d b y t h e pers o n w h o c o n d uct e d t he i nf or me d c o nse nt disc ussi o n 
T he c o nse nt i ncl u d es i nf or m ati o n t hat dat a will be rec or de d, c ollecte d, pr o cesse d a n d 
ma y be tra nsf err e d t o E ur o pea n Ec o n o mic Area ( E E A) or n o n- E E A c o u ntri es. I n 
acc or d a nce wit h t he E U ge neral d ata pr ote cti o n re g ulati o n 2 0 1 6/ 6 7 9 ( G D P R), t he d ata 
will n ot i de ntif y a n y pers o ns ta ki n g part i n t h e tri al. 
A c o p y of t he s u bje ct i nf or mati o n i ncl u di n g t he si g ne d i nf or me d c o ns e nt f or m will be 
pr o vi d e d t o t h e s u bject, f or t heir rec or ds. 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
4 3 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 4. 4  S u bject D at a Pr otecti o n 
All i nf or mati o n c o ntai ni n g pers o nal d ata will be h a n dle d i n acc or da n ce wit h S w e dis h 
data pr ot ecti o n l e gisl ati o n a n d wit h t he E U ge neral d ata pr otecti o n re g ulati o n 2 0 1 6/ 6 7 9 
( G D P R). 
1 4. 5  Ot her Et hi c al a n d Re g ul at or y Iss u es 
If a si g nifica nt safet y iss u e is i de ntifi e d, eit h er fr o m a n i n di vi d u al case re p ort or re vie w of 
a g gre gat e d ata, t he n t h e S p o ns or will iss u e pr o m pt n otificati o n t o all parties: Re g ulat or y 
A ut h orities, I n vesti gat ors a n d I E Cs. 
A si g nifica nt safet y iss ue is o ne t hat h as a si g nifica nt i m p act o n t h e c o urs e of t he cli nical 
trial or pr o gra m (i n cl u di n g t he p ot e nti al f or s us pe nsi o n of t h e trial pr o gra m or 
a me n d me nts t o pr ot o c ols) or warra nts i m m e diate u p date of i nf or me d c o nse nt. 
1 4. 6  Et hic al C o nsi der ati o n st ate me nt 
O ur n e wl y i n ve nte d p er oral a ge nt f or b o w el filli n g pri or t o C T or M R E of t h e a b d o me n 
has re veale d a g o o d p ot e ntial t o i m pr o v e i ma gi n g of t h e b o wel w all i n c o m paris o n t o 
c urre ntl y use d c o ntract i ma gi n g a ge nts. I n a d diti o n, bei n g a bl e t o use t he s a me a ge nt f or 
b ot h t h ese pr oce d ures will offer o p erati o nal be n efits t o dia g n ostic cli ni cs. 
P ote ntial b e nefits f or f ut ure p atie nts i n cl u de first a n d f ore m ost M R E i m a g es easier t o 
i nter pret, t h er e b y facilitati n g dia g n ostics of earl y a n d hit hert o sile nt disease, a n d re d uci n g 
t he ris k of misrea di n g. Sec o n dl y, ris ks of a d v erse effects are li kel y t o be n ota bl y l o w as 
o ur ne w a ge nt is f o o d- base d wit h 4 4 % v/ v air i n water, 2 % e g g w hite pr ot ei n, less t h a n 
1 % b uffer a ge nt, a n d less t ha n 1 % f oa m sta bilizer a n d taste i m pr o vi n g a d diti v es. 
 
