EXPLORER PET/CT: A Pilot Evaluation in Healthy Volunteers
Phase: NA
Conditions: Healthy
Sponsor: University of California, Davis

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1) Protocol Title 
Title:  EXPLORER PET/CT: A Pilot Evaluation in Healthy Volunteers 
Principal Investigator: Lorenzo Nardo, MD, PhD, Assistant Professor of Radiology 
Protocol Version Date: January 27, 2021  
 
2) Objectives 
The objective of this pilot study is to collect preliminary data using total body 
scans on a new, first of its kind, FDA 510k-cleared positron emission 
tomography/computed tomography (PET/CT) scanner, called EXPLORER. Built 
by United Imaging Healthcare (UIH)1 in collaboration with investigators at UC 
Davis, EXPLORER has the potential to significantly alter the practice of PET/CT2,3. 
This initial pilot study will have the following broad objectives:       
Objective 1: To obtain preliminary data on (a) delayed, (b) low-dose and (c) 
total body dynamic acquisitions on the EXPLORER PET/CT scanner. 
Objective 2: (d) To obtain preliminary data regarding possible impacts on 
18F fluorodeoxyglucose (FDG) PET image quantification related to use of 
intravenous iodinated contrast agent with the EXPLORER PET/CT 
scanner. 
3) Background 
The 194 cm long EXPLORER total-body PET scanner is the world’s first 
device to offer the ability to tomographically image all parts of the body 
simultaneously. It has the potential for a signal sensitivity gain of ~40-fold 
compared to existing commercially available devices for total-body applications. 
Spatial resolution is also comparable to or better than all other commercially 
available clinical devices available today.2-4 Answering the basic questions that this 
new equipment poses constitutes an important advancement for both clinical and 
academic settings. 
(A) The distribution of radiotracer activity depends on post-injection imaging time 
for both anatomical structure and pathologic processes. Different anatomic 
structures and different pathologic abnormalities are characterized by different time-
activity curves.5 However, delayed imaging results in lower signal due to 
radioactive decay and physiological washout, which has so far limited the 
evaluation of late time-to-activity curves due to the low sensitivity of conventional 
scanners6. The increased sensitivity of EXPLORER has the potential to overcome 
this limitation and allow for high-quality delayed scans.7 We seek to obtain 
preliminary data regarding the time-course of the most commonly-used PET 
radiotracer 18F fluorodeoxyglucose (FDG) concentration in tissues over a twelve-
hour period.    In addition, for precise characterization of FDG clearance through 
the urinary system we will assess radiotracer activity in urine collected from 

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subjects.  Assessment of excreted FDG will increase the precision of estimated SUV 
values.   For analysis of small structures in the brain, we will use MRI to guide 
region of interest placement - this has been standard practice in multiple studies for 
the last 25 years8. 
(B) EXPLORER PET/CT allows for the possibility of very low-dose imaging. 7 This 
is clinically important for pediatric patients who may have multiple scans and are 
more impacted by the stochastic effects of radiation than the adult population.9 It is 
also important for research, where the subjects receive no benefit from the radiation 
exposure associated with the scan. However, we do not have information on the 
statistical quality of low-dose scans with EXPLORER and this information is 
essential for power calculations for future studies. 
(C) EXPLORER  whole body PET/CT  is the only scanner in the world capable of 
acquiring total body dynamic images. Acquisition of dynamic images will allow 
new applications such as organ perfusion imaging.7 Available PET/CT scanners can 
obtain perfusion images only on a portion of the body as large as their axial field of 
view, generally anywhere between 15-30 cm. EXPLORER can cover the total body 
and provide useful perfusion data in addition to early FDG biodistribution data and 
other functional parameters. We seek to obtain preliminary data regarding perfusion 
and early biodistribution images; this will be vitally important for the design of 
future studies. 
(D) Intravenous iodinated contrast is commonly used in routine CT to increase the 
visualization of both anatomic and pathologic processes. Physically, the presence of 
iodine atoms increases  the attenuation coefficient for CT radiation of the tissues in 
which it distributes by increasing the cross-section for photoelectric interactions. 
Applying attenuation correction algorithms for PET using contrast CT images has 
the potential to overcorrect the PET emission signal (which is much less susceptible 
to photoelectric interactions), introducing possibly significant errors in the final 
uptake quantification. While several studies have demonstrated that there is no 
statistically significant increase in uptake values upon injection of iodinated contrast 
when normal anatomic structures are assessed, at the present time, there is no study 
validating the use of contrast enhanced CT for attenuation correction purposes on 
the EXPLORER PET/CT scanner. We seek to obtain preliminary data to understand 
the impact of intravenous iodinated contrast agent on quantification of PET images. 
 
