An Open, Randomized, Controlled, Single Centre Trial to Evaluate CT Image Quality and Diagnostic Feasibility of Lumentin® 44, in Comparison With Omnipaque and Movprep.
Phase: PHASE2
Conditions: Subjects Referred to CT-examination of the Abdomen
Sponsor: Lument AB

 
 
CLINICAL TRIAL PROTOCOL 
 
An open, randomized, controlled, single centre trial to evaluate CT image quality and 
diagnostic feasibility of Lumentin® 44, a new egg albumen based oral bowel filling agent, 
in comparison with diluted Omnipaque® and Movprep®, two commonly used agents in 
subjects referred for abdominal CT-examination. 
 
Sponsor: 
Lument AB 
Olof Böök 
Scheelevägen 22 
Box 719 
SE-220 07 Lund 
Sweden 
Clinical Research Organization: 
Q Clinical Research Consulting AB 
Johan Quensel 
Lärarvägen 12 
SE-247 45 Torna Hällestad 
Sweden 
Investigator 
Dr. Peter Leander 
Verksamhetsområde Bild och funktion  
Skånes Universitetssjukhus 
Inga Marie Nilssons gata 49 
SE-205 02 Malmö 
Sweden 
Sponsor Protocol No.: 
LUM-001 
Protocol Version 
4.0 
EudraCT No.: 
2017-002368-42 
Trial Drug Name: 
Lumentin® 44 
Development Phase: 
II 
Date of Protocol: 
05 July 2018 
Date of Previous Protocol: 
11 December 2017 
This document contains confidential information. The contents may not be used, divulged or published 
without prior written consent of Lument AB.  
This information cannot be used for any other purpose than the conduct and evaluation of the clinical 
investigation by the investigator(s), the regulatory authorities and members of the ethics committees

Sponsor: Lument AB
Protocol: LUM-001, version 4.0
Clinical Trial Protocol
CONFIDENTIAL
SIGNATURE PAGE
Dcclaration of Sponsor or Responsible Medical Officer
Title: An open, randomized, controlled, single centre trial to evaluate CT image quality
and diagnostic feasibility of Lumentin@ 44, a new egg albumen based oral bowel filling
agent, in comparison with diluted Omnipaque@ and Movprepo, two commonly used
age
Thi
con
nts in subjects referred for abdominal CT-examination.
protocol was subjected to critical review. The information it contains is
1 with current knowledge ofthe risks and benefits of the investigational product,
AS
with the moral, ethical and scientific principles governing clinical research as
set o
ation of Helsinki, revised 201 3, and the guidelines on Good Clinical
Practi
CP).
/14
OlofB66k, CEO
Scheeleviigen 22
Box 71 9
SE-220 07 Lund
Date
Sweden
Phone:
E-Mail:
+46 708 76 I0 65
olof.book@lumentab.com
0S tv1 2{ tK
Quensel, CEO
Q Clinical Research Consulting AB
Larartdgen 12
SE-247 45 Torna Hellestad
Sweden
Phone: +46160 46 97 44
E-Mail: jq@qcrc.se
Date
Final
2of69
05 July 201 8

Sponsor: Lument AB
Protocol: LUM-001, version 4.0
Clinical Trial Protocol
CONFIDENTIAL
Declaration of the Investigator
'fitlc: An open, randomized, controlled, single centre trial to evaluate CT image quality
and diagnostic feasibility of Lumentino ,14, a new egg albumen based oral bowel filling
agent, in comparison with diluted Omnipaque@ and Movprep@, two commonly used
agents in subjects referred for abdominal CT-examination.
This trial protocol was subjected to critical review. The information it contains is
consistent with current knowledge ofthe risks and benefits ofthe investigational product,
as well as with the moral, ethical and scientific principles governing clinical research as
set out in the Declaration of Helsinki, revised 2013, and the guidelines on Good Clinical
Practice (GCP).
2ol&-o?'of
Signature
Date
Dr. Peter Leander
Verksamhetsomride Bild och funktion
Skines U niversitetssj ukhus
Inga Marie Nilssons gata 49
SE-205 02 Malmi,
Sweden
Phone: 
+46 40 338910
Mobile phone: 
+46168 811069
E-Mail: 
peter.leander@skane.se
Final
3 of69
05 July 2018

Sponsor: Lument AB 
Clinical Trial Protocol 
Protocol: LUM-001, version 4.0 
CONFIDENTIAL 
 
Final 
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05 July 2018 
Declaration of the Sub-Investigator 
Title: An open, randomized, controlled, single centre trial to evaluate CT image quality 
and diagnostic feasibility of Lumentin® 44, a new egg albumen based oral bowel filling 
agent, in comparison with diluted Omnipaque® and Movprep®, two commonly used 
agents in subjects referred for abdominal CT-examination. 
All documentation for this trial that is supplied to me and that has not been previously 
published will be kept in the strictest confidence. This documentation includes this trial 
protocol, Investigator's Brochure, Case Report Forms (CRFs), and other scientific data. 
The trial will not be commenced without the prior written approval of a properly 
constituted Independent Ethics Committee (IEC). No changes will be made to the trial 
protocol without the prior written approval of the Sponsor and the IEC, except where 
necessary to eliminate an immediate hazard to the subjects. 
I have read and understood and agree to abide by all the conditions and instructions 
contained in this protocol. 
 
Sub-Investigator of the local trial centre 
 
 
 
_____________________________________ 
_____________________ 
Signature 
Date 
 
_____________________________________ 
Name (block letters) 
 
_____________________________________ 
Title (block letters) 
 
_____________________________________ 
Institution (block letters) 
 
_____________________________________ 
Phone number 
 
 

Sponsor: Lument AB 
Clinical Trial Protocol 
Protocol: LUM-001, version 4.0 
CONFIDENTIAL 
 
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05 July 2018 
1 
PROTOCOL SYNOPSIS 
Title: 
An open, randomized, controlled, single centre trial to evaluate CT 
image quality and diagnostic feasibility of Lumentin® 44, a new egg 
albumen based oral bowel filling agent, in comparison with diluted 
Omnipaque® and Movprep®, two commonly used agents in subjects 
referred for abdominal CT-examination. 
Indication: 
Subjects referred to computed tomographic X-ray examination of the 
abdomen or thoraco-abdominal CT-examination 
Phase of 
development: 
II 
Primary objective 
To compare the mean difference in contrast density shown on 
abdominal CT-images when using the contrast agent Lumentin® 44, 
with abdominal CT-images using diluted Omnipaque® and with 
abdominal CT-images using Movprep® 
 
Secondary 
objectives 
− To describe and compare the ability of Lumentin® 44 to fill the bowel as 
compared to Movprep® and diluted Omnipaque®.  
− To describe and assess how Lumentin® 44 influences reading of the abdominal 
CT-examination as compared to Movprep® and diluted Omnipaque® with respect 
to:  
o Diagnostics with particular regard to parenchymal 
organs, lymphatic system and tissue compartments 
beyond the gastrointestinal tract 
− To investigate signs of degradation of Lumentin® 44 in terms of  
o Coalesence 
o Syneresis or drainage 
− Describe and compare the ability to eat/drink for each of three contrast agents 
with respect to: 
o Taste 
o Smell 
o Consistency  
o Ability to swallow 
o Fullness 
− Validity and repeatability of the primary endpoint 
− To evaluate safety and tolerability after oral administration of each of three 
contrast agents  
 

Sponsor: Lument AB 
Clinical Trial Protocol 
Protocol: LUM-001, version 4.0 
CONFIDENTIAL 
 
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Assessments 
Mean difference in contrast density 
The contrast will be assessed by both the investigator and the sub-
investigator, independently of each other, in the small bowel and 
expressed in Hounsfield Units (HU). The difference in contrast 
density between lumen and wall (mucosal lining) will be measured in 
9 locations of the small bowel as described below.  
The small bowel is divided in 6 sub-segments and defined as follows: 
− Duodenum is defined as the first part of small bowel down to 
ligament of Treitz; 
− Jejunum identified by its typical feathery mucosal pattern on Abd-
CT 
− The small bowel between the jejunum and terminal ileum is 
visually divided into three parts: 
o Proximal ileum is approximately defined as 30 cm / 4 
loops of small bowel following jejunum  
o Distal ileum is approximately 30 cm / 4 loops proximal 
to terminal ileum  
− Terminal ileum is defined as the last 15 cm of ileum mounding into 
the ileo-cecal valve  
The difference in contrast density is measured in two sites of each of 4 
of the defined sub-segments: duodenum, jejunum, proximal ileum, 
and distal ileum, and in the terminal ileum where (due to its shortness 
in length) only one site is selected.  
 
Two regions of interest (ROI) measuring 6 mm in diameter will be 
selected by the investigator in the lumen  of each segment except in 
the terminal ileum where only one region is selected. The ROIs will 
be placed where the lumen is best shown in the CT-image. The CT-
scan software will provide a mean HU measurement of each of the 
selected ROIs and the values will be recorded by the investigator.  
The HU of the wall will be set to +80HU as a standard for all 
measurements. It is not possible to discriminate between the lumen 
and the wall when Movprep® and Diluted Omnipaque® is used as 
contrast agents as they have a contrast similar to the wall contrast. 
 
In each segment, the difference in contrast density between bowel 
lumen and wall will be calculated by subtracting the pin point HU 
value(s) of the wall (set to +80HU) from the mean ROI HU value(s) 
of the lumen. Two differences in contrast density values will thus be 
generated for each segment except in the terminal ileum where only 
one value is generated. 
 

Sponsor: Lument AB 
Clinical Trial Protocol 
Protocol: LUM-001, version 4.0 
CONFIDENTIAL 
 
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The mean difference in contrast density in the small bowel is the sum 
of the differences in contrast density values (9 calculated values based 
on the observation of the investigator and 9 based on the sub-
investigator observations, ie. In all 18 observations) divided by 18. All 
segments to which the contrast agent has not reached and thus, the 
contrast cannot be measured will not be included in the mean 
difference.  The sum of the differences will in this case be divided by 
the number of measurable observations. The ability to fill the bowel 
will be investigated as a secondary objective, see below section 10.1.2 
 
Evaluation of ability to fill the bowel  
The bowel filling agent will be distributed along the length of small 
bowel, i.e. the extension, but also cause a local widening of the bowel 
loop, distension. The filling of each of the 5 selected sub-segments of 
the small bowel in terms of extension and distension will be examined 
on the CT-scan both the investigator and the sub-investigator, 
independently of each other, and graded using Likert scales between 1 
and 9. 
Extension scale:  
1. no sign of contrast agent;  
2. trace of contrast agent filling 
3. segment filled to ca. 25% 
4. segment filled to >25% but <50% 
5. filled to segment filled to 50%  
6. segment filled > 50% but <75% 
7. segment filled to ca. 75% 
8. segment filled to >75% but <100% 
9. segment filled to 100% 
The Extension score will be the sum of the grades both assessors and 
in each sub-segment and hence range from 10 to 90. 
Distension scale:  
1. no identifiable contrast agent 
2. a minimal amount of contrast agent is identified 
3. small amount of contrast agent, insufficient for placing a ROI 
of 6 mm 
4. amount of contrast agent just allowing for a ROI of 6 mm 
5. medium filled bowel loop 
6. slightly better than grade 5 
7. good filling 

Sponsor: Lument AB 
Clinical Trial Protocol 
Protocol: LUM-001, version 4.0 
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8. optimal filling 
9. excellent or almost overdistended 
The Distension score will be the sum of the grades both assessors and 
in each sub-segment and range from 10 to 90.  
 
Diagnostic ability when examining Abd-CT 
Diagnostic ability when examining Abd-CT will be assessed on the 
CT-scan by both the investigator and the sub-investigator, 
independently of each other. 
The following features will be assessed: 
− Small bowl appearance 
− parenchymal organs, i.e. pancreas, ovaries, urinary bladder 
− mesenterium and oment  
using a Likert scales of 1-9 ranging, where:  
 
1. impossible to observe details  
 
5. medium 
 
9. excellent resolution  
The Diagnostic ability score will be the sum of the scores from both 
assessors and range from 6 to 54.  
 
Degradation of contrast agents 
Degradation of Lumentin® 44 is founded on the two characteristics 
Coalesence and syneresis or drainage. 
 
Coalesence: 
 
0. No bubbles visually detectable at the CT-scan 
 
1. Bubbles visually detectable at the CT-scan 
 
Syneresis or drainage: 
 
0.  No syneresis or drainage, i.e. separation of air and liquid 
 
 
phases, observed 
 
1. Syneresis or drainage observed 
Sign of degradation will be assessed on the CT-scan, by both the 
investigator and the sub-investigator, independently of each other, in 
each of the 5 selected sub-segments of the small bowel. 
Degradation of contrast agents score will be the sum of the scores 
from both assessors and in each sub-segment and range from 0 to 20. 

Sponsor: Lument AB 
Clinical Trial Protocol 
Protocol: LUM-001, version 4.0 
CONFIDENTIAL 
 
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Ability to eat/drink the contrast agents 
Subjects will assess taste, smell, consistency, ability to swallow and 
fullness on a five degree-scale: 
1. Very negative/Very difficult/very full 
2. Negative/difficult/ full 
3. Neutral/medium/medium full 
4. Positive/easy/barely full 
5. Very positive, good/very easy/not at all full. 
Subjects will be handed an assessment form, see appendix 2, to be 
filled out during the period when the contrast agents are consumed. 
 
Primary efficacy 
variable 
The mean difference in contrast density in HU, expressed as the mean 
of 9 measurements of contrast density differences between bowel 
lumen and wall (mucosal lining) performed in the 5 selected sub-
segments of the small bowel. 
 