 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
4 4 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 5  D A T A M A N A G E M E N T A N D Q U A L I T Y A S S U R A N C E 
1 5. 1  Q u alit y Ass ur a nce 
T he S p o ns or or desi g n ee will c o n d uct a sit e visit t o verif y t he q ualificati o ns of t he 
I n v esti gat or, i ns pect t h e site facilities, a n d i nf or m t he I n vesti gat or of res p o nsi bilities a n d 
t he pr oce d ures f or e ns uri n g a de q uate a n d c orrect d oc u me ntati o n. 
T he I n vesti g at or is re q uire d t o pre pare a n d m ai ntai n a de q uat e a n d acc urate case hist ories 
desi g ne d t o rec or d all o bser vati o ns a n d ot her data p erti ne nt t o t he trial f or e ac h trial 
partici pa nt. All i nf or mati o n rec or de d o n t h e C R Fs f or t his trial m ust, if a p pli ca ble, be 
c o nsiste nt wit h t he s u bjects’ s o urce d o c u me ntati o n (i. e., me dical rec or ds). 
Trial sit es, facilities, la b orat ories a n d all data (i ncl u di n g s o urces) a n d d o c u me ntati o n 
m ust b e a vaila bl e f or G C P a u dit b y L u me nt A B or i ns pecti o n b y c o m pet e nt a ut h oriti es. 
A n y as pect of t he trial ma y b e s u bject t o a u dit b y L u me nt A B a n d/ or i ns p ecti o n b y 
re g ul at or y a ut h orities or I E C. S uc h a u dits/i ns pecti o ns ma y ta ke place at t h e s p o ns or’s 
site(s) or at a n y trial site i ncl u di n g la b orat ories, p har macies etc. 
T he m o nit or will, i n case of a u dit, a n n o u nce t his i n a d va nce t o t he i n vesti gat or a n d b e 
prese nt at t h e p artic ular trial site d uri n g t he a u dit. 
T he sit e staff s h o ul d assist i n all as pects of a u dit/i ns pecti o n. 
1 5. 2  Tri al M o nit ori n g 
L u me nt A B, as s p o ns or of t his cli nical trial, is res p o nsi ble t o t he re g ulat or y a ut h orities f or 
ass uri n g t he pr o per c o n d uct of t h e cli nical trial wit h re g ar d t o pr ot oc ol a d here nce a n d 
vali dit y of t he data rec or de d i n t he C R Fs. T he c o m pa n y has t h eref ore assi g ne d a C R O t o 
m o nit or t his trial. T heir d uties are t o ser v e as t he pri nci pal li n k bet wee n i n v esti gat ors a n d 
L u me nt A B a n d a d vise t he i n vesti gat or o n t h e c ollecti o n a n d mai nte na nce of attri b uta bl e, 
le gi ble, c o nte m p ora n e o us, ori gi n al a n d acc urate d ata f or t he tri al. I n a d diti o n, t he y will 
e x plai n t o t h e i n vesti gat ors a n y as p ect of t h e (c o n d uct of t he) trial, i n cl u di n g 
i nter pretati o n of t h e pr ot oc ol, t h e p ur p ose of c ollecti n g t h e s pecifie d data a n d re p orti n g 
res p o nsi bilities. 
T he m o nit or will visit t h e tri al sit es bef ore, d uri n g a n d after t h e trial t o e ns ure t hat t he 
trial is c o n d ucte d a n d d o c u me nte d i n acc or da nce wit h t his pr ot oc ol, I C H G C P g ui deli nes, 
re g ul at or y r e q uire me nts, a n d a n y trial s pecific d oc u me nts s u c h as C R F c o m pleti o n 
g ui deli nes. 
M o nit ori n g visits will be c o n d ucte d t o c o nfir m t hat e. g.: 
 T he ri g hts a n d well- b ei n g of h u ma n s u bjects are pr ot ect e d 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
4 5 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
 T he i n vesti gati o nal tea m is a d heri n g t o t h e trial pr ot oc ol 
 I nf or me d c o ns e nt has bee n o btai n e d fr o m all partici pa nts 
 A Es ha ve b ee n re p orte d as re q uire d 
 Data are bei n g acc uratel y rec or de d i n t he C R Fs a n d are i n acc or d a nce wit h 
s o urce data 
 I P is bei n g st ore d c orrectl y a n d dr u g acc o u nta bilit y is bei n g perf or me d o n a n 
o n- g oi n g basis 
 I P is gi v e n t o c orrect s u bject 
 Facilities ar e, a n d re mai n, acc e pta bl e t hr o u g h o ut t he trial 
 T he I n vesti g at or a n d t he site are recei vi n g s ufficie nt i nf or mati o n a n d s u p p ort 
t hr o u g h o ut t h e trial 
T he C R F data will be m o nit ore d o n at re g ular i nter vals. T h e m o nit ori n g will i n cl u de 
s o urce data v erifi cati o n ( S D V) acc or di n g t o t he S D V list a n d verifi cati o n of data 
c o nsiste nc y o ver ti me. T he I n vesti g at or a n d ot her rele va nt trial p ers o n n el s h o ul d be 
a vaila bl e d uri n g t h e m o nit ori n g visits. 
I n or der t o perf or m t heir r ole effecti vel y, m o nit ors a n d pers o ns i n v ol ve d i n q ualit y 
ass ura n ce a n d i ns p ecti o ns (see a b o v e) will nee d direct access t o pri mar y s u bject data, 
e. g., me di cal rec or ds, a p p oi nt me nt b o o ks, etc. T he re vie w of me dical rec or ds will b e 
perf or me d i n a ma n n er t o e ns ure t h at s u bj ect c o nfi d e ntialit y is mai ntai ne d. Beca use t his 
affects t he s u bject’s c o nfi de ntialit y, t his fact is i n cl u de d o n t he S u bj ect I nf or mati o n S h eet 
a n d I nf or me d C o nse nt F or m. T he I n v esti g at or ass ures t h e S p o ns or of t h e n ecessar y 
s u p p ort at all ti mes. 
T his trial is or ga nise d b y L u me nt A B, a n d all e n q uiries s h o ul d be ma de t o a me m ber of 
L u me nt A B staff (se e S ecti o n 2 ). 
1 5. 3  C o nfi de nti alit y 
All trial fi n di n gs a n d d oc u me nts will be re gar d e d as c o nfi de ntial. T h e I n vesti gat or a n d 
me m bers of his/ her researc h t ea m m ust n ot dis cl ose s u c h i nf or m ati o n wit h o ut pri or 
writte n a p pr o val fr o m t he S p o ns or. 
T he a n o n y mit y of partici pati n g s u bjects m ust b e mai nt ai ne d. S u bjects will be i d e ntifie d 
o n C R Fs b y t h eir s u bject n u m ber. O n t he S A E re p orts a n d all ot her s o urce d oc u me nts, 
t he s u bject will be i d e ntifie d via s u bj ect n u m b er. D oc u me nts ar e n ot t o be s u b mitt e d t o 
t he S p o ns or t h at i d e ntif y t he s u bj ect (e. g., t h e si g n e d i nf or me d c o ns e nt) m ust be 
mai ntai n e d i n c o nfi d e nce b y t h e I n v esti g at or.  