 
REFERENCES 
1. 
U.S. Food & Drug Adminstration. uMI 780 PET/CT System. 2018, April 13; 
https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172143.pdf. Accessed 
October 2, 2018, 2018. 

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2. 
Cherry SR, Badawi RD, Karp JS, Moses WW, Price P, Jones T. Total-body 
imaging: Transforming the role of positron emission tomography. Sci Transl Med. 
2017;9(381). 
3. 
Badawi R, Liu W, Berg E, et al. Progress on the EXPLORER project: towards a 
total body PET scanner for human imaging. Journal of Nuclear Medicine. 
2018;59(supplement 1):223-223. 
4. 
Zhang X, Badawi RD, Cherry SR, Qi J. Theoretical study of the benefit of long 
axial field-of-view PET on region of interest quantification. Phys Med Biol. 
2018;63(13):135010. 
5. 
Lodge MA, Lucas JD, Marsden PK, Cronin BF, O'Doherty MJ, Smith MA. A 
PET study of 18FDG uptake in soft tissue masses. Eur J Nucl Med. 
1999;26(1):22-30. 
6. 
Chen YM, Huang G, Sun XG, et al. Optimizing delayed scan time for FDG PET: 
comparison of the early and late delayed scan. Nucl Med Commun. 
2008;29(5):425-430. 
7. 
Badawi RD, Shi H, Hu P, et al. First Human Imaging Studies with the Explorer 
Total-Body Pet Scanner. J Nucl Med. 2019. 
8. 
Aiello M, Salvatore E, Cachia A, et al. Relationship between simultaneously 
acquired resting-state regional cerebral glucose metabolism and functional MRI: a 
PET/MR hybrid scanner study. Neuroimage. 2015;113:111-121. 
9. 
Fahey FH, Goodkind A, MacDougall RD, et al. Operational and Dosimetric 
Aspects of Pediatric PET/CT. J Nucl Med. 2017;58(9):1360-1366. 
10. 
ACR Committee on Drugs and Contrast Media. ACR Manual on contrast media 
version 10.3. 2018; https://www.acr.org/-/media/ACR/Files/Clinical-
Resources/Contrast_Media.pdf. Accessed 07/26/2019, 2019. 
 

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4) Inclusion and Exclusion Criteria 
Inclusion criteria: 
• Men and women, 18 years of age or older 
• Willing and able to fast for at least 6 hours before and for the duration of 
the scan 
• Willing to provide urine sample throughout scan visit 
• Willing and able to lay motionless in a supine position for 60 and 20 
minutes at separate timepoints. 
• Willing and able to give informed consent, personal contact information 
(phone number, email and postal address), insurance information, and 
primary care physician contact. 
 
Exclusion criteria: 
• No Primary Care Physician 
• No health insurance 
• Body weight more than 240 kg (529 pounds) 
• Allergy to iodine contrast (only for subjects enrolled in Arm 3) 
• Creatinine levels > 1.5 mg/dL or estimated glomerular filtration rate 
(eGFR) < 60 ml/minute (only for subjects enrolled in Arm 3) 
• Recent (within 90 days) contrast enhanced CT (only for subjects enrolled 
in Arm 3) 
• Any known concomitant acute infection (including upper respiratory 
infection, genitourinary infections, etc.  
• History of metastatic or newly (last 5 years) diagnosed locally invasive 
cancer. 
• Chemotherapy in the last 5 years 
• Radiation therapy in the last 3 years 
• Major surgery within the last 6 months. 
• Pregnancy or breast-feeding 
• Diabetes 
• Fasting blood glucose level > 160 mg/dL before administration of FDG 
• Prisoners  
• The standard MRI contraindications will be applied, according to UC Davis 
Department of Radiology Magnetic Resonance Safety Policy ID 1727, 
which may include:  
o Having a pacemaker or other implanted electronic device, 
o Metal foreign bodies, aneurysm clips, heart valve prosthesis, 
vascular stents, cochlear implants, embolization coils, gunshot 
wounds with retained bullet fragments, certain types of penile 
implants, and certain types of intrauterine devices (IUDs). 
o Claustrophobia 