Secondary efficacy 
variables 
• Bowel filling properties (extension and distension) on Abd-CT in 
each of 5 selected sub-segments of the small bowel  
• Degradation (presence of bubbles and signs of sedimentation) on 
Abd-CT in each of 5 sub-segments of the small bowel 
• Diagnostic ability on Abd-CT of the parenchyma, lymphatic 
system and tissue compartments beyond the gastrointestinal tract.  
• Subject assessments of taste, smell, consistency, ability to swallow 
and fullness after swallowing the contrast agent  
 
Safety variables 
• Especially solicited adverse events (AEs), i.e. stomach ache, 
burping, letting go of wind, Nausea and sensation of fullness 
• Any treatment emerging adverse events  
• Any treatment emerging adverse drug reactions (ADR) 
• Safety laboratory evaluations (clinical chemistry) 
• The reasons for withdrawal from the trial 
 
Investigational 
product, 
formulation, dosage 
and mode of 
administration: 
Lumentin® 44  
The final formulation of the foam will be prepared at the clinic within 
one hour prior to use. A volume of 1000 ml ± 200 ml will be taken 
orally during a period of 45 minutes - 1 hour. 
 

Sponsor: Lument AB 
Clinical Trial Protocol 
Protocol: LUM-001, version 4.0 
CONFIDENTIAL 
 
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Comparator 
products, 
formulation, dosage 
and mode of 
administration: 
Diluted Omnipaque®  
30 mg Omnipaque 240 mg I/mL dissolved with water to the final 
volume of 1 000 ml 
Approximately 1 000 ml, taken orally during a period of 30 minutes to 
1 hour  
 
Movprep® 
Movprep® is distributed as two dose units, Unit A and Unit B. 
Dose Unit A and B is dissolved in 1000 ml water. 
Approximately 1 000 ml, taken orally during a period of 1/2 hour 
The final preparation of the investigational product, Movprep® and 
Diluted Omnipaque® will be performed at the clinic.  
 

Sponsor: Lument AB 
Clinical Trial Protocol 
Protocol: LUM-001, version 4.0 
CONFIDENTIAL 
 
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05 July 2018 
Trial design 
An open, randomized, controlled, single centre phase 2 trial. 
The open trial design is a consequence of each individual contrast 
agent being easy to recognize by subjects through taste and 
consistency and by the reading radiologists because of the unique 
image grey-scale caused by each individual agent. 
Subjects referred for -abdominal CT-examination will be invited by 
letter to participate in the study. This invitation is added to the referral 
letter that informs them on day and time for the CT-examination. 
Referral letters are routinely sent out within 4 weeks prior to the 
examination. All subjects who has received an invitation letter will be 
contacted by phone by a study nurse. Those subjects who are 
interested in participating will be forwarded a full patient information 
sheet. 
Patients at the oncology departments at the hospital of Lund and 
Malmö will also be informed about the trial. Posters will be placed at 
the departments and invitation letters will be handed out to those 
interested. 
 
Subjects interested in participating in the trial will, upon arrival to the 
clinic at the day of CT examination, be fully informed about the trial 
by the investigator. Eligible subjects will sign the consent to 
participate prior to randomisation and any treatment related 
procedures. 
 
Subject demography, medical history and concomitant medication is 
recorded and a clinical chemistry blood sample is taken just prior to 
drinking the oral contrast agent.  
 
Lumentin® 44 is given in volumes of 0.8 to 1.2 L and Omnipaque® 
and Movprep® is given according to the general praxis of care at the 
department “Verksamhetsområde Bild och funktion  
Skånes Universitetssjukhus”. At least 750 mL of Lumentin® 44 must 
be drunk. At least the recommended, according to the general praxis 
of care, volume of Omnipaque® and Movprep® must be drunk.  
The subjects will be asked to drink the solutions of oral contrast 
agents within one hour.  
During the time the contrast agent is drunk, the subjects will be asked 
to complete a questionnaire assessing taste, smell, consistency, 
fullness and ability to swallow the contrast agent. 
The CT-examination will be started within 10 minutes after the 
contrast agent has been drunk. The CT-examination lasts in average 
eight minutes.  
Just prior to the CT examination a standard dose of iodine contrast 
(Omnipaque® 350 mg I/mL) will be intravenously administered. 
 

Sponsor: Lument AB 
Clinical Trial Protocol 
Protocol: LUM-001, version 4.0 
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A post- examination clinical chemistry blood sample is taken prior to 
the subject is leaving the clinic and occurrence of any adverse events 
is recorded.  
 
The subjects are free to leave the clinic after 30 minutes post CT-
examination. 
 
For safety reasons, subjects will be contacted, within 12 to 48 hours 
after the examination, by the investigator and asked about occurrence 
of any adverse event. No other follow-up is planned. 
Trial population 
The trial population will consist of subjects who are referred to CT-
examination of the abdomen. The subjects must be able to provide 
written informed consent and meet all the inclusion criteria and none 
of the exclusion criteria. 
 
Number of subjects The target is to randomise 88 subjects with the goal to reach 80 
evaluable subjects.  
However, due to the duration of the trial is only one day for the 
subject, randomisation will stop when 80 evaluable subjects have 
completed the trial.  
Randomisation will be skewed so that 40 subjects will be allocated to 
the Lumentin arm and 20 each to the Omnipaque and Movprep arms. 
Main inclusion 
criteria 
Subjects will be entered into this trial only if they meet all of the 
following criteria: 
1. Subjects of either gender at least 18 years at the time of 
signing the informed consent.  
2. Females must either present a negative pregnancy test or be 
surgically sterile (hysterectomy or tubal ligation) or 
postmenopausal (i.e. experienced 12 consecutive months 
without menstruation) 
3. Having a clinical indication for CT-examination of the 
abdomen 
4. Having fasted (drinking allowed) for at least four hours prior 
to the intake of the contrast agent 
5. Patients participating in concurrent oncology trial must either 
participate in the follow up phase of the clinical trial and 
currently receive no trial drug treatment since at least 6 weeks, 
or receive a reduced maintenance dose of the trial treatment 
6. Following verbal and written information about the trial, the 
subject must provide signed and dated informed consent 
before any trial related activity is carried out. 
 

Sponsor: Lument AB 
Clinical Trial Protocol 
Protocol: LUM-001, version 4.0 
CONFIDENTIAL 
 
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Main exclusion 
criteria 
Subjects will not be enrolled if they meet any of the following criteria: 
1. IV administration of iodine is contraindicated 
2. Clinical suspicion, according to medical record, of fistula 
formation and/or leakage  
3. Having swallowing disorders preventing intake of the contrast 
agents 
4. Referral indication of small bowel disease(s) 
5. Known allergy to egg albumen.  
6. Known sensitivity to any of the components of the 
investigational product or comparators 
7. Having known manifest thyrotoxicosis 
8. Having known phenylketonuria 
9. Having known Glucose-6-phosphatase deficiency 
10. Has taken any medication, absorbed through the small bowel, 
less than four hours before intake of the investigational 
product or comparators 
11. Being, in the opinion of the investigator, unlikely to comply 
with the clinical trial protocol 
12. Previously randomised to participate in this trial  
13. Participating in, or having participated in another, non-
oncology clinical trial where the final trial treatment was given 
within the last 6 weeks 
14. Participating in an oncology clinical trial where the final full 
(i.e. non-maintenance) trial treatment was given within the last 
6 weeks 
 

Sponsor: Lument AB 
Clinical Trial Protocol 
Protocol: LUM-001, version 4.0 
CONFIDENTIAL 
 
Final 
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Statistical analyses 
The sample size estimation is based on a similar variable as the 
primary variable in this trial, i.e. the difference in contrast density in 
HU between bowel lumen and wall (mucosal lining), expressed as the 
mean of 9 measurement performed in the 5 selected sub-segments of 
the small bowel. At each measurement site, the equipment gives a 
mean value (given by the software of the X-ray equipment in 
Hounsfield Units) and a standard deviation (for the pixels in the 
Region of Interest, ROI). This mean value is from now on called 
“mean contrast density”.  
 
In order to reach a 78 % probability (power) to detect (i.e. get a two-
sided p-value less than 5 %) assuming a difference of 1.50 between 
the groups for the mean difference in contrast density and a standard 
deviation of 2.00 (assumptions based on an earlier trial, [1]) a total of 
40 fully evaluable is needed in the Lumentin group and 20 in each of 
the comparator groups, i.e. a total of 80 fully evaluable subjects 
 
The randomisation will be stratified by gender as the drinking 
capacity on average differs between males and females. 
 
Descriptive statistics will be used to describe the results. When testing 
the hypotheses of equality between the groups p-values (two-sided) 
will be calculated by means of the Wilcoxon rank sum test or Fisher’s 
exact test depending on the distribution of the variable of interest. 
 
 
 

Sponsor: Lument AB 
Clinical Trial Protocol 
Protocol: LUM-001, version 4.0 
CONFIDENTIAL 
 
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1.1 
Schedule of Events: 
a) 
No formal screening will be performed in the trial. However, since only one visit to the clinic is planned in 
this trial, all subjects will receive information regarding the trial prior to the clinic visit. Subjects will thus 
have time to consider participation and prepare questions, if needed. 
b) 
Also in case a subject is withdrawn after intake of the contrast agent the Early Termination form should be 
completed. 
c) 
Urine pregnancy test of all fertile females 
d) 
Blood sample (2 mL) will include Na, K, Ca, P in serum and will be taken prior to intake of contrast agents 
and post CT-scan.  
 
 
 
Visit/Contact 
0 
Screening a) 
1 
CT-scan 
2 
Telephone 
interview and early 
termination b) 
Day 
-28 to -1 
0 
1-2 
Visit window 
 
 
12-48 hours 
Subject information 
X 
X 
 
In/exclusion criteria 
 
X 
 
Informed consent 
 
X 
 
Pregnancy test c) 
 
X 
 
Randomisation 
 
X 
 
Subject demographics (incl. height and weight) 
 
X 
 
Concomitant treatment 
 
X 
X 
Concomitant illnesses 
 
X 
 
Medical history 
 
X 
 
Blood sample (clinical chemistry) d) 
 
X 
 
Adverse event(s) 
 
X 
X 
Dispensing of contrast agent 
 
X 
 
Administration of Iodine contrast 
 
X 
 
CT Scan 
 
X 
 
Evaluation of contrast difference 
 
X 
 
Evaluation of extension and distension 
composite score 
 
X 
 
Evaluation of diagnostic ability 
 
X 
 
Evaluation of contrast agent 
degradation  
 
X 
 
Subject assessment of taste, smell, 
consistency etc. 
 
X 
 
Compliance 
 
X 
 

Sponsor: Lument AB 
Clinical Trial Protocol 
Protocol: LUM-001, version 4.0 
CONFIDENTIAL 
 
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2 
LIST OF TRIAL PERSONNEL 
Sponsor 
Lument AB 
Scheelevägen 22 
Box 719 
SE-220 07 Lund 
Sweden 
Phone: 
+46 708 76 10 65 
E-Mail:  
olof.book@lumentab.com 
 
Clinical Project Manager 
Johan Quensel, CEO 
Phone: 
+46 760 46 97 44 
E-Mail:  
jq@qcrc.se 
 
Responsible Medical 
Officer 
Thomas Fork 
Phone: 
+46 705 33 69 96 
E-Mail:  
thomas.fork@lumentab.com 
Coordinating Investigator 
Dr. Peter Leander 
Verksamhetsområde Bild och funktion  
Skånes Universitetssjukhus 
Inga Marie Nilssons gata 49 
SE-205 02 Malmö 
Sweden  
 
Phone: 
 
 
+46 40 338910 
Mobile phone:  
+46 768 871069 
E-Mail: 
 
 
peter.leander@skane.se 
 
Contract Research 
Organization 1 
Responsible for monitoring 
Q Clinical Research Consulting AB 
Lärarvägen 12 
SE-247 45 Torna Hällestad 
Sweden 
Phone: 
+46 760 46 97 44 
E-Mail:  
jq@qcrc.se 
 
Monitor 
Johan Quensel 

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Protocol: LUM-001, version 4.0 
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Contract Research 
Organization 2 
Responsible for Serious 
Adverse Event (SAE) 
Management and Data 
Management 
  
 A+ Science AB 
Luntmakargatan 22  
SE-111 37 Stockholm  
Phone: 
+46 ( 735 24 04 26 
E-Mail:  info@a-plusscience.com  
Safety Medical Monitor 
Dr Janet Post +46 735 24 03 98 
Adverse Event Reporting 
Email: safety@a-plusscience.com (preferred) 
Fax: +46 8 28 41 22 
 
 
 

Sponsor: Lument AB 
Clinical Trial Protocol 
Protocol: LUM-001, version 4.0 
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3 
TABLE OF CONTENT 
1 
PROTOCOL SYNOPSIS ........................................................................................... 5 
1.1 
Schedule of Events: ................................................................................... 15 
2 
List of Trial Personnel ......................................................................................... 16 
3 
Table of content ................................................................................................. 18 
4 
List of Abbreviations and Definitions of Terms .................................................... 22 
5 
Background ........................................................................................................ 23 
5.1 
Introduction ............................................................................................. 23 
5.2 
Rationale .................................................................................................. 24 
5.3 
Risk-Benefit Assessment ........................................................................... 24 
6 
Trial Objectives .................................................................................................. 25 
6.1 
Primary Objective ..................................................................................... 25 
6.2 
Secondary Objectives ................................................................................ 25 
7 
Overall Design and Plan of the Trial .................................................................... 25 
7.1 
Overview .................................................................................................. 25 
7.2 
Parameters ............................................................................................... 27 
7.2.1 
Primary Efficacy Variable .............................................................................. 27 
7.2.2 
Secondary Efficacy Variables ........................................................................ 27 
7.2.3 
Safety Variables............................................................................................. 27 
7.3 
Justification of the Trial Design ................................................................. 27 
7.3.1 
Justification for Design and Parameters ....................................................... 27 
7.3.2 
Justification for Drug, Route, Dosage and Treatment Duration ................... 28 
8 
Trial Population ................................................................................................. 28 
8.1 
Inclusion Criteria ....................................................................................... 28 
8.2 
Exclusion Criteria ...................................................................................... 29 
8.3 
Subject Withdrawal and Replacement ....................................................... 29 
8.4 
Planned Sample Size and Number of Trial Centres ..................................... 30 
8.5 
Subject Identification and Randomisation ................................................. 30 
9 
INVESTIGATIONAL PRODUCTs ............................................................................. 31 
9.1 
Investigational products ............................................................................ 31 