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
4 6 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 5. 4  S o urce D at a 
S o urce d at a : All i nf or mati o n i n ori gi n al rec or ds a n d certifi e d c o pies of ori gi n al rec or ds 
of cli nical fi n di n gs, o bs er vati o ns, or ot her acti vities i n a cli nical trial necessar y f or t he 
rec o nstr ucti o n a n d e val u ati o n of t h e tri al. S o urce data are c o nt ai ne d i n s o urce d oc u m e nts 
( ori gi n al rec or ds or certifie d c o pi es) (I C H E 6, 1. 5 1). 
S o urce d oc u me nts : Ori gi n al d oc u me nts, d ata, a n d rec or ds (e. g., h os pital rec or ds, cli nical 
a n d office c h arts,  me m ora n d a, s u bje cts diaries or e val uati o n c h ec klists, p har mac y 
dis p e nsi n g rec or ds, rec or de d dat a fr o m a ut o mate d i nstr u me nts, c o pies or tra nscri pti o ns 
certifi e d aft er v erific ati o n as b ei n g acc urat e c o pies, micr ofic hes, p h ot o gra p hic n e gati ves, 
micr ofil m or ma g netic m e dia, x-ra ys, s u bject files, a n d rec or ds ke pt at t he p har mac y, at 
t he la b orat ories a n d at m e dic o-tec h ni cal de p art m e nts i n v ol ve d i n t he cli ni cal trial). (I C H 
E 6, 1. 5 2). 
S D V is a ke y f u n cti o n i n ass uri n g t he s p o ns or t hat cli nical trial i nf or mati o n is rec or de d 
a n d ha n dl e d i n a w a y t h at all o ws its acc urate re p orti n g, i nter pretati o n a n d v erificati o n. 
M o nit ors will, d uri n g t he c o n d u ct of t he cli nical trial, perf or m S D V t o c o nfir m t he 
acc urac y a n d c o m pl ete ness of C R Fs b y verif yi n g dat a rec or de d i n t he C R F a gai nst d ata 
rec or d e d i n s o urce d oc u me nts t o e ns ure s u c h rec or ds are c o nsiste nt.  
T o e na bl e S D V, it is esse ntial t h at s o urce data/ d oc u me nts (see defi niti o n a b o v e) f or t he 
trial data t o b e c ollecte d i n t h e C R F as w ell as w h ere s u c h data ca n b e f o u n d at t he trial 
site is esta blis he d a n d a gree d wit h t h e i n v esti g at or at eac h trial site a n d d oc u me nte d, pri or 
t o i nitiati o n of t h e cli nical trial. T he C R F is esse ntiall y c o nsi dere d a data e ntr y f or m a n d 
s h o ul d n ot c o nstit ute t he ori gi n al ( or s o urce) me di cal rec or ds u nless ot her wise s pecifie d 
i n t he Ori gi n of s o urce d ata d oc u me nt at site. 
F or t his trial, si nce data are e ntere d i nt o C R F, all p ara met ers c ollecte d i n t h e C R F s h o ul d 
be v erifia bl e fr o m s o ur ce d oc u me nts a vaila ble o n site. T h ese para meters i n cl u d e, b ut are 
n ot li mite d t o: 
 A st at e me nt t hat t h e s u bj ect partici p at es i n a cli ni cal trial 
 T he i d e ntit y of t he trial e. g., Trial c o de 
 S u bject / n u m b er 
 date of c o n d u cti n g i nf or me d c o nse nt pr ocess 
 data f or e val uati o n of eli gi bilit y criteria 
 dis p e nsati o n/a d mi nistrati o n of tri al me di cati o n 
T he I n vesti g at or is res p o nsi ble f or e ns uri n g t h e acc urac y, c o m pl et e n ess, le gi bilit y a n d 
ti meli ness of t he data rec or de d i n t he C R Fs. Data re p ort e d i n t h e C R F t hat are deri ve d 
fr o m s o urce d o c u me nts s h o ul d be c o nsiste nt wit h t he s o urce d oc u me nts or t he 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
4 7 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
discre pa n cies s h o ul d b e e x plai ne d. C o m plete d secti o ns of C R Fs will be m o nit ore d o n a 
re g ul ar b asis. 
1 5. 5  C ase Re p o rt F or ms ( C R Fs) 
Data c ollecte d i n t his trial will be b y mea ns of p a per C R Fs.  
T he C R Fs m ust be mai ntai ne d i n a n u p-t o- date c o n diti o n at all ti mes b y t he i n vesti gat or. 
T he i n vesti gat or, or s u b-i n vesti gat or(s) a ut h orise d b y t h e i n vesti gat or, will si g n all 
secti o ns of C R Fs use d. T his si g nat ure i nf or mati o n (i ncl. date of si g nat ure) will be ke pt i n 
t he a u dit trail a n d is u naltera bl e. O nl y a p pr o priat el y me dicall y q ualifie d 
(s u b)i n vesti g at ors ca n si g n dat a o n cli ni cal ass ess m e nts/safet y. A n y c orrecti o n(s) ma de 
b y t h e i n vesti gat or, or a ut h oris e d sit e staff, t o t h e C R F after ori gi nal e ntr y will be 
d oc u me nt e d i n t he a u dit trail. C h a n ges t o data alrea d y a p pr o ve d, re q uires t he re-si g nat ure 
of i n vesti gat or or a ut h orise d staff. T he a u dit trail will i de ntif y t he pers o n ma ki n g t he 
c ha n ge a n d t he d ate, ti me a n d reas o n f or t he c ha n g e.  
T he trial m o nit or will c hec k t he C R Fs f or acc urac y a n d c o m pl eti o n a n d p erf or m s o urce 
data verificati o n. F or arc hi vi n g p ur p os es, eac h i n vesti gat or will be s u p plie d wit h a c o p y 
of t h e C R Fs, f or all pati e nts e nr oll e d at t h e site. A u dit trail i nf or mati o n will be i n cl u de d. 
C R Fs will be a vaila ble f or i ns pecti o n b y a ut h orise d re pres e nt ati ves fr o m L u me nt A B, 
fr o m Re g ulat or y A ut h orities a n d/ or I E C. 
1 5. 6  D at a M a n a g e me nt 
P atie nt dat a s h o ul d b e e nt ere d i nt o t he C R F b y a ut h orise d site st aff i n a ti m el y ma n ner 
a n d n ot l ater t ha n a wee k after t he p atie nts’ visits. Data will be e ntere d o n t he p a per C R F 
b y site st aff  
W he n a p a per C R F is c o m pl ete d a n d si g ne d b y sit e staff it will b e se nt t o Stat C o ns f or 
data e ntr y. P ers o n n el at St at C o ns will e nter t he data i nt o a n electr o ni c data b ase. T he d ata 
e ntr y will b e v erifie d b y pr o ofrea di n g b y p ers o n nel at Stat C o ns. W he n all dat a fr o m all 
pa per C R Fs are e nt ere d i nt o t he el ectr o nic d ata base a n d pr o ofrea d t h e d ata base will b e 
l oc ke d a n d se n d t o t he s p o ns or f or arc hi vi n g. As well t he statisti cal a nal ys es/s u m maries 
will start base d o n data i n t h e l o c ke d data b ase. 
A n y de viati o ns, i.e., discre pa ncies a n d a d diti o ns fr o m t he pr ocess d efi n e d i n t h e Data 
Ma na ge me nt Pl a n, will be descri b e d i n t h e statistical re p ort. 
1 5. 7  Arc hi vi n g Tri al Rec or ds 
Acc or di n g t o I nter nati o n al C o nfere n ce o n H ar m o nisati o n (I C H) g ui deli nes, esse nti al 
d oc u me nts s h o ul d be retai n e d f or a mi ni m u m of 2 years after t he l ast a p pr o val of a 
mar keti n g a p plicati o n i n a n I C H re gi o n a n d u ntil t here are n o p e n di n g or c o nte m plate d 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
4 8 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
mar keti n g a p plicati o ns i n a n I C H re gi o n or at least 2 y ears ha ve ela ps e d si nce t he f or mal 
disc o nti n u ati o n of cli nical de vel o p me nt of t he i n v esti gati o nal pr o d uct. H o w e ver, t hes e 
d oc u me nts s h o ul d be retai n e d f or a l o n ger peri o d if re q uire d b y t h e a p pli ca ble l e gal 
re q uire me nts. 
 