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5) Study Timelines 
• Subject participation: Each subject will participate in a single arm 
of this three-arm study (please see below), for up to approximately 
13 hours during a single study visit (Study Arm 1), 4 hours for 
Study Arm 2 and 2 hours for Study Arm 3.   
• Enrollment duration: We anticipate completing enrollment within 
8 months. 
• Primary data analysis duration: We anticipate completing primary 
data analysis within 12 months. 
6) Study Endpoints: all study endpoints are exploratory 
 
A. To collect preliminary data regarding FDG biodistribution as a function 
of time 
Population: Study Arm 1 
Explanation: Changes are measured quantitatively from time-activity curves 
(TACs) generated for different organs using regions of interest (ROIs).  
 
B. To obtain preliminary data regarding low dose EXPLORER protocols 
Population: Study Arm 2 
Explanation: Regions of interest (ROI) will be placed in several organs; pixel 
intensity and coefficient of variation within ROI will be recorded.  
 
C. To collect preliminary data about total body FDG perfusion and early 
biodistribution . 
Population: Study Arms 1-3 
Explanation: Total body EXPLORER PET images will be obtained for the 
first 60 minutes following injection. Organ perfusion and early FDG 
biodistribution will be evaluated with time-activity curves and mathematical 
analysis generated for different organs using regions of interest (ROIs). 
 
D. To obtain preliminary data to understand whether intravenous iodinated 
contrast agent produce a significant change in quantification of FDG 
uptake levels. 
Population: Study Arm 3 
Explanation: Regions of interest will be placed in several organs; pixel 
intensities within ROI will be recorded. Data reconstructed using contrast-

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enhanced CT for attenuation correction will be compared to data 
reconstructed using non-contrast enhanced CT for attenuation correction. 
 
7) Procedures Involved 
Subject recruitment: 
Up to 15 subjects per arm (please see below) will be recruited by means of a 
flyer posted in specific areas: the Division of Nuclear Medicine (Davis Tower, 
Ambulatory Care Center (ACC)), the UC Davis Explorer Molecular Imaging Center 
located at 3195 Folsom Blvd, Sacramento, CA, the research laboratories of Dr. John 
Boone and Dr. Ramsey Badawi (ACC Suite 0505), the Radiology Academic office 
(ACC, Suite 3100), and the research laboratories of Dr. Simon Cherry and Dr. Jinyi 
Qi (Main campus, GBSF). In addition, flyers will be posted in other academic 
offices at ACC including cardiology, ophthalmology, orthopedics, etc. 
Additionally, the study will be announced on the EXPLORER website: 
https://explorer.ucdavis.edu/  
Study procedures: 
At the time of the consenting and screening visit, a study-specific 
Inclusion/Exclusion source document will be used to determinate eligibility for this 
study after obtaining informed consent. The consenting and screening visit will 
occur at either the ACC Building Suite 3100, in the Main Hospital Nuclear Medicine 
Department or at EXPLORER Molecular Imaging Center (3195 Folsom Boulevard, 
Sacramento) not earlier than 4 weeks before the imaging visit. Study participants 
will be screened for eligibility at the time of the consenting and screening visit after 
signing the consent form. The subject can be enrolled in only one Arm; the 
participant can choose which Arm of the study he or she wants to be enrolled in 
until the recruitment for the specific Arm is completed. For participants enrolled in 
Arm 3, if recent (within 1 month)10 serum creatinine and/or GFR results are not 
available, an order will be placed for participants to go to a UC Davis Health lab for 
this testing, at no charge to them prior to the imaging visit. For the subject for whom 
the screening requires renal function tests, the doctor will receive notification of test 
results through the EMR system directly from the UC Davis Health lab. The doctor 
will review the results (in the subjects to whom any of these tests apply) and will 
report on the screening form the results and will state eligibility of the subject for 
the study. 
Participants will be asked to fast for 6 hours prior to arriving at the 
EXPLORER Molecular Imaging Center (3195 Folsom Blvd, Sacramento) on the 
day of their PET imaging study visit. A technologist will screen the participants  to 
evaluate their readiness for PET scanning using the standard UC Davis Radiology 
approved form. A urine pregnancy test will be administered to all women of child-
bearing potential, at no charge. Blood glucose level will be tested using the standard 