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9.1.1 
Lumentin® 44 ................................................................................................. 31 
9.1.2 
Diluted Omnipaque® ..................................................................................... 32 
9.1.3 
Movprep® ...................................................................................................... 32 
9.2 
Administration .......................................................................................... 33 
9.3 
Packaging, Labelling and Storage ............................................................... 33 
9.4 
Blinding and Breaking the Blind ................................................................. 34 
9.5 
Drug Accountability .................................................................................. 34 
9.6 
Drug Exposure and Compliance ................................................................. 34 
9.7 
Concomitant Medications ......................................................................... 34 
10 Parameters and Methods of assessment............................................................. 35 
10.1 
Assessments of efficacy Parameters .......................................................... 35 
10.1.1 Relative mean difference in contrast density ............................................... 35 
10.1.2 Evaluation of ability to fill the bowel ............................................................ 36 
10.1.3 Diagnostic ability when examining Abd-CT .................................................. 37 
10.1.4 Degradation of contrast agents .................................................................... 38 
10.1.5 Ability to eat/drink the contrast agents ....................................................... 38 
10.1.6 CT-scan examination ..................................................................................... 39 
10.2 
Safety Parameters .................................................................................... 39 
10.2.1 Adverse Event ............................................................................................... 39 
10.2.2 Adverse Reaction .......................................................................................... 39 
10.2.3 Unexpected Adverse Reaction ...................................................................... 39 
10.2.4 Serious Adverse Event .................................................................................. 40 
10.3 
Reporting of Adverse Events ..................................................................... 40 
10.3.1 Severity ......................................................................................................... 41 
10.3.2 Causality ........................................................................................................ 41 
10.4 
Follow-up of Subjects after Adverse Events ............................................... 41 
10.5 
Abnormal Laboratory Values ..................................................................... 41 
10.6 
Reporting of Serious Adverse Events ......................................................... 42 
10.7 
Precautions/Overdose .............................................................................. 43 
11 Demographics and Baseline Characteristics ........................................................ 43 
11.1.1 Subject Demography ..................................................................................... 43 
11.1.2 Medical History ............................................................................................. 43 
12 Trial Conduct ...................................................................................................... 44 
12.1 
Procedures by Visit ................................................................................... 45 
12.1.1 Contact 0 (Screening, Day -28 to Day -1) ...................................................... 45 

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12.1.2 Visit 1 (CT-scan, Day 1) .................................................................................. 45 
12.1.3 Contact 2, Telephone interview .................................................................... 46 
13 Statistical Methods ............................................................................................ 46 
13.1 
Trial Subjects ............................................................................................ 46 
13.1.1 Disposition of Subjects .................................................................................. 46 
13.1.2 Protocol Deviations ....................................................................................... 46 
13.1.3 Analysis Populations ..................................................................................... 47 
13.2 
General Considerations ............................................................................. 47 
13.3 
Demographics, Baseline Characteristics and Concomitant Medications...... 47 
13.4 
Efficacy Analyses ....................................................................................... 47 
13.4.1 Primary Efficacy Analysis .............................................................................. 48 
13.4.2 Secondary Efficacy Analysis .......................................................................... 48 
13.4.3 Drug Exposure ............................................................................................... 48 
13.4.4 Validity and repeatability of the primary endpoint ...................................... 48 
13.4.5 Adverse Events .............................................................................................. 48 
13.5 
Interim Analyses ....................................................................................... 49 
13.6 
Determination of Sample Size ................................................................... 49 
13.6.1 Sample size (per group) ................................................................................ 49 
13.6.2 Sample Size Formula ..................................................................................... 49 
14 Ethical ................................................................................................................ 50 
14.1 
Independent Ethics Committee (IEC) ......................................................... 50 
14.2 
Ethical Conduct of the Trial ....................................................................... 50 
14.3 
Subject Information and Consent .............................................................. 50 
14.4 
Subject Data Protection ............................................................................ 50 
14.5 
Other Ethical and Regulatory Issues .......................................................... 51 
14.6 
Ethical Consideration statement ............................................................... 51 
15 DATA QUALITY ASSURANCE ................................................................................ 51 
15.1 
Quality Assurance ..................................................................................... 51 
15.2 
Trial Monitoring ........................................................................................ 52 
15.3 
Confidentiality .......................................................................................... 53 
15.4 
Source Data .............................................................................................. 53 
15.5 
Case Report Forms (CRFs) .......................................................................... 54 
15.6 
Data Management .................................................................................... 55 

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15.7 
Archiving Trial Records .............................................................................. 55 
16 trial MANAGEMENT ........................................................................................... 55 
16.1 
Time Schedule .......................................................................................... 55 
16.2 
Protocol Amendments .............................................................................. 55 
16.3 
Agreements .............................................................................................. 56 
16.4 
Duration of the Trial ................................................................................. 56 
16.5 
Completion of Trial ................................................................................... 56 
16.5.1 Trial Completion Procedures ........................................................................ 56 
16.6 
Liability and Insurance .............................................................................. 57 
16.7 
Use of information .................................................................................... 57 
16.8 
Publication Policy ..................................................................................... 57 
17 Reference List ..................................................................................................... 59 
18 Appendices ........................................................................................................ 60 
 
Appendices 
Appendix 1 Lument whipping protocol 
60 
Appendix 2 ”Protokoll för bedömning av kontrastdryckens egenskaper” 
67 
Appendix 3 ”Rapporteringsformulär inför uppföljningssamtal 12 - 48 timmar  
 
efter CT-undersökning” 
68 
 
Tables in Text 
Table 1 Lumentin® 44 Dispersion 
31 
Table 2: Omnipaque 240 mg I/mL 
31 
Table 3: Movprep® 
32 
Table 4: Schedule of Events 
44 
 
 
 

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4 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abd-CT 
Abdominal-CT 
ADR 
Adverse drug reaction 
AE 
Adverse event 
ATC 
Anatomical Therapeutic Chemical 
CI 
Confidence interval 
eCRF 
CT 
electronic Case report form 
Computed tomography 
DMF 
Drug Master File 
DRL 
Drug Reference List 
EWP 
Egg white protein (also referred to as egg albumen) 
FA 
Full analysis 
GCP 
Good Clinical Practice 
HU 
Hounsfield units 
ICH 
International Conference on Harmonization 
IEC 
Independent Ethics Committee 
IP 
Investigational Product 
ITT 
Intention-to-treat 
IV 
Intra Venous 
MRI 
Magnetic Resonance Imaging 
MedDRA 
Medical Dictionary for Regulatory Activities 
NSAID 
Non-steroidal anti-inflammatory drug 
Ph. Eur. 
European Pharmacopeia 
PP 
Per protocol 
ROI 
Region of Interest 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SD 
Standard deviation 
SUSAR 
Serious unexpected suspected adverse reactions 
TEAE 
Treatment-emergent adverse event 
V/V 
Volume per volume 
W/W 
Weight per weight 
WHO 
World Health Organization 
 
 
 

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5 
BACKGROUND 
5.1 
Introduction 
Subjects referred for examination with computed tomography, CT, of the abdomen are, 
according to clinical practice, prepared with an oral liquid contrast for demarcating loops 
of small bowel from surrounding tissues and abdominal and pelvic organ. Most often 
these oral contrast-agents are based on iodine, so-called positive contrast agent, which 
results in a bright bowel content, i.e. an intraluminal appearance with positive Hounsfield 
units, HU. Other options include iso-osmotic solutions based on either polyethylene 
glycol or Sorbitol / Mannitol, creating luminal densities near that of water, i.e. around 10-
20 HU, hence by rights denominated as neutral oral contrast agents. The rationale behind 
administering a neutral solution is to establish a boosted attenuation difference between 
the small bowel wall and its lumen, further increased by an intravenously administered 
iodine contrast. The amplified difference between small bowel wall and lumen might 
theoretically result in augmented conspicuity of the interface itself, thereby improving 
diagnostics of the mucosal lining and of lesions in the bowel wall and its proximity. This 
knowledge is implemented in CT protocols aiming at pancreatic cancer, where neutral 
contrast is recommended, especially in the papillary part of duodenum, in order to 
increase the probability of detection of small tumours. A high attenuation difference 
between small bowel lumen and mucosal lining is also a prerequisite for virtual 3D-
presentation of the small bowel, similar to CT-colonoscopy.  
An intensified small bowel wall is currently depicted on images acquired with magnetic 
resonance imaging, MRI, technique [2]. On a special MRI-sequence the small bowel 
lumen appears dark. After IV. gadolinium contrast administration, the small bowel wall 
with its mucosa stand out with increased signal intensity (bright), particularly in a case 
with inflammatory bowel disease. The induced contrast enhancement facilitates and 
improves diagnostics. Unfortunately, the availability of MRI equipment is limited 
compared to that of CT, and is therefore mostly reserved for young subjects with 
inflammatory bowel disease, for those who need repeated imaging, and for those with 
complicated diseases of the small bowel. Thus, most subjects with abdominal problems 
needing imaging are referred for abdominal-CT (Abd-CT). It would therefore be 
desirable to present CT-images with a dark small bowel lumen, as seen on certain MRI 
sequences. In order to allow for the odd and clinically silent small bowel lesion to be 
unveiled, a “black” bowel lumen would be advantageous in all subjects for Abd-CT. 
Scientists have been eager to pursue this idea since the 1980s. Furthermore, radiologists 
have for decades expressed a wish for a negative bowel contrast in order to improve 
diagnostics and tested several agents based on fat and bubbles. So far none has been 
clinically successful [3-12] while a number of side-effects were reported in association 
with oil-based contrasts such as abdominal cramps, diarrhoea and oily taste. Furthermore, 
many of these bowel filling agents have been denominated as being negative although 
they were assigned higher mean scores than water in each segment of the bowel, i.e. with 
positive HU. Still, the use of a neutral oral contrasts, with HU of around that of water, 
have been established in clinical routine due to improved CT-diagnostics.  

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5.2 
Rationale 
Lument AB have been successful in developing a food-based oral product, characterized 
by being a true negative CT-contrast agent by providing a density contrast down to minus 
600 HU. Necessary demands included in the research work were palatability (taste, smell 
and consistency), stability during its passage through the upper gastro-intestinal tract, and 
acceptable side effect profile. After approval from the local Ethical Committee (Dnr. 
2015/912) and Institute of Radiation Protection (Dnr. SSF02015-048) we successfully 
accomplished our first pilot clinical study [1] of abdominal CT examinations on healthy 
volunteers using a slightly different formulation containing 60% air as compared to the 
current formulation containing 44% air. The results showed that the foam provided true 
negative, black bowel lumen, from pylorus to cecum; good acceptance of the foam by the 
volunteers with only mild adverse events reported, and that the diagnostic reading of the 
CT-examination as a whole, with “black” loops of small bowel, was easily accepted by 
the radiologist. 
Lumentin® 44  
Lumentin® 44 is a novel, HU-negative contrast agent which is formulated as an aqueous 
dispersion containing less than 4% dry matter. The product consists of a continuous 
aqueous phase that contains egg white protein (EWP) as foaming agent, xanthan gum as 
stabilizer, phosphate salts as buffering agents, and flavouring.  
Prior to use, the product is whipped to a stable foam, containing 44% air, which is orally 
administered. The whipped, ready to use, Lumentin® 44 foam formulation is stable with 
suitable characteristics (air content, volume, bubble size, homogeneity, consistency, 
stability and palatability). A typical dose for an Abd-CT examination is 1000 ml ± 200 
ml taken orally over a period of 45 to 60 minutes.  
The air trapped in the foam is the radiological key ingredient that causes improved bowel 
lumen-to-wall contrast, with the interface at the surface of the mucosal lining of the 
bowel wall. The external demarcation of the small bowel from surrounding organs is on 
par with standard filling agents used in Abd-CT examinations of today.  
5.3 
Risk-Benefit Assessment 
All excipients in Lumentin® 44, expect EWP, are of pharmacopoeia quality (buffer and 
stabilizer) or belongs to a product range (flavor) registered under a Drug Master File 
(DMF) in the US, and widely used in pharmaceuticals. The EWP is widely used as a food 
ingredient. 
The side effects reported in the pilot trial, by volunteers drinking up to 1.4 L of the 
preliminary formulation (containing 60% air) were mild and hence it is considered that 
L60 were well tolerated. Most common side effects observed were eructation, abdominal 
distension, and mild nausea.  
Allergic reactions towards egg protein cannot be excluded and patients with a known 
sensitivity towards egg should not be exposed to Lumentin® 44.  
Ingestion of a large volume of foam in a short time may have an effect on the resorption 
pattern of concomitant medications. Intake of other medications, which are absorbed in 