 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
4 9 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 6  T R I A L M A N A G E M E N T  
1 6. 1  Ti me Sc he d ule 
 Pla n n e d date of e nr ol me nt of first patie nt: Ja n uar y 2 0 2 3. 
 Pla n n e d date of e nr ol me nt of l ast patie nt: Fe br uar y 2 0 2 3. 
1 6. 2  Pr ot oc ol A me n d me nts 
Neit h er t he i n v esti g at or(s) n or L u me nt A B will c ha n g e t h e Cli ni cal St u d y Pr ot o c ol 
wit h o ut writte n a gree m e nt bet wee n L u me nt A B a n d t h e I n vesti gat or. A n y m o dificati o n 
c o nsi d ere d s u bsta ntial re q uires a p pr o v al/fa v o ura ble o pi ni o n b y t he a p pr o priate re g ulat or y 
a ut h orit y a n d I E C/I R B. 
N o n-s u bsta ntial c ha n ges (e. g., C h a n ges n ot affecti n g t h e s u bj ect b e nefit/ris k rati o) ma y 
be ma de wit h o ut t he ne e d f or a f or mal I E C/ C o m p ete nt A ut h orit y a p pr o val. All n o n-
s u bst a nti al a me n d me nts will b e l o g ge d o n a n o n-s u bsta ntial a me n d me nt list. All n o n-
s u bst a nti al a me n d me nts will b e distri b ute d t o all pr ot oc ol reci pie nts, wit h a p pr o priate 
i nstr ucti o ns. 
Pr ot oc ol a me n d me nts are iss ue d as C o ns oli date d Cli nical St u d y Pr ot oc ols c o m prisi n g all 
c urre nt a me n d me nts. C o ns oli date d Cli nical St u d y Pr ot oc ols bec o me effecti ve w he n 
writte n a p pr o val h as bee n pr o vi d e d b y t he I n v esti g at or, t he S p o ns or, a n d 
a p pr o v al/fa v o ura ble o pi ni o n fr o m re g ul at or y a ut h oriti es a n d/ or I E C has bee n o btai n e d, as 
re q uire d. 
1 6. 3  A gree me nts 
Bef ore t he i nitiati o n of a cli nical trial at a trial site, all fi n a ncial arra n g e me nts wit h t he 
i n v esti g at or/i nstit uti o n a n d all ot her rele v a nt parti es (s uc h as la b orat ories) m ust be 
c o nfir me d i n writi n g i n f or mal a gree me nt(s). 
1 6. 4  D ur ati o n of t he Tri al 
T he d urati o n of t he tri al f or eac h s u bj ect fr o m scree ni n g t o t h e F oll o w- u p ( or earl y 
ter mi n ati o n) visit will be u p t o 1 7 da ys, d e pe n di n g o n t he a vaila ble ti me sl ots f or M R E 
e xa mi nati o n.  
T he trial will be cl os e d w h e n all e nr olle d s u bje cts ha ve c o m plete d t h e last s u bject l ast 
visit, as d efi n e d i n secti o n 8. 4 Defi niti o n of E n d of St u d y. 
1 6. 5  C o m pleti o n of Tri al 
1 6. 5. 1  Tri al C o m pl eti o n Pr oce d ures 
T he e n d of trial is defi ne d as t he d ate of t h e last s u bject l ast visit. 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
5 0 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
T he I n vesti g at or will be i nf or me d w he n s u bj ect recr uit m e nt is t o cease. 
Trial e nr ol me nt will be st o p pe d w he n t he t ot al re q ueste d n u m b er of e val ua ble s u bjects f or 
t he tri al has b ee n o bt ai ne d i.e., 1 0 s u bjects. 
U p o n c o m pleti o n of t he tri al, L u me nt A B will u n derta ke arra n ge me nts f or c ollecti o n a n d 
dis p osal of a n y u n use d tri al material t hat t he i n vesti gat or is n ot re q uire d t o k ee p i n his/ her 
fil es. 
T he trial ma y st o p pre mat urel y if t h e I n v esti gat or or t h e S p o ns or bec o mes a ware of 
c o n diti o ns or e ve nts t h at s u g gest a p ossi ble h azar d t o s u bjects if t h e trial c o nti n ues. I n t his 
case, t he tri al ma y be ter mi n ate d after a p pr o priate c o ns ult ati o n bet wee n t he rele va nt 
parties. T h e trial ma y als o be ter mi nate d earl y at t he S p o ns or’s discreti o n i n t he a bse nce 
of s uc h a fi n di n g. 
C o n diti o ns t h at ma y warra nt ter mi nati o n i n cl u de, b ut are n ot li mit e d t o: 
 T he disc o ver y of a n u ne x pecte d, si g nifica nt, or u n acce pt a ble ris k t o t he s u bjects 
e nr olle d i n t h e trial. 
 Fail ure t o e nr ol s u bj ects at a n acce pta ble rate. 
 A d ecisi o n o n t he part of t h e S p o ns or t o s us pe n d or disc o nti n u e de vel o p me nt of 
L u me nti n  4 4. 
1 6. 6  Li a bilit y a n d I ns ur a nce 
L u me nt A B will ta ke o ut reas o na bl e t hir d- part y li a bilit y i ns ura n ce c o v er i n acc or da nce 