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fingerstick method by standard operating procedures, at no charge. Following this, 
an intravenous (IV) line will be placed in the forearm by the study PET/CT 
technologist or study physician and the participant will be positioned supine on the 
scanner table.  From the time of injection with FDG we will collect urine from all 
subjects until the scan visit at EXPLORER is complete.  Subjects will be asked to 
urinate into a portable unisex urinal.  After the total amount of excreted FDG is 
assessed and recorded, we will dispose of the urine sample. We will also ask all 
subjects if they had a bowel movement from the time they are injected with FDG 
until they complete their scan(s). 
Arm 1 (N=15; delayed imaging acquisition): 
For Study Arm 1, 10 +/-2 mCi of 18F fluorodeoxyglucose (FDG) will be hand 
injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. 
The IV line will be removed after dynamic acquisition. The dynamic scan will be 
preceded by ultra low-dose (estimated dose of 1.298 mSv) CT scan. This CT scan 
will provide information for attenuation correction for the PET data. At 90 minutes, 
3-, 6-, 9- and 12-hours, a static whole-body scan for 20 minutes will be acquired on 
EXPLORER. Prior to the 90-minute scan a low-dose CT (estimated dose of 7.44 
mSv) will be obtained both for anatomic localization and for attenuation correction 
purposes. Prior to each of the later time-points (3-, 6-, 9- and 12-hours), an ultra 
low-dose (estimated dose of 1.298 mSv) CT scan will be acquired. This scan will 
be for attenuation correction purposes only. Following the 12-hour scan, the 
participant’s study visit will be completed. Participants will be monitored for 
adverse reactions related to prolonged fasting (e.g. hypoglycemia) between 
scanning sessions. In addition, low carbohydrate snacks will be available following 
the 3-hour scan. 
 
Arm 2 (N=15; low FDG dose imaging):  
For Study Arm 2, 0.5 +/- 0.1 mCi of 18F-FDG (1/20th of the standard dose) 
will be hand injected through the IV and a 60-minute dynamic scan will begin on 
EXPLORER. The dynamic scan will be preceded by an ultra-low-dose CT scan  
(estimated dose of 1.298 mSv) for attenuation correction. The standard 20-minute 
EXPLORER scan obtained at 90 minutes will be obtained after a low dose CT 
(estimated dose of 7.44 mSv) for attenuation and co-localization. The standard 20-

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minute EXPLORER scan obtained at 3 hours will be preceded by an ultra-low-dose 
CT scan (estimated dose of 1.298 mSv) for attenuation correction only. 
 
Arm 3 (N=15; comparison PET images reconstructed using CT-based 
attenuation correction acquired with and without iodinated contrast enhancement):  
For Study Arm 3, 10 +/-2 mCi of 18F-FDG will be hand injected through the 
IV and a 60-minute dynamic scan will begin on EXPLORER. Prior to the dynamic 
scan, an ultra-low-dose CT scan (estimated dose of 1.298 mSv) will be acquired for 
attenuation correction purposes only. At 90 mins, a low dose non contrast 
enhancement CT (estimated dose of 7.44 mSv) will be acquired vertex to toes.  
Iodinated contrast (150 cc of iodine Omnipaque 350) will then be intravenously 
injected (through the same IV placed to inject FDG) at 3 ml/sec while the patient 
remains still on the scanner and a second low-dose CT will be acquired. Finally, a 
20-minute PET acquisition will be performed. The IV line will be removed after 
completion of the study.  
Patients on all arms 
All patients will undergo a brain MRI scan (without contrast), within  90 days 
of the PET/CT visits. The rationale for the MRI study is to provide a detailed 
anatomical map, which is not obtainable by CT.8 MRI will be acquired using head 
coil on one of the clinical FDA-approved MRI scanners at UC Davis Medical 
Center. Several gradient echo, spin echo and fast spin echo sequences will be 
obtained.  
The PET/CT images created for this study are for research and are not meant to 
evaluate subject health, as they would be if they were part of a clinical (non-
research) visit to the doctor or hospital. The images will not receive any routine 
clinical review by radiologists who interpret PET/CT scans. This means that some 
findings may be overlooked or misinterpreted.  However, if the PET/CT 
technologists do notice findings that cause concern, they will notify the Study 
Radiologist.   Additionally, if a member of the research team notices any findings 
that cause concern while conducting image review for study purposes, they will 
notify the Study Radiologist. The Study Radiologist will conduct a brief review of 
part of the study images for quality purposes.   If the Study Radiologist thinks a 
clinical problem is present, one of the IRB-approved study physicians will discuss 
these possible problems with the subject within 8 weeks or immediately upon 
recognition of any critical finding that requires immediate and/or urgent 
intervention as described in the Department of Radiology Critical Findings policy 
(full dataset of images are sometimes not available for review in less than 3 days).  
Upon written request, we will provide the subject with a copy of a subset of their 
CT images to take to the physician of their choosing. A subset of PET images may 
also be shared with the subject unless the images from the study are clinically 