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the small bowel, and having a narrow therapeutic window, should be avoided within a 
period of four hours before and until one hour after administration of Lumentin® 44. 
The patients in the planned trial are all referred for routine abdominal CT examination. 
No direct benefit is expected for patients receiving Lumentin® 44 in this trial compared 
to those receiving Omnipaque® or Movprep®. 
6 
TRIAL OBJECTIVES 
6.1 
Primary Objective 
To compare the mean difference in contrast density shown on abdominal CT-images 
when using the contrast agent Lumentin® 44, with abdominal CT-images using diluted 
Omnipaque® and with abdominal CT-images using Movprep® 
6.2 
Secondary Objectives 
• To describe and compare the ability of Lumentin® 44 to fill the bowel as compared to 
Movprep® and diluted Omnipaque®.  
• To describe and assess how Lumentin® 44 influences reading of the abdominal CT-
examination as compared to Movprep® and diluted Omnipaque® with respect to:  
o Diagnostics with particular regard to parenchymal organs, lymphatic 
system and tissue compartments beyond the gastrointestinal tract 
• To investigate signs of degradation of Lumentin® 44 in terms of  
o Coalesence 
o Syneresis or drainage 
• Describe and compare the ability to eat/drink for each of three contrast agents with 
respect to: 
o Taste 
o Smell 
o Consistency  
o Ability to swallow 
o Fullness 
• Validity and repeatability of the primary endpoint 
• To evaluate safety and tolerability after oral administration of each of three contrast 
agents  
7 
OVERALL DESIGN AND PLAN OF THE TRIAL 
7.1 
Overview 
An open, randomized, controlled, single centre phase 2 trial. 
Blinding of the trial is not possible due to the clear differences in the features and 
properties of the contrast agents. Thus, subjects will be able to identify the contrast agent 
through taste and consistency and the investigators will be able to identify which contrast 
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Subjects referred for abdominal or thoracoabdominal CT-examination will be invited by 
letter to participate in the study. This invitation is added to the referral letter that informs 
them on day and time for the CT-examination. Referral letters are routinely sent out 
within 4 weeks prior to the examination. All subjects who has received an invitation 
letter will be contacted by phone by a study nurse. Those subjects who are interested in 
participating will be forwarded a full subject information about the trial and they will be 
asked to read it prior to the CT-examination visit.  
Patients at the oncology departments at the hospital of Lund and Malmö will also be 
informed about the trial. Posters will be placed at the departments and invitation letters 
will be handed out to those interested. 
Subjects still interested in participating in the trial will, upon arrival to the clinic at the 
day of CT examination, be fully informed about the trial by the investigator and given 
opportunity to ask questions. Eligible subjects will sign the consent to participate form 
prior to randomisation and any treatment related procedures. 
Subject demography, medical history and concomitant medication will be recorded, and 
a clinical chemistry blood sample (2 mL) will be taken just prior to drinking the oral 
contrast agent.  
Lumentin® 44 is given in volumes of 750 mL to 1 200 mL and Omnipaque® and 
Movprep® is given according to the general praxis of care at the department 
“Verksamhetsområde Bild och funktion Skånes Universitetssjukhus”. At least 750 mL of 
Lumentin® 44 must be drunk. At least the recommended, according to the general praxis 
of care, volume of Omnipaque® and Movprep® must be drunk.  
The subjects will be asked to drink the solutions of oral contrast agents within one hour.  
Subjects not able to drink at least 750 mL of Lumentin® 44 or, at least the recommended 
dose of Omnipaque® and Movprep®; will be classified as major protocol violators and the 
subject will be excluded from all efficacy evaluations.  
During the time the subjects drink the contrast agent, the subjects will be asked to 
complete a questionnaire assessing taste, smell, consistency, fullness and ability to 
swallow the contrast agent. 
The CT-examination will be started within 10 minutes after the contrast agent has been 
drunk and the CT-examination lasts in average eight minutes.  
The CT-equipment comes with a moving table and a fixed gantry in which the X-ray 
tube is rotating with 2 revs per sec. The subject will be placed in supine on the table with 
hands-over-head, and prone for dedicated examination of the bowels. The table is then 
moved into the gantry for exposure of the abdomen. Before the examinations starts, an 
intravenous injection of an iodine based contrast medium (Omnipaque® 350 mg I/mL) is 
given in order to enhance any existing lesion or disease. The dose is adjusted to body 
weight and kidney function and is usually given in the range of 60 to 115 mL of 
Omnipaque® 350 mg I/mL. The dose and batch number of iodine will be noted in the 
eCRF.  
At contrast peak in the aorta, and an extra fixed delay of 50 seconds, altogether 
approximately one minute, exposure starts and the table moves ahead while the body part 
is continuously irradiated from the rotating X-ray tube. The whole procedure is finished 
within 10 seconds and images presented within 30 seconds. After a quality check of the 

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CT-examination and affirmation of the subject’s well-being, the subject is free to leave 
the CT-scanner.  
The subject shall remain at the clinic for at least 30 minutes post the intravenous 
injection of the iodine based contrast medium in case of the occurrence of sensitivity 
reaction. 
A post- examination clinical chemistry blood sample (2 mL) will be taken prior to the 
subject will be leaving the clinic and occurrence of any adverse events will be recorded.  
The subjects will thereafter be free to leave the clinic. 
For safety reasons, subjects will be contacted, within 12 to 48 hours after the examination 
by the investigator and asked about occurrence of any adverse event. No other follow-up 
is planned. 
7.2 
Parameters 
7.2.1 Primary Efficacy Variable  
The mean difference in contrast density in HU, expressed as the mean of 11 
measurements of contrast density differences between bowel lumen and wall (mucosal 
lining) performed in the selected 5 sub-segments of the small bowel. 
7.2.2 Secondary Efficacy Variables  
• Bowel filling properties (extension and distension) on Abd-CT in each of 5 selected 
sub-segments of the small bowel  
• Degradation (presence of bubbles and signs of sedimentation) on Abd-CT in each of 
5 sub-segments of the small bowel 
• Diagnostic ability on Abd-CT of the parenchyma, lymphatic system and tissue 
compartments beyond the gastrointestinal tract.  
• Subject assessments of taste, smell, consistency, ability to swallow and fullness after 
swallowing the contrast agent  
7.2.3 Safety Variables 
The safety parameters consist of: 
• Especially solicited adverse events (AEs), i.e. stomach ache, burping, letting go of 
wind, Nausea and sensation of fullness 
 
• Any treatment emerging adverse events  
• Any treatment emerging adverse drug reactions (ADR) 
• Safety laboratory evaluations (clinical chemistry) 
• The reasons for withdrawal from the trial 
7.3 
Justification of the Trial Design 
7.3.1 Justification for Design and Parameters 
This trial is designed to document the efficacy of Lumentin® 44 to show contrast 
difference between the small bowel lumen and the small bowel wall (mucosal lining) as 
compared to the comparators and to investigate safety. A parallel groups design has been 

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chosen as a cross-over design is considered both unethical, for reason of irradiation, and 
logistically impossible. 
Data from an explorative trial [1] clearly indicates that the foam provided bowel loops 
with a black lumen and a large difference in contrast density between the lumen and 
surrounding small bowel wall (mucosal lining). The diagnostic readability of CT-
examinations was highly accepted by the radiologists. The foam was also able to fill the 
small bowel from pylorus to cecum on par with routinely used contrast agents and was 
well accepted by the subject with no serious adverse events. The observed adverse events 
were all mild with no need to intervene. 
The primary efficacy variable has been defined to be able to observe the contrast 
difference between the small bowel lumen and the small bowel wall (mucosal lining) in 
the whole length of the small bowel. The ability of the contrast agent to fill the small 
bowel is therefore reflected in the primary efficacy variable. 
Secondary objectives have been chosen to investigate the safety profile, the filling 
property of the contrast agent, the stability of Lumentin® 44 after administration, the 
diagnostic potential and how the patients experience the contrast agents properties with 
respect to taste, smell etc. 
The trial is not designed to investigate Lumentin® 44 with respect to diseases of the small 
bowel. No patients eligible for this trial have a clinical suspicion of a bowel disorder, viz. 
the bowel contrast agents are only used for demarcating the small bowel on the CT-
scans. The use of Lumentin® 44 in this trial will thus not influence any diagnostic 
performance of bowel diseases. Future trial with Lumentin® 44 will be designed to 
investigate the diagnostic potential for small bowel disorder with Abd-CT. 
7.3.2 Justification for Drug, Route, Dosage and Treatment Duration 
Comparators used in the trial are both standard care treatment used for patients referred 
to abdominal CT-scan examinations.  
Subjects in a previous explorative trial [1] were given 0.9 -1.5 L foam to take orally and 
23 out of the 25 subjects could consume more than 0.9 L of the foam. The small bowel 
filling properties of the foam was on par with the normally used contrast agents, diluted 
Omnipaque® and Movprep®. A dose of 1 000 ml + 200 ml was therefore selected. 
Both route and treatment duration are according to standard praxis. 
8 
 TRIAL POPULATION 
The trial population will consist of subjects who are referred to CT-examination of the 
abdomen. The subjects must be able to provide written informed consent and meet all the 
inclusion criteria and none of the exclusion criteria. 
8.1 
Inclusion Criteria 
Subjects will be entered into this trial only if they meet all of the following criteria: 
1. Subjects of either gender at least 18 years at the time of signing the informed consent.  
2. Females must either present a negative pregnancy test or be surgically sterile 
(hysterectomy or tubal ligation) or postmenopausal (i.e. experienced 12 consecutive 
months without menstruation) 

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3. Having a clinical indication for CT-examination of the abdomen 
4. Having fasted (drinking allowed) for at least four hours prior to the intake of the 
contrast agent 
5. Patients participating in concurrent oncology trial must either participate in the 
follow up phase of the clinical trial and currently receive no trial drug treatment since 
at least 6 weeks, or receive a reduced maintenance dose of the trial treatment 
6. Following verbal and written information about the trial, the subject must provide 
signed and dated informed consent before any trial related activity is carried out. 
8.2 
Exclusion Criteria 
Subjects will not be enrolled if they meet any of the following criteria: 
1. IV administration of iodine is contraindicated 
2. Clinical suspicion, according to medical record, of fistula formation and/or leakage  
3. Having swallowing disorders preventing intake of the contrast agents 
4. Referral indication of small bowel disease(s) 
5. Known allergy to egg albumen 
6. Known sensitivity to any of the components of the investigational product or 
comparators 
7. Having known manifest thyrotoxicosis 
8. Having known phenylketonuria 
9. Having known Glucose-6-phosphatase deficiency 
10. Has taken any medication, absorbed through the small bowel, less than four hours 
before intake of the investigational product or comparators 
11. Being, in the opinion of the investigator, unlikely to comply with the clinical trial 
protocol 
12. Previously randomised to participate in this trial  
13. Participating in, or having participated in another, non-oncology clinical trial where 
the final trial treatment was given within the last 6 weeks 
14. Participating in an oncology clinical trial where the final full (i.e. non-maintenance) 
trial treatment was given within the last 6 weeks 
8.3 
Subject Withdrawal and Replacement 
Subjects may withdraw from the trial at any time and for any reason without prejudice to 
his or her future medical care. 
Subjects must be withdrawn under the following circumstances: 
• The subject withdraws consent, 
• The subject is unable to drink at least 750 mL of Lumentin® 44 or at least the lowest 
recommended dose, according to the general praxis of care at the department of 
“Verksamhetsområde Bild och funktion Skånes Universitetssjukhus”, of Omnipaque® 
and Movprep®  
• Violation of eligibility criteria 

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Subjects may be required to withdraw after discussion with the Sponsor and/or 
Investigator for the following reasons: 
• AEs, 
• Use of prohibited medication (see Section 9.7), 
• At the discretion of the Investigator, 
• Violation of eligibility criteria, 
In all cases, the reason(s) for withdrawal must be recorded on the eCRF. If a subject is 
prematurely withdrawn from the trial for any reason, the Investigator must make every 
effort to perform the evaluations described for the Early Termination Visit (see 
Section 12). 
If a subject has withdrawn informed consent and still agrees to attend the Early 
Termination Visit, this will be documented on the eCRF. 
For subjects who are withdrawn after they receive the trial drug, the Early Termination 
page will be completed in the eCRF.  
Subjects who are withdrawn from the trial will be provided care according to the 
judgement of the investigator. Normal praxis at the clinic is to perform the CT-scan even 
if the subject cannot consume the recommended volume of the contrast agent.  
Subjects who withdraw after randomisation will not be replaced. 
8.4 
Planned Sample Size and Number of Trial Centres 
It is planned to randomise 40 evaluable subjects to the Lumentin arm and 20 subjects to 
each of the Omnipaque and Movprep arms. To cover for a 10% drop out rate a total of 93 
subjects will be randomised.  
Randomisation will be terminated when 40:20:20 evaluable subjects are reached in 
respective arm. See Section 13.6 for a discussion of sample size. 
8.5 
Subject Identification and Randomisation 
Subjects referred to CT examination of the abdomen will receive an invitation to the CT 
examination by letter. An advertisement letter informing about the trial will be included 
in this referral letter. 
All referrals for abdominal CT are read and prioritized by the investigator/sub-
investigator. Those subjects, irrespective from which medical clinic, who the radiologist 
think are possible candidates for the trial, will have the advertisement letter added to the 
referral letter sent home to them with date and time for their CT-examination.  
An invitation log will be kept with names of those receiving the advertisement letter. 
Subjects will subsequently be contacted by and asked if they are interested in 
participation. Those interested will be sent the subject information leaflet.  
All subjects receiving the patient information leaflet will receive a screening number 
consisting of S followed by three digits: S-XXX starting with S-101. 
The Investigator will allocate the screening numbers in ascending order. 
Enrolled subjects who drop out of the trial before randomisation will retain their 
screening number.  

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Randomisation will occur at the clinic on the day of examination when all screening 
procedures have been performed and eligibility for the trial confirmed. Each randomised 
subject will receive a unique randomisation number consisting of R followed by three 
digits: R-XXX stating with R-101. Randomisation numbers will be allocated in strict 
ascending order according to a randomisation list  
Randomised subjects who terminate their trial participation for any reason, regardless of 
whether trial drug was taken or not, will retain their randomisation number. 
Subjects will be randomised on a 1:1:1 basis to Lumentin® 44, diluted Omnipaque® or 
Movprep®. The randomisation will be in blocks and stratified by gender as the drinking 
capacity differs between males and females. 
 