wit h all l ocal l e gal re q uire me nts. T he ci vil li a bilit y of t he I n vesti gat or, t he pers o ns 
i nstr ucte d b y hi m/ h er a n d t he h os pital, practi ce or i nstit ute i n w hi c h t he y are e m pl o ye d 
a n d t he lia bilit y of t h e S p o ns or wit h res p ect t o fi na n ci al l oss d ue t o pers o nal i nj ur y a n d 
ot h er d a ma ge t h at ma y arise as a res ult of t h e carr yi n g o ut of t his tri al are g o ver ne d b y t he 
a p pli ca ble l a w. 
L u me nt A B will arra n ge f or Lia bilit y I ns ura nce if s u bjects s h o ul d b e i nj ure d d u e t o t he 
partici pati o n i n t h e trial a n d pr o vi d e d t h at s p o ns or is le gall y lia ble f or t hat. 
E xcl u de d fr o m t he i ns ura nce c o v er are i nj uries t o healt h a n d deteri orati o ns of ill nesses 
alrea d y i n e xiste nce w hi c h w o ul d ha ve occ urre d or c o nti n ue d t o e xist e ve n if t he s u bject 
ha d n ot t a ke n p art i n t he cli nical tri al. 
T he i ns ura nce c o ver is j e o par dis e d if t he s u bj ect fails t o re p ort i m m e diatel y t o t h e 
I n v esti gat or or res p o nsi ble p h ysicia n a n y i nj ur y t o healt h, w hic h mi g ht ha ve res ulte d 
fr o m partici pati o n i n t he cli ni cal trial, or if he/s he u n d er g oes a n y ot h er me dical treat me nt 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
5 1 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
wit h o ut t heir c o nse nt bef ore t he cli ni cal tri al h as bee n fi nis he d i ns ofar as t h e i n di vi d ual 
s u bj ect is c o ncer n e d. 
A n y i nj ur y t o h ealt h, w hic h mi g ht h a ve occ urre d as a res ult of partici pati o n i n t he cli ni cal 
trial, m ust be re p orte d b y t he s u bject t o t h e I n vesti gat or wit h o ut d ela y. T he I n v esti gat or is 
o bli g e d t o ma k e s u c h a re p ort i n a n y cas e. 
1 6. 7  Use of i nf or m ati o n 
All u n p u blis he d i nf or m ati o n relati n g t o t his cli nical trial a n d/ or t o t he i n v esti g ati o nal 
pr o d uct(s), is c o nsi dere d c o nfi de ntial b y L u me nt A B a n d s h all re mai n t h e s ol e pr o pert y 
of L u m e nt A B. T he i n vesti g at or s h o ul d u n dersta n d a n d a gree t h at L u me nt A B ma y use 
t he i nf or mati o n fr o m t his cli ni cal trial i n c o n n ecti o n wit h t he de vel o p m e nt of t h e pr o d uct, 
a n d t heref ore, ma y dis cl ose it as re q uire d t o ot her i n vesti gat ors, t o re g ulat or y a ut h orities 
a n d c o m mercial part n ers. 
1 6. 8  P u blic ati o n P olic y 
B y si g ni n g t he trial pr ot oc ol, t h e I n vesti gat or a grees wit h t he use of res ults of t he tri al f or 
t he p ur p oses of n ati o nal a n d i nter n ati o nal re gistrati o n, p u blicati o n a n d i nf or mati o n f or 
me di cal a n d p har mace utical pr ofessi o nals. If necessar y, t h e a ut h orities will be n otifie d of 
t he I n v esti g at or's na me, a d dress, q u alificati o ns a n d e xte nt of i n v ol ve me nt. 
A n i nte grate d cli nic al trial re p ort will b e pre pare d b y t he S p o ns or a n d re vie we d b y 
I n v esti gat or. A s u m mar y of t h e cli nical trial re p ort (acc or di n g t o C P M P/I C H 1 3 7/ 9 5) 
s h o ul d be se nt t o t he R e g ulat or y A ut h orities a n d I E C acc or di n g t o t h e rele v a nt g ui deli nes. 
N o data fr o m t h e cli nical trial ma y b e p u blis he d, prese nte d or c o m m u ni cate d, e xce pt t o 
re g ul at or y a ut h orities, pri or t o t h e release of t he i nt er nal cli nical tri al re p ort, u nless 
a p pr o v e d b y t he S p o ns or i n writi n g. 
I n t he e ve nt of a p u bli cati o n, t h e na mes of t he a ut h ors a n d t heir or der of a p peara n ce will 
be i n acc or da nce wit h t he a gree m e nt i nt er peers, vi z. pa pers m ai nl y deali n g wit h me dical 
a n d gastr oe nter ol o gical d ata will prese nt t h e n a me of t he pri nci pal gastr oe nter ol o gist first 
( or l ast if wis h e d f or). Pa pers mai nl y deali n g wit h ra di ol o gi c iss ues will prese nt t he na me 
of t h e pri nci pal ra di ol o gist first ( or l ast if wis he d f or). T he sec o n d n a me will b e t h e 
pri nci pal a ut h or of t he ot her s p ecialit y. All ot her a ut h ors will pri maril y be prese nte d i n 
al p ha betic or d er. 
 