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uninterpretable. In addition, the sponsor may restrict sharing of PET images due to 
the nature of the research protocol or to protect intellectual property (e.g. 
proprietary radiotracers). We will send a standard letter to the designated licensed 
medical provider identified by the subject along with a copy of the subject’s 
radiology report.  The standard letter will state that (i) the subject’s images were 
acquired exclusively for a research study and incidental findings that may be 
related to a medical condition were observed by a UC Davis radiologist; (ii) the 
images did not receive any dedicated routine clinical review and findings may 
have been overlooked or misinterpreted; (iii) the subject’s physician can contact 
the study doctor at any time if there are any concerns regarding the study or the 
subject’s findings. In addition, Dr. Lorenzo Nardo or a designee will contact the 
research subjects and ask what type of medical follow-up, if any, they received. 
They will also ask questions related to subject’s history of cancer, history of respiratory 
disease, and cigarette smoking history. 
 
If there are findings on any of the scans that can deem the subject as not meeting 
the inclusion/exclusion criteria (e.g. metastatic disease, marked claustrophobia 
leading to incomplete scans. etc), this event will be reported and the subject will 
be excluded from the study. An additional participant will be added to meet the 
recruitment target of that specific arm. 
   
 
Participants will be compensated with gift cards at a rate of $25 (upon enrollment 
and radiotracer injection), plus an additional $25 for each hour of participation as 
follows: 
• 
Arm 1:  up to 13 hours + Brain MRI scan: 1 hour ($25); total of $375 
• 
Arm 2: up to 4 hours + Brain MRI scan: 1 hour ($25); total of $150 
• 
Arm 3: up to 2 hours + Brain MRI scan: 1 hour ($25) + $50 for 
creatinine testing; total of $150 
 
There is no compensation associated with initial consenting and screening visit 
and also with the optional visit(s) intended to discuss scan findings with study 
doctors. 
 
 
 
 
 
 
 
 
 
 

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Study Schema: 
 
   
Data analysis plan: 
Image reconstruction and analysis: Data from EXPLORER (all the three study 
arms) will be acquired in listmode. Data will be reconstructed using manufacturer’s 
recommendations. Image quality, quantitative comparisons and preliminary 
biodistribution data collection will be performed by means of regions of interest 
(ROIs) drawn in different organs and tissue types where pixel intensity and 
coefficient of variation within ROIs will be computed and recorded.  
Statistical considerations: 
Since this is a pilot exploratory study on a first-of-its kind scanner, no formal power 
analysis is presented.  
Exploratory data analysis will be conducted to examine the distribution of the data. 
Graphical methods including box-plots and histograms will be employed to 
examine the distributions of the measures. For all continuous variables, descriptive 
statistics, including means, ranges, and standard deviations will be computed. 
Ninety-five percent confidence intervals will be computed for means and 
proportions to obtain interval estimates of all measurements across image. For 
categorical data, frequency, proportions, and percentages will be calculated. 
8) Data and/or Specimen Management and Confidentiality 
At the time of data acquisition, identifiable information will be entered in the 
UC Davis system database. Electronic image files, radiation dose reports and 
pertinent medical information will be stored on the EXPLORER research cluster at 