9 
INVESTIGATIONAL PRODUCTS 
9.1 
Investigational products  
9.1.1 Lumentin® 44  
Lumentin® 44 Dispersion will be manufactured and released by Bioglan AB, Borrgatan 
31, 202 13 Malmö, Sweden. 
Table 1: Lumentin® 44 Dispersion 
Ingredients 
Lumentin® 44 Dispersion 
Concentration (g/100g) 
Egg White Powder 
1.93 
Sodium dihydrogen phosphate dihydrate 
(NaH2PO4 • 2H2O) 1 
0.19 
Dibasic potassium phosphate (K2HPO4) 1 
0.63 
Xanthan gum 1 
0.48 
Flavour 2 
0.24 
Water, purified 1 
96.53 
1) Ph. Eur.: European Pharmacopeia 
2) The flavour mixture contains vanillin, Propylene Glycol (E1520) and water and 
belongs to a product range registered under a DMF in the US. 
 
Lumentin® 44 Foam 
The final preparation of the investigational product, Lumentin® 44, will be performed at 
the clinic, see appendix 1, Lumentin® 44 dispersion whipping protocol 
Lumentin® 44 contains the exact same ingredients as Lumentin® 44 Dispersion, see table 
1, except for added air due to the whipping process. 
 

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9.1.2 Diluted Omnipaque® 
Omnipaque® 240 mg I/mL is manufactured by GE Healthcare AS, Nycoveien 1-2, P.O. 
Box 4220 Nydalen, N-0401 Oslo, Norge. 
 
Table 2: Omnipaque® 240 mg I/mL  
Ingredients 
Concentration (mg/mL) 
Iohexol 
518 
 
Iodine equivalent 
240 
Tromethamine 
1.21 
Edetate calcium disodium 
0.1 
Hydrochloric acid 
 1 
Sodium hydroxide 
 1 
1 For pH adjustment only 
 
Diluted Omnipaque® 
30 ml of Omnipaque® 240 mg I/mL will be mixed with 970 ml water. 
The final preparation of the investigational product, diluted Omnipaque®, will be 
performed at the clinic.  
 
9.1.3 Movprep® 
Movprep® is distributed by Norgine BV, Hogehilweg 7, 1101CA, Amsterdam ZO, The 
Netherlands.  
Movprep® is distributed as two dose units, Unit A and Unit B. 
 Table 3: 
Movprep®  
Ingredients 
Content (g) 
Unit A 
- 
- 
Macrogol 3550 
100 
- 
Sodium Sulphate, waterfree 
7.500 
- 
Sodium Chloride 
2.691 
- 
Potassium Chloride 
1.015 
Unit B 
- 
- 
Ascorbic Acid 
4.700 
- 
Sodium Ascorbate 
5.900 
 
Preparation of Movprep® 

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Dose Units A and B are dissolved in 1000 ml water.  
The final preparation of the investigational product, Movprep® will be performed at the 
clinic.  
9.2 
Administration  
The Investigational products will be taken orally by the subject during a period of 30 
minutes - 1 hour.  
 
Lumentin® 44 
A volume of 1000 ml ± 200 ml shall be consumed. A steady intake rate of the contrast 
agent is recommended and the time period of intake should be 45 minutes - 1 hour.  
The subject will be withdrawn from the trial if the maximum volume of the 
Investigational product taken by the subject is less than 750 mL.  
There is no risk of overdose. 
 
Diluted Omnipaque® and Movprep® 
The volume of Omnipaque® and Movprep® consumed will be according to the standard 
of care praxis at the department of “Verksamhetsområde Bild och funktion  
Skånes Universitetssjukhus”. A steady intake rate of the contrast agent is recommended, 
and the time period of intake should be 30 minutes – 1 hour.  
The subject will be withdrawn from the trial if the maximum volume of the 
Investigational product taken by the subject is below the recommended dose.  
9.3 
Packaging, Labelling and Storage 
The Lumentin® 44 dispersion will be filled in 1.5L PET jars with white plastic screw-
caps at Bioglan AB. The head-space above the dispersion will be filled with Argon gas, 
which is an inert gas that acts as preservative due to its antioxidant and antimicrobial 
properties. 
The jars will be packed in aluminium laminated plastic bags which will be filled with 
argon and immediately sealed. The containers in their outer bags will be placed in a 
cardboard box to protect them during transport and storage. 
All Lumentin® 44 dispersion supplies must be stored and transported under 2-8°C. 
Lumentin® 44 dispersion will be transported to the site upon request. Until final 
preparation and dispensing to the subjects, the Lumentin® 44 dispersion will be stored in 
a refrigerator, accessible to authorised personnel only. 
Omnipaque® 240 mg I/mL and Movprep® will be stored in room temperature in a 
restricted area, accessible to authorised personnel only. 
 
Packaging and labelling of the contrast agents will be performed by Bioglan AB in 
accordance with applicable regulatory requirements.  

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9.4 
Blinding and Breaking the Blind 
Not Applicable. The trial is an open label trial.  
9.5 
Drug Accountability 
The Investigator is responsible for maintaining accurate investigational product 
accountability records throughout the trial. 
Each dispensing of investigational product will be documented in the drug accountability 
log and the eCRF. 
The height of the Lumentin® 44 foam in the PET jar will be measured prior to dispensing 
it to the subjects. The weight of all three contrast agents will be measured prior to 
dispensing as well as after intake. Height and weights will be and noted in the eCRF 
Drug accountability will be carried out at regular intervals, as specified in the monitoring 
plan. 
All unused investigational product (Lumentin® 44 dispersion) will be returned to Bioglan 
AB for destruction at the end of the trial. The Sponsor will be provided with the 
documentation of destruction of unused investigational product. 
9.6 
Drug Exposure and Compliance 
All containers will be weighed before they are dispensed to the subject and again when 
returned by the subject and these weights (in gram) will be recorded in the eCRF. 
Drug exposure will be estimated based on the weight of ingested contrast agent and the 
weight of the subject.  
Data from this trial will be used to the extent possible for providing future advice as of 
how much Lumentin® 44 should be used in order to obtain CT-scan with good diagnostic 
readability. 
The subject may be withdrawn from the trial if his/her wellbeing is jeopardised during 
intake of the contrast agent. The subject must be withdrawn if less than 750 mL of 
Lumentin® 44, or less than the, according to the general praxis of care, recommended 
dose of Omnipaque® and Movprep® can be consumed.  
Details and procedures in case of subject withdrawal are described in Section 8.3. 
9.7 
Concomitant Medications  
Concomitant Medication 
Any medication the subject takes other than the investigational product (prescribed and 
over-the-counter-drugs) is considered a concomitant medication. All concomitant 
medications must be recorded in the eCRF. The following information must be recorded 
in the eCRF for each concomitant medication: generic name, route of administration, 
start date, stop date, dosage, and indication. Any changes in the dosage or regimen of a 
concomitant medication must be recorded in the eCRF. 
At visit 1, CT-scan, subjects will be asked what medications they have taken during the 
last 2 weeks before visit 1, CT-scan. 

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At the contact 2, telephone interview, subjects will be asked what concomitant 
medications they are currently taking or have taken since they left the clinic. 
 
All subjects will receive an intravenous injection of an iodine based contrast medium 
(Omnipaque® 350 mg I/mL) during the CT-scan examination. This is a standard of care 
procedure for all subjects undergoing a CT-scan at the clinic and is as such not part of the 
trial protocol defined procedures. The dose will be adjusted to body weight and kidney 
function and is usually given in the range of 60 to 115 ml of Omnipaque® 350 mg I/mL. 
The dose given and batch number of the Omnipaque® 350 mg I/mL will be noted in the 
eCRF.  
Prohibited Previous and Concomitant Medication 
All use of medication taken by oral route will be prohibited during 4 hours before taking 
the contrast agents and one hour post the intake.  
All other medication taken by other routes are allowed.  
10 PARAMETERS AND METHODS OF ASSESSMENT 
10.1 Assessments of efficacy Parameters 
10.1.1 Mean difference in contrast density 
The contrast will be assessed by both the investigator and the sub-investigator, 
independently of each other, in the small bowel and expressed in Hounsfield Units (HU).  
The difference in contrast density between lumen and wall (mucosal lining) will be 
measured in 9 locations of the small bowel as described below.  
The small bowel is divided in 5 sub-segments and defined as follows: 
− Duodenum is defined as the first part of small bowel down to ligament of Treitz; 
− Jejunum identified by its typical feathery mucosal pattern on Abd-CT 
− The small bowel between the jejunum and terminal ileum is visually divided into two 
parts: 
o Proximal ileum is approximately defined as 30 cm / 4 loops of small 
bowel following jejunum  
o Distal ileum is approximately 30 cm / 4 loops proximal to terminal ileum  
− Terminal ileum is defined as the last 15 cm of ileum mounding into the ileo-cecal 
valve  
The difference in contrast density is measured in two sites in each of 4 of the defined 
sub-segments: duodenum, jejunum, proximal ileum, and distal ileum, and in the terminal 
ileum where (due to its shortness in length) only one site is selected.  
 
Two regions of interest (ROI) measuring 6 mm in diameter will be selected by the 
investigator in the lumen of each segment except in the terminal ileum where only one 
region is selected. The ROIs will be placed where the lumen is best shown in the CT-
image. The CT-scan software will provide a mean HU measurement of each of the 
selected ROIs and the values will be recorded by the investigator.  

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The HU of the wall will be set to +80HU as a standard for all measurements. It is not 
possible to discriminate between the lumen and the wall when Movprep® and Diluted 
Omnipaque® is used as contrast agents as they have a contrast similar to the wall 
contrast. 
 
In each segment, the difference in contrast density between bowel lumen and wall will be 
calculated by subtracting the pin point HU value(s) of the wall (set to +80HU) from the 
mean ROI HU value(s) of the lumen. Two differences in contrast density values will thus 
be generated for each segment except in the terminal ileum where only one value is 
generated. 
 
Each examination produced in the CT-scanner consist of more than 1 000 images which 
are stored in the patient’s medical record. The investigator and the sub-investigator will 
independently select the best images on which contrast differences are calculated. 
Screen-shots of all selected images will clearly identify sites of ROIs in the images, and 
an electronic footprint of storage time will be included in images when saved. Each 
image will also be uniquely identified by the CT-scanner’s software. The images unique 
code and the time point they are saved will be entered in the eCRF, in order to document 
that the investigators are assessing the images independently. The investigators will also 
be given unique access codes to the eCRF so that they cannot access each other’s 
assessment data. 
 
The mean difference in contrast density in the small bowel is the sum of the differences 
in contrast density values (9 calculated values based on the observation of the 
investigator and 9 based on the sub-investigator observations, ie. in all 18 observations) 
divided by 18. All segments to which the contrast agent has not reached and thus, the 
contrast cannot be measured will not be included in the mean difference.  The sum of the 
differences will in this case be divided by the number of measurable observations. The 
ability to fill the bowel will be investigated as a secondary objective, see below section 
10.1.2.   
 
 
10.1.2 Evaluation of ability to fill the bowel  
The bowel filling agent will be distributed along the length of small bowel, i.e. the 
extension, but also cause a local widening of the bowel loop, distension. The filling of 
each of the 5 selected sub-segments of the small bowel in terms of extension and 
distension will be examined on the CT-scan by both the investigator and the sub-
investigator, independently of each other, and graded using Likert scales between 1 and 
9.  
Subjects will be asked to fast for at least 4 hours prior to the intake of the contrast. The 
probability of the contrast agent to reach the terminal ileus is improved if the subject 
arrives fasted. Subject will be allowed to drink during the 4 hours. 

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The time point of assessment will be noted in the eCRF for both the investigator and the 
sub-investigator to document that the assessment has been done independently. 
Extension scale:  
1. no sign of contrast agent;  
2. trace of contrast agent filling 
3. segment filled to ca. 25% 
4. segment filled to >25% but <50% 
5. filled to segment filled to 50%  
6. segment filled > 50% but <75% 
7. segment filled to ca. 75% 
8. segment filled to >75% but <100% 
9. segment filled to 100% 
The Extension score will be the sum of the grades both assessors and in each sub-
segment and hence range from 10 to 90. 
 
Distension scale:  
1. no identifiable contrast agent 
2. a minimal amount of contrast agent is identified 
3. small amount of contrast agent, insufficient for placing a ROI of 6 mm 
4. amount of contrast agent just allowing for a ROI of 6 mm 
5. medium filled bowel loop 
6. slightly better than grade 5 
7. good filling 
8. optimal filling 
9. excellent or almost overdistended 
The Distension score will be the sum of the grades both assessors and in each sub-
segment and range from 10 to 90.  
10.1.3 Diagnostic ability when examining Abd-CT 
Diagnostic ability when examining Abd-CT will be assessed on the CT-scan by both the 
investigator and the sub-investigator, independently of each other. 
The following features will be assessed: 
− Small bowl appearance 
− parenchymal organs, i.e. pancreas, ovaries, urinary bladder 
− mesenterium and oment  
using a Likert scales of 1-9 ranging, where:  

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1. impossible to observe details  
 
5. medium 
 
9. excellent resolution  
The Diagnostic ability score will be the sum of the scores from both assessors and range 
from 6 to 54.  
The time point of assessment will be noted in the eCRF for both the investigator and the 
sub-investigator to document that the assessment has been done independently. 
 
10.1.4 Degradation of contrast agents 
Degradation of Lumentin® 44 is founded on the two characteristics Coalesence and 
syneresis or drainage. 
 