 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
5 2 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 7  R E F E R E N C E L I S T 
Lea n der P, A d ner hill I, B ö ö k O, Casal- D ujat L, Stat his G, F or k T. A n o v el f o o d- bas e d 
f oa m as oral c o ntrast a g e nt wit h n e gati ve H o u nsfiel d u nits f or de marcati o n of s mall 
b o wel l o o ps o n a b d o mi nal C T: t olera bilit y a n d b o wel diste nsi o n i n 2 5 v ol u nteers. Acta 
Ra di ol. 2 0 2 1 Dec; 6 2( 1 2): 1 5 5 9- 1 5 6 6.  
Lea n der P, St at his G, Casal- D ujat L, B o ma n K, A d ner hill I, M arsal J, B ö ö k O, F or k T. A 
n o vel f o o d- bas e d ne g ati v e oral c o ntrast a ge nt c o m pare d wit h t w o c o n ve nti o n al oral 
c o ntrast a ge nts i n a b d o mi nal C T: a t hree-ar m parallel bli n d e d ra n d o mise d c o ntr olle d 
si n gle-ce ntre trial. E ur R a di ol E x p. 2 0 2 2 A pr 5; 6( 1): 1 5.  
 
 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
5 3 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 8  A P P E N D I C E S  
1 8. 1  A p pe n di x 1: L u me nti n 4 4 rec o nstit uti o n pr ot oc ol s u m m ar y  
S U M M A R Y O F C M P D U O P E R A TI O N 
Gl o ves o n 
I. F or t he pre p arati o n f or o ne trial s u bject, gat h er t w o L 4 4 p o w der s ac hets, t w o glass j ars, 
t w o 1. 5- L P E T j ars a n d t w o 0. 5- L b ottles of wat er. 
P R E P A R A TI O N O F T H E FI R S T F O A M 
2. Fill i n t h e B E F O R E F O A M P R E P A R A TI O N s ecti o n o n t he W hi p pi n g 
re p ort _ L U M RI S- 0 0 1 V 3. 0. 
3. O pe n o ne L 4 4 p o w d er sac het a n d p o ur t he e ntir e sac het of p o w der i nt o o ne of t he gl ass 
jars o utsi d e t h e mi xi n g c ha m ber of t he C M P D U. 
4. Ma ke s ure t he C M P D U is s u p plie d wit h electricit y a n d t ur n o n p o wer ( b utt o n o n t he 
bac k si de). 
5. O pe n t h e mi xi n g c ha m ber d o or. 
6. I nstall t h e mi xi n g t o ol. 
7. P ut t h e jar i nt o t h e mi xi n g c ha m ber. 
8. C L O S E t he mi xi n g c ha m b er d o or. 
9. O pe n t h e wat er b ottl e. 
1 0. C o n nect w at er b ottle t o t he C M P D U. 
1 1. Ma ke s ure t h e water b ottl e is ti g hte ne d e n o u g h t o t h e c o n nect or a n d t h e b ottle is 
place d at t h e l o w er p ositi o n, s o water sta ys i n t he b ottle. 
1 2. Press t he start b utt o n. 
1 3. Fli p t h e b ottle t o t h e t o p p ositi o n. 
1 4. Wait u ntil t h e L 4 4 f oa m rec o nstit uti o n is fi nis h e d, w hic h is i n dicate d b y t he c o m plete 
li g hte ne d L E D li g hts o n t he H MI. 
1 5. Fli p d o w n t he wat er b ottle. 
1 6. O pe n t he mi xi n g c ha m ber d o or. 
1 7. Ta ke o ut t he mi xi n g t o ol wit h a pi ece of kitc he n pa per t o wel u n d er neat h t o c o ntai n 
t he e xcess f oa m fr o m t he bla de; was h t he mi xi n g t o ol a n d dr y it wit h kitc he n pa per t o wel. 
I nstall bac k t he mi xi n g t o ol t o t he C M P D U. 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
5 4 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 8. Ta ke o ut t he jar fr o m t h e mi xi n g c ha m ber a n d cl ose t h e d o or of t he mi xi n g c ha m ber. 
1 9. Fill i n t he A F T E R F O A M P R E P A R A TI O N secti o n o n t h e W hi p pi n g 
re p ort _ L U M RI S- 0 0 1 _ V 3. 0. 
2 0. G E N T L Y p o ur o ut L 4 4 t o a 1. 5- L P E T jar. 
2 1. Ta ke t he 1. 5- L P E T j ar wit h L 4 4 f oa m a n d wal k t o war ds w here t he trial s u bject is 
sitti n g. 