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3195 Folsom Blvd (UC Davis facility), on dedicated encrypted password-protected 
hard disks and workstations at UC Davis, which project staff may access; in 
addition, electronic image files, radiation dose reports and pertinent medical 
information will be stored on the UC Davis radiology department PACS system, 
Radimetrics dose reporting system and Electronic Medical Record. These files will 
contain the patient identifiers. When this data is transferred for analysis to any other 
computer/device, it will be anonymized. We will assign participants a unique 
subject/code number that will be used to identify them in our database. Our data will 
be in the form of anonymized images and coded medical records reported in an 
Excel spreadsheet and images in electronic format. The Excel spreadsheet and the 
images containing the subjects coded medical records will be stored in a encrypted 
password-protected device. We will keep the code key containing subject 
names/medical record numbers and corresponding subject code numbers in a 
secured location separate from the data. Only study team will have access to the 
data. Requests to use the data will be reviewed by the PI, if approved, PI will provide 
only de-identified data. Quality control will include regular data verification and 
protocol compliance checks by the PI and the study coordinator. The PI will 
complete annual reports to the UC Davis IRB detailing the study progress and 
enrollment status.  
9)  Data and/or Specimen Banking 
All the imaging data will be banked indefinitely for future use. Data will be 
saved on the EXPLORER research cluster at 3195 Folsom Boulevard and/or on 
dedicated encrypted password-protected hard disks and workstations at UC Davis 
with access limited to authorized personnel. in addition, electronic image files, 
radiation dose reports and pertinent medical information will be stored on the UC 
Davis radiology department PACS system and Electronic Medical Record. A 
radiation dose report will be generated. This will be part of the banked data and will 
contain Protected Health Information. It will be sent to Radimetrics system, which 
is a mandated tracking system for lifetime radiation dose. 
Future use of banked data may include improved image analysis, use as a 
normal atlas/comparator, and use for other research purposes.  
In addition, investigators from other entities may contact the study team with 
requests to use banked data. Anonymous data may be shared with other entities if 
appropriate data use agreements are in place (e.g., DTA and UC reliance) and if 
approved by the investigators in charge of this study. 
Biological specimens (blood sample) are used only for screening purposes. 
Urine samples will be used for screening purposes and to assess radiotracer activity 

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during scanning.  After the results are recorded the biological specimens will be 
discarded. 
10) Provisions to Monitor the Data to Ensure the Safety of Subjects 
Throughout the study, study personnel will consult with the UC Davis Health 
Radiation Safety Officer and the local IRB regarding the monitoring and reporting 
of adverse events and follow their recommendations. Protocol changes involving 
the radiation dose will first receive approvals from Radiation Use Committee prior 
to submitting a modification request to the IRB. 
Participants will be informed about the study risks including risks related to 
iodine contrast media administration (Arm 3 only) during the initial consenting and 
screening visit. In case a contrast reaction occurs, it will be handled per departmental 
standard operating procedure.  
 Protocol changes will not be implemented prior to UC Davis IRB approval 
unless necessary to eliminate apparent immediate hazards to the research subjects.  
If any incidental finding will be detected, they will be managed as described 
above in section “Procedures Involved” of this protocol. 
Data safety monitoring 
After acquisition of data, we will assign participants a unique subject/code 
number that we will use to identify them in the database used for processing, 
analysis, or publications. Our coded data will be in the form of elements of medical 
records recorded in an Excel spreadsheet saved in a encrypted password-protected 
device. Electronic image files, which may contain PHI, will be stored on the 
EXPLORER research cluster at 3195 Folsom Boulevard and/or on dedicated 
encrypted password-protected hard disks and workstations at UC Davis. In addition, 
electronic image files, radiation dose reports and pertinent medical information will 
be stored on the UC Davis radiology department PACS system the Radimetrics dose 
reporting system and the Electronic Medical Record. Quality control will include 
regular data verification and protocol compliance checks by the PI and the study 
coordinator. The PI will submit annual reports to the UC Davis IRB detailing the 
study progress and enrollment status. 
 
Breach of confidentiality 
Confidentiality will be protected through periodic assessment, as new study 
materials and communication methods among project staff develop. The PI will 

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report any confidentiality breaches to the IRB using the standard Reportable New 
Information form. 
11) Withdrawal of Subjects 
Subjects will be withdrawn from the study without their consent if: 
• they do not follow the study rules or they no longer meet the requirements to be in 
the study; or 
• the study is stopped by the sponsor or researchers. 
• the investigators feel it is in the participants best interest to discontinue 
participation. Such circumstances may include unanticipated discomfort and/or 
fatigue from laying on the scanner table, and feelings of claustrophobia from being 
inside the scanner bore. 
 