Coalesence: 
 
0. No bubbles visually detectable at the CT-scan 
 
1. Bubbles visually detectable at the CT-scan 
 
Syneresis or drainage: 
 
0.  No syneresis or drainage, i.e. separation of air and liquid 
 
 
phases, observed 
 
1. Syneresis or drainage observed 
Sign of degradation will be assessed on the CT-scan, by both the investigator and the 
sub-investigator, independently of each other, in each of the 5 selected sub-segments of 
the small bowel. 
Degradation of contrast agents score will be the sum of the scores from both assessors 
and in each sub-segment and range from 0 to 20. 
The time point of assessment will be noted in the eCRF for both the investigator and the 
sub-investigator to document that the assessment has been done independently. 
 
10.1.5 Ability to eat/drink the contrast agents 
Subjects will assess taste, smell, consistency, ability to swallow and fullness on a five 
degree-scale: 
6. Very negative/Very difficult/very full 
7. Negative/difficult/ full 
8. Neutral/medium/medium full 
9. Positive/easy/barely full 
10. Very positive, good/very easy/not at all full. 
Subjects will be handed an assessment form, see appendix 2, to be filled out during the 
period when the contrast agents are consumed. 

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10.1.6 CT-scan examination 
The CT-examination will be started within 10 minutes after the contrast agent has been 
consumed and the CT-examination as a whole lasts in average eight minutes.  
The CT-equipment comes with a moving table and a fixed gantry in which the X-ray 
tube is rotating with 2 revs per sec. The subject will be positioned in supine on the table 
with hands-over-head, and prone for dedicated examination of the bowels. The table is 
then moved into the gantry for exposure of the abdomen. Before the examinations starts, 
an intravenous injection of an iodine based contrast medium (Omnipaque 350 mg I/mL) 
is given in order to enhance any existing lesion or disease. The dose is adjusted to body 
weight and kidney function and is usually given in the range of 60 to 115 ml of 
Omnipaque 350 mg I/mL. The dose and batch number of iodine will be noted in the 
eCRF.  
At contrast peak in the aorta, and an extra fixed delay of 50 seconds, altogether 
approximately one minute, exposure starts and the table moves ahead while the body part 
is continuously irradiated from the rotating X-ray tube. The whole procedure is finished 
within 10 seconds and images presented within 30 seconds.  
A quality check of the CT-examination images is performed (in rare cases at the 
discretion of the X-ray nurse a second exposure is performed if the quality is poor) and 
affirmation of the subject’s well-being, the subject is free to leave the CT-scanner.  
10.2 Safety Parameters 
10.2.1 Adverse Event 
Any untoward medical occurrence in a subject or clinical trial subject administered a 
medicinal product and which does not necessarily have a causal relationship with this 
treatment. 
Comment: An AE can therefore be any unfavourable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease temporally associated with the use of 
an investigational medicinal product, whether or not considered related to the 
investigational medicinal product. 
10.2.2 Adverse Reaction 
All untoward and unintended responses to an investigational medicinal product related to 
any dose administered. 
Comment: All AEs judged by either the reporting Investigator or the Sponsor as having a 
reasonable causal relationship to a medicinal product qualify as adverse reactions. The 
expression reasonable causal relationship means to convey in general that there is evidence 
or argument to suggest a causal relationship. 
10.2.3 Unexpected Adverse Reaction 
An adverse reaction, the nature or severity of which is not consistent with the applicable 
product information (e.g. IB for an unauthorised IP or summary of product characteristics 
for an authorised product). 

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Comment: When the outcome of the adverse reaction is not consistent with the applicable 
product information this adverse reaction should be considered as unexpected. 
10.2.4 Serious Adverse Event 
Any untoward medicinal occurrence or effect that at any dose: 
• Results in death 
• Is life-threatening 
• Requires hospitalisation or prolongation of existing hospitalisation 
• Results in persistent or significant disability or incapacity 
• Is a congenital anomaly or birth defect 
Comments: Life-threatening in the definition of an SAE or serious adverse reaction refers 
to an event in which the subject was at risk of death at the time of event; it does not refer 
to an event which hypothetically might have caused death if it was more severe. 
Medical judgement should be exercised in deciding whether an AE/reaction is serious in 
other situations. Important AEs/reactions that are not immediately life-threatening or do 
not result in death or hospitalisation but may jeopardise the subject or may require 
intervention to prevent one of the other outcomes listed in the definition above, should 
also be considered serious. 
10.3 Reporting of Adverse Events 
All trial subjects will be carefully monitored for the occurrence of AEs during the trial 
period, from start of intake of the first dose until the contact 2, telephone interview 12 – 
48 hours after the CT-examination. Reported AEs will be followed up (see 10.4 below). 
The Investigator will collect AEs with a non-leading question such as “have you 
experienced any new health problems or worsening of existing conditions” as well as 
reporting events directly observed or spontaneously volunteered by subjects. 
Clearly related signs, symptoms and abnormal diagnostic procedure results should be 
grouped together and reported as a single diagnosis or syndrome whenever possible. 
All AEs including but not limited to events reported by the subject, or reported in answer 
to an open question by the Investigator or member of this team, which fall into any of the 
above definitions must be recorded as an AE in the eCRF and should include the following 
information: 
• Brief description of the event (diagnosis) 
• Start date (and time, if relevant) 
• Stop date (and time, if relevant) (or resolution) 
• Severity 
• Action taken regarding trial treatment 
• Opinion on causality 

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• Seriousness 
• Outcome 
10.3.1 Severity 
Severity describes the intensity of an event, and will be assessed as: 
Mild: 
The AE does not interfere in a significant manner with the subject’s normal 
functioning level. It may be an annoyance. 
Moderate: 
The AE produces some impairment of function but not hazardous to health. 
It is uncomfortable and/or an embarrassment. 
Severe: 
The AE produces significant impairment of functioning or incapacitation 
and/or it is a hazard to the subject. 
If an AE changes in severity, the worst severity should be reported. 
10.3.2 Causality 
Causality will be assessed as: 
Probable: 
A clinical event, including laboratory test abnormality, with a reasonable 
time sequence to administration of the drug, unlikely to be attributed to 
concurrent disease or other drugs or chemicals, and which follows a 
clinically reasonable response on withdrawal (dechallenge). Rechallenge 
information is not required to fulfil this definition. 
Possible: 
A clinical event, including laboratory test abnormality, with a reasonable 
time sequence to administration of the drug, but which could also be 
explained by concurrent disease or other drugs or chemicals. Information 
on drug withdrawal may be lacking or unclear. 
Unlikely: 
A clinical event, including laboratory test abnormality, with a temporal 
relationship to drug administration which makes a causal relationship 
improbable, and in which other drugs, chemicals or underlying disease 
provide plausible explanations. 
10.4 Follow-up of Subjects after Adverse Events 
AEs that are serious or those that the investigator assesse as relevant to follow from a trial 
perspective will be followed until they are recovered, stabilized or recovered with 
sequelae. The date and outcome will be recorded on the AE form in the eCRF. Other 
ongoing AEs will not be followed within the trial after the date of the contact 2, telephone 
interview. 
10.5 Abnormal Laboratory Values 
The reporting of abnormalities as both laboratory findings and AEs should be avoided. 
An asymptomatic abnormal laboratory finding should only be reported as an AE if it is 
clinically significant. 

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Clinically significant abnormal findings noted before treatment start at Visit 1 will be 
recorded on the medical history page in the eCRF. New or worsening clinically significant 
abnormal findings will be recorded on the AE page in the eCRF. 
If an abnormal laboratory value is associated with clinical signs and symptoms, the 
sign/symptom should be reported as an AE and the associated laboratory result should be 
considered additional information. 
10.6 Reporting of Serious Adverse Events 
The Investigator is responsible for ensuring that all SAEs are reported to the Sponsor or 
the sponsor’s designee immediately, by e-mail (preferred) or fax, but in any event no later 
than 24 hours of any site staff becoming aware of the event. Initial notification should be 
followed as soon as possible by detailed written reports. The initial and follow-up reports 
should identify subjects by unique code numbers assigned in the trial and not by the 
subjects’ names, personal identification numbers, and/or addresses. The following 
information is mandatory for the initial report: 
• Subject trial identification data (ID) 
• Trial treatment 
• Start date (time, if relevant) of the trial treatment 
• Brief description of the event (diagnosis) 
• Start date (time, if relevant) of the event 
• Seriousness criteria 
• Causality assessment 
For reported deaths, the Investigator should supply the Sponsor with any additional 
requested information (e.g. autopsy reports and terminal medical reports). 
SAE REPORTING CONTACT DETAILS 
A+ Science AB 
Dr Janet Post Medical Director 
  
E-mail: safety@a-plusscience.com (preferred) 
Fax : +46 8 28 41 22 
Phone: +46 735 24 03 98  
 
The Sponsor is responsible for informing the Competent Authorities, the European 
Medicines Agency (EMA) and Ethics Committees of any individual case reports of SAEs 
that are determined to be reportable by the sponsor (i.e. adverse events considered as 
serious, related and unexpected [SUSARs]). SUSARs will be distributed by the Sponsor’s 

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pharmacovigilance team within 7/15 working days to the EMA (EudraVigilance) and 
concerned Competent Authorities and Ethics Committees, according to local regulations. 
The investigator will be notified of safety issues/SUSARs according to current legislation. 
10.7 Precautions/Overdose 
Risks associated with intake of oral contrast agents include dysphagia with aspiration and 
secondary pneumonia. Although patients with acute problems are excluded, a pre-
emergency small bowel status might be aggravated to an established ileus by ingesting a 
large volume. Oral contrast agents should not be given to subconscious patients, to those 
with swallowing disorders, or an acute abdomen.  
Known sensitivity or allergy to contrast agent ingredients are exclusion criteria in clinical 
studies. However, unknown sensitivities or allergies might cause reactions that may need 
to be medically treated.  
Iodine may be absorbed and causes disturbance of functional test of the thyroid gland for 
weeks.  
 
Intravenously administered iodine may cause allergic reaction of various severity from a 
mild rush to intensive care unit treatment. Routines for handling these cases are well 
known to the staff which is regularly trained in dealing with emergency cases. Equipment 
for emergency care treatment is available at the clinic and the clinic is located in close 
proximity to the hospital emergency care department. 
11 DEMOGRAPHICS AND BASELINE CHARACTERISTICS 
Demographics and Baseline Characteristics consist of those parameters that are assessed 
only at screening/baseline. 
11.1.1 Subject Demography 
Subject demography consists of: 
• Date of birth, 
• Height, 
• Weight, 
• Sex 
The body weight will be measured with standard scales, and the subject will be asked 
about height, at Visit 1, CT-scan. 
11.1.2 Medical History 
For the documentation of the medical history, any previous and concomitant diseases 
within the last 2 years before screening will be documented in the eCRF. 
The medical history will be obtained by asking the subject and by inspecting his/her 
medical records if available. 
For statistical analysis, all previous and concomitant diseases will be coded with Medical 
Dictionary for Regulatory Activities (MedDRA), the version of which will be provided 
in the trial report. 
 
 

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12 TRIAL CONDUCT 
Table 4 
Schedule of Events 
a) 
No formal screening will be performed in the trial. However, since only one visit to the clinic is planned in 
this trial, all subjects will receive information regarding the trial prior to the clinic visit. Subjects will thus 
have time to consider participation and prepare questions, if needed. 
b) 
Also in case a subject is withdrawn after intake of the contrast agent the Early Termination form should be 
completed. 
c) 
Urine pregnancy test of all fertile females 
d) 
Blood sample (2 mL) will include Na, K, Ca, P in serum and will be taken prior to intake of contrast agents 
and post CT-scan.  
Visit/Contact 
0 
Screening a) 
1 
CT-scan 
2 
Telephone 
interview and early 
termination b) 
Day 
-28 to -1 
0 
1-2 
Visit window 
 
 
12-48 hours 
Subject information 
X 
X 
 
In/exclusion criteria 
 
X 
 
Informed consent 
 
X 
 
Pregnancy test c) 
 
 
 
Randomisation 
 
X 
 
Subject demographics (incl. height and weight) 
 
X 
 
Concomitant treatment 
 
X 
X 
Concomitant illnesses 
 
X 
 
Medical history 
 
X 
 
Blood sample (clinical chemistry) d) 
 
X 
 
Adverse event(s) 
 
X 
X 
Dispensing of contrast agent 
 
X 
 
Administration of Iodine contrast 
 
X 
 
CT Scan 
 
X 
 
Evaluation of contrast difference 
 
X 
 
Evaluation of extension and distension 
composite score 
 
X 
 
Evaluation of diagnostic ability 
 
X 
 
Evaluation of contrast agent 
degradation  
 
X 
 
Subject assessment of taste, smell, 
consistency etc. 
 