2 2. Gi v e t h e trial s u bject t h e L 4 4 f oa m i n t he 1. 5- L P E T j ar a n d a s mall dri n ki n g c u p. 
2 3. G o bac k t o pre pare t h e sec o n d jar of L 4 4 acc or di n gl y. 
P R E P A R A TI O N O F T H E S E C O N D F O A M 
2 4. Fill i n t he B E F O R E F O A M P R E P A R A TI O N secti o n o n t h e W hi p pi n g 
re p ort _ L U M RI S- 0 0 1 V 3. 0. 
2 5. O pe n o ne L 4 4 p o w der sac het a n d p o ur t he e ntire sac h et of p o w d er i nt o o ne glass jar 
o utsi de t h e mi xi n g c ha m ber of t h e C M P D U. 
2 6. Ma ke s ure t h e p o wer is o n. 
2 7. O pe n t he mi xi n g c ha m ber d o or. 
2 8. I nstall t h e mi xi n g t o ol. 
2 9. P ut t h e jar i nt o t he mi xi n g c ha m ber. 
3 0. C L O S E t he mi xi n g c ha m ber d o or. 
3 1. O pe n a ne w b ottl e of water b ottl e. 
3 2. Re place t h e e m pt y b ottl e of water wit h t h e n e w b ottle; c o n nect t he ne w wat er b ottle 
t o C M P D U. 
3 3. Ma ke s ure t h e water b ottl e is ti g hte ne d e n o u g h t o t h e c o n nect or a n d t h e b ottle is 
place d at t h e l o w er p ositi o n, s o t he water sta ys i n t he b ottle. 
3 4. Press t he start b utt o n. 
3 5. Fli p t h e b ottle t o t h e t o p p ositi o n. 
3 6. Wait u ntil L 4 4 f oa m rec o nstit uti o n is fi nis he d, w hic h is i n dicate d b y t he c o m plete 
li g hte ne d L E D li g hts o n t he H MI. 
3 7. Fli p d o w n t he wat er b ottle. 
3 8. O pe n t he mi xi n g c ha m ber d o or. 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
5 5 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
3 9. Ta ke o ut t he mi xi n g t o ol wit h a pi ece of kitc he n pa per t o wel u n d er neat h t o c o ntai n 
t he e xcess f oa m fr o m t he bla de; was h t he mi xi n g t o ol q uic k y wit h ta p water a n d dr y it 
wit h kitc he n pa per t o w el. I nstall bac k t he mi xi n g t o ol t o t he C M P D U. 
4 0. Ta ke o ut t he jar fr o m t h e mi xi n g c ha m ber a n d cl ose t h e d o or of t he mi xi n g c ha m ber. 
4 1. Fill i n t he A F T E R F O A M P R E P A R A TI O N secti o n o n t h e W hi p pi n g 
re p ort _ L U M RI S- 0 0 1 _ V 3. 0. 
4 2. G E N T L Y p o ur o ut L 4 4 f oa m t o t h e 1. 5- L P E T j ar. 
4 3. Ta ke t he 1. 5- L P E T j ar wit h L 4 4 f oa m a n d wal k t o war ds w here t he trial s u bject is 
sitti n g. 
4 4. Gi v e t h e trial s u bject t he L 4 4 f oa m i n t he 1. 5- L P E T j ar a n d a s mall dri n ki n g c u p. 
4 5. G o bac k t o t h e C M P D U. 
4 6. Disc o n n ect t he e m pt y water b ottl e if t his is t he last f oa m t o pre pare of t h e da y; 
ot h er wise, l ea v e t h e b ottle c o n necte d bef ore ma ki n g a ne w f o a m wit h a ne w b ottle of 
water. 
4 7. Rec ycl e t h e w ater t u bi n g set bac k t o L u me nt A B after t h e last f oa m of t he da y. 
4 8. After t he last f oa m of t he d a y, ha n d w as h t he mi xi n g t o ol wit h f o o d- gra de deter ge nt 
a n d dr y wit h kitc he n tiss ue t o wel or w as h t h e mi xi n g t o ol i n t he dis h was her (f o o dst uff 
c o m p ati ble is s ufficie nt). 
4 9. Wi pe t he mi xi n g c ha m ber if a n y visi ble L 4 4 h as dr o p p e d. 
5 0. P o wer off t he C M P D U at t h e e n d of t he d a y ( b utt o n o n t he bac k si de of t h e C M P D U). 
5 1. If t here is a n y f oa m dr o p pe d o nt o t he jar h ol der, press t h e cl ea ni n g m o d e b utt o n t o let 
l o ose t h e jar h ol der. 
5 2. Ha n d was h or was h i n t h e dis h was her t he jar h ol d er. 
5 3. Fi x t h e jar h ol der b ac k i nt o t he mi xi n g c ha m ber o n ce it's clea ne d. 
 