12) Risks to Subjects 
 
Risks to subjects may include: 
• Discomfort and/or fatigue from laying on the scanner table 
• Claustrophobic symptoms 
• Bruising and/or infection at the IV site 
• Radiation Risks:  This study involves a radiation exposure that is typical 
of other diagnostic tests using ionizing radiation. The amount of radiation 
exposure received in this study is below the levels that are thought to 
result in a significant risk of harmful effects. 
• It is possible that EXPLORER PET/CT may detect false positive findings 
that may require further follow-up (clinical, imaging or surgical) with all 
the risks associated with these follow-up procedures. These risks range 
from minor risks to severe risks including death and permanent 
diasabilities. 
• Hypoglycemia from prolonged fasting. 
Iodine contrast administration related risks (only for Arm 3):  
 
Minor/Common risks: 
• Bruising and/or infection at IV site 
• Nausea & vomiting 
• Urticaria (hives) 
• Pruritis (itching) 
• Diaphoresis (sweating) 
 
Moderate/Uncommon risks 
• Faintness 
• Facial edema (swelling) 

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• Laryngeal edema (swelling of the airway in the throat) 
• Bronchospasm (tightening of the airways in the chest) 
 
Severe/Rare risks 
• Pulmonary edema (fluid in the lungs) 
• Respiratory arrest (loss of breathing) 
• Cardiac arrest (loss of heartbeat) 
• Seizures 
• Death or permanent disabilities 
 
 
13) Potential Benefits to Subjects 
In general, we expect there to be no benefit to the subject If any incidental 
finding will be detected, they will be managed as described above in section 
“Procedures Involved” of this protocol.  
14) Multi-Site Research 
This study does not involve multiple sites. Please note that EXPLORER 
Molecular Imaging Center at 3195 Folsom Blvd, Sacramento, CA is a UC 
Davis facility which is entirely administrated by UC Davis employees. 
15) Community-Based Participatory Research 
This study does not involve community-based participatory research. 
16) Sharing of Results with Subjects 
The results of this research will not be shared with subjects. However, if any 
incidental finding will be detected, they will be managed as described above in 
section “Procedures Involved” of this protocol. 
 
17) Prior Approvals 
This study has been approved by the UC Davis Health Radiation Use 
Committee. 
18) Provisions to Protect the Privacy Interests of Subjects 
The investigator obtaining consent will meet with the candidate in a private setting 
and will dedicate sufficient time to explain the study procedures and answer any 
questions. It will be explained that participation is strictly voluntary and declining 
to participate will not affect them in any way. A HIPAA disclosure form will be 
signed by the subject to allow access to their medical records. 
19) Compensation for Research-Related Injury 
If a subject is injured as a result of being in this study, the University of California 
will provide the necessary medical treatment. Depending on the circumstances, the 
costs of the treatment may be covered by the University or the study sponsor or 
may be billed to the subject’s insurance company just like other medical costs. The 

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University and the study sponsor do not normally provide any other form of 
compensation for injury. For more information about compensation, the subject 
may contact the IRB Administration at (916) 703-9151 or  HS-
IRBAdmin@ucdavis.edu 
20) Economic Burden to Subjects 
Subjects will not be charged for their participation. In case of abnormal or unclear 
findings, the subject may decide in agreement with his/her Primary Care Physician 
to further investigate and the cost of this will be borne by the subject and/or his/her 
insurance.  
21) Drugs or Devices 
No investigational drugs or devices are involved. 
☐ I confirm that all investigational drugs will be received by the Investigational 
Drug Service (IDS).  The IDS will store, handle, and administer those drugs so 
that they will be used only on subjects and be used only by authorized 
investigators. 
 
☐ I confirm that all investigational devices will be labelled in accordance with 
FDA regulations and stored and dispensed in such a manner that they will be 
used only on subjects and be used only by authorized investigators. 
 
22) Review Requirements 
        Are there any contractual obligations or other considerations that 
require IRB review of this research, or review at intervals other 
than those required by the Common Rule or FDA? If yes, check 
box: 
 
 Yes 
 
☒ No