X 
Compliance 
 
X 
 

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12.1 Procedures by Visit 
Visits should occur within the time windows specified in the schedule of events, Table 4. 
All times should be recorded using the 24-hour clock (e.g., 23:20, not 11:20 pm). 
12.1.1 Contact 0 (Screening, Day -28 to Day -1) 
Contact 0 (Screening) will take place up to 28 days before Visit 1. 
Subjects referred for abdominal- or thoraco-abdominal CT-examination will be invited 
by letter to participate in the study. Referral letters that informs them on day and time for 
the CT-examination are routinely sent out within 4 weeks prior to the examination. The 
invitation is added to the referral letter together with the full subject information about 
the trial. Subjects that are interested in participating in the trial will be asked to contact 
the investigator. If the subject has not contacted the clinic a week before the examination 
the investigator will contact the subject to confirm if the subject is willing to participate 
or not. 
During the screening period, the Investigator will: 
• Provide the subject with an invitational letter providing information about the trial 
• Document subjects interest of participation in the trial by entering interested subjects 
to the screening log, 
• Provide interested subjects with full subject information by sending out subject 
information leaflet, 
• Answer any questions the subject might have regarding the trial 
12.1.2 Visit 1 (CT-scan, Day 1) 
Subjects still interested in participating in the trial will, upon arrival to the clinic at the 
day of CT examination, be fully informed about the trial by the investigator and given 
opportunity to ask questions. Eligible subjects will sign the consent to participate form 
prior to randomisation and any treatment related procedures. 
During Visit 1 the Investigator will: 
• Provide the subjects with full subject information and answer any question the subject 
might have 
• Obtain informed consent 
• Check in-/exclusion criteria 
• Randomise the subject 
• Record demography parameters 
• Record concomitant medication and illness 
• Record medical history 
• Take blood sample (2 mL) before and after contrast agent administration 
• Dispense the contrast agent 
• Record the subject’s assessment of taste, smell, consistency etc. 
• Check and record compliance 
• Note adverse events 
• Perform the CT-scan including providing iodine contrast agent 
• Assess efficacy  

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12.1.3 Contact 2, Telephone interview 
The subject will be contacted by telephone by the investigator 12 to 48 hours after the 
CT-scan visit and interviewed about any possible adverse events that has occurred during 
the period after the CT-scan. The interview will include a set of predefined questions (see 
appendix XX) and also an open question, e.g. “have you experienced any untoward 
events or side effects since you left the clinic”. Concomitant medication and any change 
in concomitant medication will also be checked. 
During telephone interview, the Investigator will: 
• Check any occurrence or change in adverse events 
• Check of use or change in concomitant medication 
SAE and other AEs that the investigator assesses as relevant to follow from a trial 
perspective will be followed up, see section 10.4  
13 STATISTICAL METHODS 
Before disclosure of randomisation codes, a separate statistical analysis plan (SAP) may 
be finalised, providing detailed methods for the analyses outlined below.  
In general, data summaries will be stratified by the randomised treatment group 
(Lumentin® 44, diluted Omnipaque® and Movprep®). The randomisation is stratified by 
gender and this will be taken into consideration in the statistical analyses  
Any deviations from the planned analyses will be described and justified in the final 
integrated trial report. 
13.1 Trial Subjects 
13.1.1 Disposition of Subjects 
The number and percentage of subjects will be presented, stratified by treatment and 
overall, with sub-stratification by randomisation stratification factors.  
Reasons for withdrawal will also be summarised. 
13.1.2 Protocol Deviations 
Deviations to the trial protocol will be documented in a Protocol Deviation Log. 
Deviations from the protocol including violations of inclusion/exclusion criteria will be 
assessed as “minor” or “major” on a case-by-case basis in cooperation with the Sponsor. 
This assessment will take place during a data review meeting. Major deviations from the 
protocol will lead to the exclusion of a subject from the per protocol analysis set.  
Unless decided otherwise during the data review meeting, the following will be major 
protocol deviations: 
• Deviations of inclusion/exclusion criteria, 
• Subjects not able to drink at least 750 mL Lumentin® 44  
• Subjects not able to drink at least the, according to the general praxis of care, 
recommended dose of diluted Omnipaque® 
• Subjects not able to drink at least the, according to the general praxis of care, 
recommended dose of Movprep® 

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13.1.3 Analysis Populations 
Safety set: 
All subjects who received at least some portion of the contrast agents 
(Lumentin® 44, diluted Omnipaque® and Movprep®). Subjects will 
be included in the analysis according to the treatment actually 
received.  
Full analysis 
(FA) set: 
All correctly included and randomised subjects who received at least 
some portion of the contrast agents (Lumentin® 44, diluted 
Omnipaque® and Movprep®) and for whom a CT-scan has been 
performed. All subjects will be included in the group according to 
the intention based on the randomisation. 
Per protocol 
(PP) set: 
All subjects of the FA set who are compliant with the trial protocol, 
i.e., who do not experience any major protocol deviations. 
All efficacy analyses will be performed for both the FA set and the PP set. The analysis 
of the primary efficacy parameter based on the PP set will be regarded as the primary 
analysis. The analyses on the FA set will be considered as sensitivity analyses.  
 
All safety analyses will be based upon the Safety Set. 
13.2 General Considerations 
All statistical tests will be 2-sided and significance-values less than 5 % will be 
considered statistically significant even though adjustment for multiplicity will not be 
performed, unless otherwise stated. Confidence intervals will be two-sided at the 95% 
confidence level.  
Continuous data will be summarised using descriptive statistics (N, mean, median, 
standard deviation, minimum and maximum). Categorical data will be summarised by 
frequency tables (numbers and percentages).  
Unless otherwise stated, all analyses will be done on observed cases without any 
substitution of missing values.  
13.3 Demographics, Baseline Characteristics and Concomitant Medications 
Demographic data, baseline characteristics and concomitant medication will be 
summarised by means of descriptive statistics, stratified by treatment and randomisation 
stratification factors. Tables will be provided for the FA set and the PP set.  
Concomitant medication will be presented by ATC classification. 
13.4 Efficacy Analyses 
The primary efficacy objective will be analysed using data from patients in both the FA 
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13.4.1 Primary Efficacy Analysis 
There are two primary objectives 
• to compare the primary efficacy variable between patients randomised to Lumentin® 
44 and patients randomised to diluted Omnipaque® 
• to compare the primary efficacy variable between patients randomised to Lumentin® 
44 and patients randomised to Movprep 
The null-hypothesis that the primary efficacy variable is equal in the groups will be 
tested by means of the Wilcoxon rank sum test. In each of these analyses a two-sided p-
value less than 5 % is considered statistically significant. A successful result is that both 
these tests are statistically significant and hence there is no need for multiplicity 
adjustment. The randomisation is stratified by gender but the statistical analysis of the 
primary objective will not be stratified. 
13.4.2 Secondary Efficacy Analysis 
The secondary efficacy objectives will be analysed using the same principles and 
methods as the primary efficacy objectives. 
13.4.3 Drug Exposure 
Extent of exposure will be assessed using the amount contrast agent taken and body 
weight. The total exposure and exposure divided by the subject´s body mass index will 
be summarised by treatment group using descriptive statistics.  
13.4.4 Validity and repeatability of the primary endpoint 
The primary endpoint (i.e. the contrast) will be assessed by both the investigator and the 
sub-investigator, independently of each other. As an exploratory analysis, the 
relationship between the contrast measurements done by the investigator and the sub-
investigator will be analysed. The relationship will be investigated by calculating the 
Spearman rank correlation coefficient. As an analysis of a systematic difference between 
the operators the hypothesis that the contrast level is equal for the investigator and the 
sub-investigator will be tested using the Wilcoxon signed rank test. 
13.4.5 Adverse Events 
AEs will be coded using the latest available version of the MedDRA, the version of 
which will be provided in the clinical trial report.  
Pre-treatment AEs are AEs with onset prior to the intake of the contrast agent (Visit 1) 
that either stop prior to first administration of trial drug or are ongoing but do not 
deteriorate with respect to severity and/or relationship to trial drug after start of trial 
treatment. Pre-treatment AEs will be listed separately and will not be included in the AE 
tabulations. All other AEs will be considered as treatment-emergent AEs (TEAEs) and 
will be summarised per treatment group for the whole trial period. 
An overall summary table will be provided showing the number and percentage of 
subjects with any: 
• 
AE 
• 
TEAE 
• 
Severe TEAE 

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• 
Serious TEAE 
• 
AEs leading to withdrawal 
• 
Drug-related TEAE 
• 
Drug-related severe TEAE 
• 
Drug-related serious TEAE 
• 
TEAE leading to withdrawal 
• 
TEAE with outcome death 
The two-sided p-values of Fisher’s exact test for the 3 comparisons “Lumentin® 44 
versus diluted Omnipaque®”, “Lumentin® 44 versus p Movprep®” and “diluted 
Omnipaque® versus Movprep®” with regard to the percentages of subjects affected will 
be given in the overall summary table. The number of reported AEs will also be shown in 
this summary table. 
The above summary table may be repeated, stratified by randomisation stratification 
factors.  
13.5 Interim Analyses 
An interim analysis is not planned. 
13.6 Determination of Sample Size 
13.6.1 Sample size (per group) 
The standard deviation of the primary variable (i.e. the difference in contrast density in 
HU between bowel lumen and wall (mucosal lining), expressed as the mean of 9 
measurements performed in the 5 selected sub-segments of the small bowel) is estimated 
from the first pilot clinical study of abdominal CT examinations on healthy volunteers 
using a slightly different formulation (L60). Based on data from that study [1] it is 
assumed that the standard deviation will be around 2.00 and the difference between 
Lumentin® 44 and Omnipaque® as well as the difference between Lumentin® 44 
Movprep will be 1.50. Then 40 fully evaluable patients in the Lumentin group and 20 
patients in each of the comparator groups are needed to get 78 % power for each of the 
two primary objectives (no adjustment for multiplicity). This means that the total 
probability in the trial to get a p-value less than 5 % in the test of both the primary 
objectives is 0.78×0.78=0.61. 
13.6.2 Sample Size Formula 
The following formula has been used to calculate the number of patients needed [13] per 
group (Nper group): 
Nper group =
2 × 𝜎𝜎2 × ൫𝜆𝜆𝛼𝛼+ 𝜆𝜆𝛽𝛽൯
2
∆2
 
In the formula above σ is the standard deviation, ∆ is the difference to detect between the 
groups, λα is the 1−α percentile of the standardized normal distribution and λβ is the 1−β 
percentile of the standardized normal distribution. If the test is two-sided and the 

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significance level should be 0.0500 then λα = 1.9600. If the power is 80% then λβ = 
0.8416 and if the power is 90% then λβ = 1.2816. 
14 ETHICAL  
14.1 Independent Ethics Committee (IEC) 
The clinical trial must be approved by/receive favourable opinion from relevant 
Independent Ethics Committees (IECs) prior to enrolment of subjects. 
Any amendments to the approved clinical trial must likewise, as required, be approved 
by/receive favourable opinion from relevant IECs prior to implementation. 
The appropriate regulatory authority(ies) must be notified of/approve the clinical trial, as 
required. 
14.2 Ethical Conduct of the Trial 
This trial will be conducted to conform to the principles set out in the Declaration of 
Helsinki, revised 2013. 
This trial will be conducted in accordance with the principles of the Good Clinical 
Practice (GCP), relevant legislation including (Clinical Trial) Directive 2001/20/EC and 
guidelines of the ICH. 
This trial will be conducted in strict adherence to this protocol. If any changes to the 
protocol is required the protocol has to be amended, see section 16.2 Protocol 
Amendments.  
14.3 Subject Information and Consent 
All subjects will receive written and verbal information regarding the trial before any 
trial-related procedures are performed. This information will emphasise that participation 
in the trial is voluntary and that the subject may withdraw from the trial at any time and 
for any reason. All subjects will be given the opportunity to ask questions about the trial 
and will be given sufficient time to decide whether to participate in the trial. 
The patient’s signed and dated informed consent to participate in the trial will be 
obtained prior to any trial related procedure is being carried out. The consent form must 
also be signed by the person who conducted the informed consent discussion 
The consent includes information that data will be recorded, collected, processed and 
may be transferred to European Economic Area (EEA) or non-EEA countries. In 
accordance with the European Union (EU) Data Protection Directive (95/46/EC), the 
data will not identify any persons taking part in the trial. 
A copy of the subject information including the signed informed consent form will be 
provided to the subject, for their records. 
14.4 Subject Data Protection 
All information containing personal data will be handled in accordance with Swedish 
data protection legislation and with the EU Data Protection Directive (95/46/EC). 

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14.5 Other Ethical and Regulatory Issues 
If a significant safety issue is identified, either from an individual case report or review 
of aggregate data, then the Sponsor will issue prompt notification to all parties: 
Regulatory Authorities, Investigators and IECs. 
A significant safety issue is one that has a significant impact on the course of the clinical 
trial or program (including the potential for suspension of the trial program or 
amendments to protocols) or warrants immediate update of informed consent. 
 
14.6 Ethical Consideration statement 
The justification of this CT-trial is founded on the observation that the small bowel wall 
and its mucosal lining is so much better depicted on MRI images of the small bowel, 
especially on T1-weighted images after iv. Gadolinium, viz. with black bowel content 
and a contrast enhanced bowel wall. An equivalent image has hitherto not been possible 
to create with CT of the abdomen. As the availability world-wide of CT-equipment is 
plentiful and patient through-put is so much greater with CT than with MRI, most 
patients are referred for CT of the abdomen and for dedicated CT of the small 
bowel, even when a MRI-examination would be the preferred one, and in spite of the 
irradiation that comes with any CT-examination. Our newly invented per oral agent for 
bowel filling prior to CT of the abdomen has the potential to improve the CT-image of 
the bowel wall to the same quality as the T1 Gadolinium enhanced MRI image. This has 
been shown in a series of healthy, adult volunteers [1]. 
Allegedly benefits for future patients includes first and foremost CT-images easier to 
interpret, thereby facilitating diagnostics of early disease and reducing the risk of 
misreading’s. Secondly, risks of adverse effects are supposed to be reduced to a 
minimum as our new agent is food-based with 44% air in water, 2% egg white protein 
and less than 1% stabilizing components and taste improving additives  
No extra treatment to the patient having the new perusal agent is foreseen." 
15 DATA QUALITY ASSURANCE 
15.1 Quality Assurance 
The Sponsor or designee will conduct a site visit to verify the qualifications of the 
Investigator, inspect the site facilities, and inform the Investigator of responsibilities and 
the procedures for ensuring adequate and correct documentation. 
The Investigator is required to prepare and maintain adequate and accurate case histories 
designed to record all observations and other data pertinent to the trial for each trial 
participant. All information recorded on the eCRFs for this trial must be consistent with 
the subjects’ source documentation (i.e., medical records). 
Trial sites, facilities, laboratories and all data (including sources) and documentation 
must be available for GCP audit by Lument AB or inspection by competent authorities. 
Any aspect of the trial may be subject to audit by Lument AB and/or inspection by 
regulatory authorities or IEC. Such audits/inspections may take place at the sponsor’s 
site(s) or at any trial site including laboratories, pharmacies etc. 