 
 


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
5 6 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
1 9  S I G N A T U R E P A G E S 
 
Decl ar ati o n of S p o ns o r o r Res p o nsi ble Me di c al Officer 
Title: A n u nc o ntr olle d, si n gle ce ntre, healt h y v ol u nteer, P hase II pr o of- of-c o n ce pt trial 
i n v esti g ati n g M R-e nter o gra p h y i ma ge q u alit y of L u m e nti n®  4 4, a ne w e g g al b u me n 
base d oral s mall b o wel filli n g c o ntrast a ge nt. 
T his trial pr ot o c ol was s u bject e d t o criti cal re vi e w. T he i nf or mati o n it c o ntai ns is 
c o nsiste nt wit h c urre nt k n o wle d g e of t h e ris ks a n d be nefits of t h e i n vesti gati o nal pr o d uct, 
as well as wit h t he m oral, et hical a n d scie ntific pri n ci ples g o ver ni n g cli nical researc h as 
set o ut i n t he Decl ar ati o n of Helsi n ki, re vise d 2 0 1 3, a n d t he g ui d eli n es o n G o o d Cli nical 
Practice ( G C P). 
 
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
Ja n Marsal, M D, P h D 
Date 
  
De part me nt of Gastr oe nt er ol o g y 
S ka ne U ni v ersit y H os pital 
S U S L u n d E A 1 2 
S E- 2 2 1 8 5 L u n d 
S we de n 
P h o n e: + 4 6 4 6 1 7 7 0 0 3 
M o bile p h o ne: + 4 6 7 0 9 8 2 2 0 0 8 
E- mail: j a n. marsal @ me d.l u.se 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
J o ha n Q u e nsel, C E O 
Date 
Q Cli nical R esearc h C o ns ulti n g A B 
Lärar v ä ge n 1 2 
S E- 2 4 7 4 5 T or na Hällest a d 
S we de n 
P h o n e: + 4 6 7 6 0 4 6 9 7 4 4 
E- Mail: j q @ qcrc.se  


S p o ns or: L u me nt A B  
 Cli ni cal Trial Pr ot oc ol 
Pr ot oc ol: L U M RI S- 0 0 1, versi o n 2. 0 Fi nal 
 C O N FI D E N TI A L 
 
 
 
Versi o n 2. 0, Fi n al  
5 7 of 5 7   
1 5 t h N o ve m ber 2 0 2 2 
Decl ar ati o n of t he I n vesti g at or 
Title:  A n u nc o ntr olle d, si n gle ce ntre, healt h y v ol u nteer, P hase II pr o of- of- c o nce pt trial 
i n v esti g ati n g M R-e nter o gra p h y i ma ge q u alit y of L u m e nti n®  4 4, a ne w e g g al b u me n 
base d oral s mall b o wel filli n g c o ntrast a ge nt. 
T his trial pr ot o c ol was s u bject e d t o criti cal re vi e w. T he i nf or mati o n it c o ntai ns is 
c o nsiste nt wit h c urre nt k n o wle d g e of t h e ris ks a n d be nefits of t h e i n vesti gati o nal pr o d uct, 
as well as wit h t he m oral, et hical a n d scie ntific pri n ci ples g o ver ni n g cli nical researc h as 
set o ut i n t he Decl ar ati o n of Helsi n ki, re vise d 2 0 1 3, a n d t he g ui d eli n es o n G o o d Cli nical 
Practice ( G C P). 
 
 
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
Si g nat ure  
  
  
  
  
  
Date 
 
Dr. Peter Lea n der 
R ö nt ge n, Perit us kli ni k e n A B 
S c heele vä g e n 8 
2 2 3 6 3 L u n d 
S we de n 
 
P h o n e: + 4 6 4 6 2 8 8 6 0 3 0 
M o bile p h o ne: + 4 6 7 6 8 8 7 1 0 6 9 
E- Mail: peter.lea n der @ perit us kli ni ke n.se