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The monitor will, in case of audit, announce this in advance to the investigator and be 
present at the particular trial site during the audit. 
The site staff should assist in all aspects of audit/inspection. 
15.2 Trial Monitoring 
Lument AB, as sponsor of this clinical trial, is responsible to the regulatory authorities 
for assuring the proper conduct of the clinical trial with regard to protocol adherence and 
validity of the data recorded in the eCRFs. The company has therefore assigned persons 
to monitor this trial. Their duties are to serve as the principal link between investigators 
and Lument AB and advise the investigator on the collection and maintenance of 
accurate, complete, legible, well organised, and easily retrievable data for the trial. In 
addition, they will explain to the investigators any aspect of the (conduct of the) trial, 
including interpretation of the protocol, the purpose of collecting the specified data and 
reporting responsibilities. 
The monitor will visit the trial sites before, during and after the trial to ensure that the trial 
is conducted and documented in accordance with this protocol, ICH GCP guidelines, 
regulatory requirements and any trial specific documents such as eCRF completion 
guidelines. 
Monitoring visits will be conducted to confirm that e.g.: 
• The rights and well-being of human subjects are protected 
• The investigational team is adhering to the trial protocol 
• Informed consent has been obtained from all participants 
• AEs have been reported as required 
• Data are being accurately recorded in the eCRFs and are in accordance with source 
data 
• IP is being stored correctly and drug accountability is being performed on an on-
going basis 
• IP is given to correct subject 
• Facilities are, and remain, acceptable throughout the trial 
• The Investigator and the site are receiving sufficient information and support 
throughout the trial 
The eCRF data will be monitored on at regular intervals. The monitoring will include 
source data verification (SDV) according to the SDV list and verification of data 
consistency over time. The Investigator and other relevant trial personnel should be 
available during the monitoring visits. 
In order to perform their role effectively, monitors and persons involved in quality 
assurance and inspections (see above) will need direct access to primary subject data, 
e.g., medical records, laboratory reports, appointment books, etc. The review of medical 
records will be performed in a manner to ensure that subject confidentiality is 

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maintained. Because this affects the subject’s confidentiality, this fact is included on the 
Subject Information Sheet and Informed Consent Form. The Investigator assures the 
Sponsor of the necessary support at all times. 
This trial is organised by Lument AB and all enquiries should be made to a member of 
Lument AB staff (see Section 2, Company Personnel). 
15.3 Confidentiality 
All trial findings and documents will be regarded as confidential. The Investigator and 
members of his/her research team must not disclose such information without prior 
written approval from the Sponsor. 
The anonymity of participating subjects must be maintained. Subjects will be identified 
on CRFs by their subject number. On the SAE reports and all other source documents, 
the subject will be identified via subject number, second letters of the subject’s names 
and birth date. Documents not to be submitted to the Sponsor that identify the subject 
(e.g., the signed informed consent) must be maintained in confidence by the Investigator.  
15.4 Source Data 
Source data: All information in original records and certified copies of original records 
of clinical findings, observations, or other activities in a clinical trial necessary for the 
reconstruction and evaluation of the trial. Source data are contained in source 
documents (original records or certified copies). (ICH E6, 1.51). 
Source documents: Original documents, data, and records (e.g., hospital records, 
clinical and office charts, laboratory notes, memoranda, subjects diaries or evaluation 
checklists, pharmacy dispensing records, recorded data from automated instruments, 
copies or transcriptions certified after verification as being accurate copies, microfiches, 
photographic negatives, microfilm or magnetic media, x-rays, subject files, and records 
kept at the pharmacy, at the laboratories and at medico-technical departments involved 
in the clinical trial). (ICH E6, 1.52). 
Source Data Verification (SDV) is a key function in assuring the sponsor that clinical 
trial information is recorded and handled in a way that allows its accurate reporting, 
interpretation and verification. Monitors will, during the conduct of the clinical trial, 
perform SDV to confirm the accuracy and completeness of eCRFs by verifying data 
recorded in the eCRF against data recorded in source documents to ensure such records 
are consistent.  
To enable SDV it is essential, that what constitutes source data/documents (see definition 
above) for the trial data to be collected in the eCRF as well as where such data can be 
found at the trial site is established and agreed with the investigator at each trial site and 
documented, prior to initiation of the clinical trial.  
Source data cannot be entered directly into the eCRF. Source data should as a general 
rule be recorded in the subject’s medical record or other defined document normally used 
at the trial site. Source data may be entered on a worksheet only if the clinical trial 
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For this trial, since data are entered into eCRF, all parameters collected in the eCRF 
should be verifiable from source documents available on site. These parameters include, 
but are not limited to: 
 
• A statement that the subject is in a clinical trial 
• The identity of the trial e.g. Trial code 
• Subject screening number and/or subject number 
• date of conducting informed consent process 
• date of study visits and date leaving study 
• relevant medical history and diagnosis  
• data for evaluation of eligibility criteria 
• dispensation/administration of trial medication 
• concomitant medication (including changes) and diagnoses 
• subject demographics; sex and date of birth 
• laboratory data 
• adverse events, (nature, dates) 
• Date of trial termination 
 
The Investigator is responsible for ensuring the accuracy, completeness, legibility and 
timeliness of the data recorded in the eCRFs. Data reported in the eCRF that are derived 
from source documents should be consistent with the source documents or the 
discrepancies should be explained. Completed sections of eCRFs will be monitored on a 
regular basis. 
15.5 Case Report Forms (CRFs) 
Data collected in this trial will be by means of Remote Data Capture. The investigator or 
staff authorised by the investigator will enter patient data into electronic CRFs.  
 
A separate, numbered eCRF will be used for each patient enrolled. Data recorded in the 
eCRFs will be accessible to site staff through a secure internet connection immediately 
after entry. The eCRFs must be maintained in an up-to-date condition at all times by the 
investigator. The investigator, or sub-investigator(s) authorised by the investigator, will 
electronically sign all sections of eCRFs used. This signature information (incl. date of 
signature) will be kept in the audit trail and is unalterable. Only appropriately medically-
qualified (sub)investigators can sign data on clinical assessments/safety. Any 
correction(s) made by the investigator, or authorised site staff, to the eCRF after original 
entry will be documented in the audit trail. Changes to data already approved, requires 
the re-signature of investigator or authorised staff. The audit trail will identify the person 
making the change and the date, time and reason for the change.  
 
The trial monitor will check the eCRFs for accuracy and completion and perform source 
data verification. For archiving purposes, each investigator will be supplied with a copy 
of the eCRFs, for all patients enrolled at the site, via an electronic medium at completion 
of the trial. Audit trail information will be included. cCRFs will be available for 

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inspection by authorised representatives from Lument AB, from Regulatory Authorities 
and/or IEC. 
15.6 Data Management 
Patient data should be entered into the electronic eCRF by authorised site staff in a 
timely manner and not later than a week after the patients visits. Data will be entered by 
site staff and systematic data validation will be performed through the discrepancy 
management system within the data collection software. Queries for discrepant data may 
be generated automatically by the system upon entry or generated manually by the 
monitor or the study data manager. All queries, whether generated by the system or by a 
user, will be in an electronic format. This systematic validation will provide a clean and 
consistent database prior to the statistical analysis.  
Before database closure a reconciliation will be performed between the SAEs entered in 
the safety database and the trial database. 
Any deviations, i.e. discrepancies and additions from the process defined in the Data 
Management Plan, will be described in a trial specific Data Management Report. 
15.7 Archiving Trial Records 
According to International Conference on Harmonization (ICH) guidelines, essential 
documents should be retained for a minimum of 2 years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or at least 2 years have elapsed since the formal 
discontinuation of clinical development of the investigational product. However, these 
documents should be retained for a longer period if required by the applicable legal 
requirements. 
16 TRIAL MANAGEMENT  
16.1 Time Schedule 
Planned date of enrolment of first patient: November 2017. 
Planned date of enrolment of last patient: December 2018. 
Planned date of completion of last patient: December 2018. 
16.2 Protocol Amendments 
Neither the investigator(s) nor Lument AB will change the Clinical Study Protocol 
without written agreement between Lument AB and the Investigator. Any modification 
considered substantial requires approval/favourable opinion by the appropriate regulatory 
authority and IEC/IRB. 
Non-substantial changes (e.g. Changes not affecting the subject benefit/risk ratio) may be 
made without the need for a formal IEC/Competent Authority approval. All non-
substantial amendment will be logged on a non-substantial amendment list. All non-
substantial amendments will be distributed to all protocol recipients, with appropriate 
instructions. 

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Protocol amendments are issued as Consolidated Clinical Study Protocols comprising all 
current amendments. Consolidated Clinical Study Protocols become effective when 
written approval has been provided by the Investigator, the Sponsor, and 
approval/favorable opinion from regulatory authorities and/or IEC has been obtained, as 
required. 
16.3 Agreements 
Before the initiation of a clinical trial at a trial site, all financial arrangements with the 
investigator/institution and all other relevant parties (such as laboratories) must be 
confirmed in writing in formal agreement(s). 
16.4 Duration of the Trial 
The maximum duration of the trial for each subject will be up to 3 days (including 
telephone contact).  
The trial will be closed when all subjects have completed contact 2, telephone interview 
or resolution of ongoing AEs, whichever occurs last. 
16.5 Completion of Trial 
16.5.1 Trial Completion Procedures 
The end of trial is defined as the date of the last patient’s last visit. 
 
The Investigator will be informed when patient recruitment is to cease. 
 
Trial enrolment will be stopped when the total requested number of evaluable subjects 
for the trial has been obtained, or when a total of 88 subjects have been randomized, 
whichever comes first. 
 
Upon completion of the trial, Lument AB will undertake arrangements for collection and 
disposal any unused trial material that the investigator is not required to keep in his/her 
files. 
The trial may stop prematurely If the Investigator or the Sponsor becomes aware of 
conditions or events that suggest a possible hazard to subjects if the trial continues, the 
trial may be terminated after appropriate consultation between the relevant parties. The 
trial may also be terminated early at the Sponsor’s discretion in the absence of such a 
finding. 
Conditions that may warrant termination include, but are not limited to: 
• The discovery of an unexpected, significant, or unacceptable risk to the subjects 
enrolled in the trial, 
• Failure to enrol subjects at an acceptable rate, 
• A decision on the part of the Sponsor to suspend or discontinue development of the 
drug. 
 

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16.6 Liability and Insurance 
Lument AB will take out reasonable third-party liability insurance cover in accordance 
with all local legal requirements. The civil liability of the Investigator, the persons 
instructed by him and the hospital, practice or institute in which they are employed and 
the liability of the Sponsor with respect to financial loss due to personal injury and other 
damage that may arise as a result of the carrying out of this trial are governed by the 
applicable law. 
Lument AB will arrange for Liability Insurance if subjects should be injured due to the 
participation in the trial and provided that sponsor is legally liable for that. 
Excluded from the insurance cover are injuries to health and deteriorations of illnesses 
already in existence which would have occurred or continued to exist even if the subject 
had not taken part in the clinical trial. 
The insurance cover is jeopardised if the subject fails to report immediately to the 
Investigator or responsible physician any injury to health, which might have resulted 
from participation in the clinical trial, or if he/she undergoes any other medical treatment 
without their consent before the clinical trial has been completely finished insofar as the 
individual subject is concerned. 
Any injury to health, which might have occurred as a result of participation in the clinical 
trial, must be reported by the subject to the Investigator without delay. The Investigator is 
obliged to make such a report in any case. 
16.7 Use of information 
All unpublished information relating to this clinical trial and/or to the investigational 
product(s), is considered confidential by Lument AB and shall remain the sole property 
of Lument AB. The investigator should understand and agree that Lument AB may use 
the information from this clinical trial in connection with the development of the product, 
and therefore, may disclose it as required to other investigators, to regulatory authorities 
and commercial partners. 
16.8 Publication Policy 
By signing the trial protocol, the Investigator agrees with the use of results of the trial for 
the purposes of national and international registration, publication and information for 
medical and pharmaceutical professionals. If necessary, the authorities will be notified of 
the Investigator's name, address, qualifications and extent of involvement. 
An integrated clinical trial report will be prepared by the Sponsor and reviewed by 
Investigator. A summary of the clinical trial report (according to CPMP/ICH137/95) 
should be sent to the Regulatory Authorities and IEC according to the relevant 
guidelines. 
No data from the clinical trial may be published, presented or communicated, except to 
regulatory authorities, prior to the release of the internal clinical trial report, unless 
approved by the Sponsor in writing. 
The Sponsor and/or the investigators are obliged to publish the results of the trial. A 
publication will be prepared in a peer-reviewed indexed journal irrespective of the 

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outcome. Considerations should be made regarding potential patents or other clinical trial 
data. Should a publication not be available within 200 days from the end of the analysis, 
the investigators are free to prepare such a publication on condition of notifying the 
Sponsor and giving the Sponsor 60 days to comment any manuscript. 
In the event of a publication, the names of the authors and their order of appearance will 
be as follows: The Investigator, the Sub-investigator, and representatives of Lument AB. 
 
 
 
 

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17 REFERENCE LIST 
1. Fork T, Adnerhill I, Böök O, Casal-Dujat L, Leander, P, Stathis, G, Öste R. A novel food based oral 
contrast agent with negative Hounsfield units for demarcation of small bowel loops on 
abdominal CT. (In manuscript) 
2. Masselli G, Gualdi G: MR imaging of the small bowel. Radiology 2012; 264(2): 333-48 
3. Peter W. Field: “Negative contrast agent” CA1116084 (1982)  
             
4. Hasegawa Hideo et al.: X-ray contrast composition for digestive tract JPH06228013 (1994)       
5. Unger Evan C. “Stabilized homogeneous suspensions as computed tomography contrast agents” 
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Appendix 2 
 
 

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Appendix 3 
 

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