18F-DCFPyL PET/CT in Hepatocellular Carcinoma
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Sponsor: National Cancer Institute (NCI)

Abbreviated Title: 18F-DCFPyL in HCC
Version Date: 12/01/2023
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Abbreviated Title: 18F-DCFPyL in HCC
NIH Protocol #: 000080
NIH Addendum Version Date: 12/01/2023
NCT Number: NCT05009979
NIH ADDENDUM
Title: 18F-DCFPyL PET/CT in Hepatocellular Carcinoma
NCI Principal Investigator:
Freddy E. Escorcia, MD, PhD
Molecular Imaging Branch
National Cancer Institute
Building 10, Rm 1B55
9000 Rockville Pike
Bethesda, MD 20892
Phone: 240-858-3062
E-mail: freddy.escorcia@nih.gov
Drug Name:
18F-DCFPyL
18F-FDG
IND Number:
133631
133631
Sponsor:
NCI CCR
NCI CCR
Manufacturer:
PET department, NIH
Commercial
Supplier:
PET department, NIH
MIB
Coordinating Center: NCI, CCR

Abbreviated Title: 18F-DCFPyL in HCC
Version Date: 12/01/2023
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TABLE OF CONTENTS 
TABLE OF CONTENTS ................................................................................................................2
1
NUMBER OF PARTICIPANTS TO BE SEEN AT NIH.......................................................3
2
NIH REGISTRATION INFORMATION ...............................................................................3
2.1
Participant Registration and Status Update Procedures....................................................3
2.2
Cost and Compensation ....................................................................................................3
2.2.1
Costs ..........................................................................................................................3
2.2.2
Compensation ............................................................................................................3
2.2.3
Reimbursement..........................................................................................................3
3
CORRELATIVE STUDIES FOR RESEARCH .....................................................................3
3.1
Sample Storage, Tracking and Disposition.......................................................................3
3.1.1
Laboratory of Pathology............................................................................................3
3.1.2
Dr. Wang Laboratory.................................................................................................4
3.1.3
Dr. Jennifer Jones Laboratory....................................................................................4
3.1.4
Blood Processing Core (Laboratory of Dr. William Figg)........................................4
3.1.5
CCR Sequencing Facility ..........................................................................................5
4
NCI CLINICAL DIRECTOR REPORTING ..........................................................................6
5
CONSENT DOCUMENTATION WHEN ELECTRONIC CONSENT DOCUMENT USED 
AT NIH............................................................................................................................................6

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1
NUMBER OF PARTICIPANTS TO BE SEEN AT NIH
All 50 participants will be enrolled at the NIH. Some participants may have biopsies performed 
at the participating site.
2
NIH REGISTRATION INFORMATION
2.1
PARTICIPANT REGISTRATION AND STATUS UPDATE PROCEDURES
Registration and status updates (e.g., when a participant is taken off protocol therapy and when a 
participant is taken off-study) will take place per CCR SOP ADCR-2, CCR Participant 
Registration & Status Updates found at 
https://ccrod.cancer.gov/confluence/pages/viewpage.action?pageId=73203825.
2.2
COST AND COMPENSATION 
2.2.1
Costs
2.2.2
NIH does not bill health insurance companies or participants for any research or 
related clinical care that participants receive at the NIH Clinical Center.  If some 
tests and procedures are performed outside the NIH Clinical Center, participants 
may have to pay for these costs. Compensation
Please refer to section 3.8.2 of the main protocol.
2.2.3
Reimbursement 
The NCI will cover the costs of some expenses associated with protocol participation.  Some of 
these costs may be paid directly by the NIH and some may be reimbursed to the 
participant/guardian as appropriate.  The amount and form of these payments are determined by 
the NCI Travel and Lodging Reimbursement Policy.  
3
CORRELATIVE STUDIES FOR RESEARCH
3.1
SAMPLE STORAGE, TRACKING AND DISPOSITION
Samples will be ordered in CRIS and tracked through a Clinical Trial Data Management system.  
Should a CRIS screen not be available, the CRIS downtime procedures will be followed.  
Samples will not be sent outside NIH without appropriate approvals and/or agreements, if 
required. 
3.1.1
Laboratory of Pathology
3.1.1.1
Clinical Tissue Samples
Tissues designated for clinical diagnostics are transported to the Laboratory of Pathology (LP) 
where they are examined grossly and relevant portions are fixed, embedded in paraffin and 
sectioned and stained for diagnostic interpretation. Unutilized excess tissue that is not placed in 
paraffin blocks is stored in formalin for up to three months, in accordance with College of 
American Pathologists/Joint Commission on Accreditation of Healthcare Organizations 
(CAP/JCAHO) guidelines, and then discarded. Following completion of the diagnostic workup, 
the slides and tissue blocks are stored indefinitely in the LP’s clinical archives. All specimens are 

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catalogued and retrieved utilizing the clinical laboratory information systems, in accordance with 
CAP/JCAHO regulations. The use of any stored specimens for research purposes is only allowed 
when the appropriate IRB approval has been obtained. In some cases, this approval has been 
obtained via the original protocol on which the participant was enrolled.
3.1.1.2
Research Tissue and Blood Specimen (COMPASS Program)
All FFPE tissues that will undergo molecular pathology testing should be submitted through 
Surgical Pathology. Blood specimen should be delivered to room 3S247 in Building 10 (samples 
will be accepted from 7:30 AM to 4:30 PM Monday to Friday).  Sample storage, tracking and 
disposition procedures will follow laboratory of pathology standard practice (section 3.1.1).
3.1.2
Dr. Wang Laboratory
Surgical resected tumor tissue or needle biopsy core will be received after processing. Tumor 
tissue will be cut into small pieces and dissociated into single cells. For surgical resected tissue, 
part of tissue will be fixed for histological staining and excess tissue frozen down in liquid 
nitrogen. Each collection point may have multiple vials of cells frozen down, depending on the 
total number of cells. For those time points that have multiple vials of enough cells, different 
sequencing (e.g. single cell RNA-seq and ATAC-seq) could be done in parallel. The single cell 
and tissue storage will be recorded in Labmatrix. Records are updated upon sample disposition.
3.1.3
Dr. Jennifer Jones Laboratory
Serum and urine EVP samples will be stored in Dr. Figg’s Biospecimen Processing 
Biorepository and will be analyzed in the Jones Laboratory. Samples will be processed in 
Building 10/B1B51/B1B53 and the LP COMPASS facility, with samples maintained during 
processing in rooms that are locked by badge access to only authorized personnel.
3.1.4
Blood Processing Core (Laboratory of Dr. William Figg)
3.1.4.1
Sample Collection
Remaining tissue samples will be obtained from the laboratory of pathology and stored in Dr. 
Figg’s lab. 
Please e-mail NCIBloodcore@mail.nih.gov at least 24 hours before transporting samples (the 
Friday before is preferred).
For sample pickup, page 102-11964.
For immediate help, call 240-760-6180 (main blood processing core number) or, if no answer, 
240-760-6190 (main clinical pharmacology lab number).
For questions regarding sample processing, contact NCIBloodcore@mail.nih.gov
The samples will be processed, barcoded, and stored in Dr. Figg’s lab until requested by the 
investigator.
3.1.4.2
Sample Data Collection
All samples sent to the Blood Processing Core (BPC) will be barcoded, with data entered and 
stored in Labmatrix utilized by the BPC. This is a secure program, with access to Labmatrix 
limited to defined Figg lab personnel, who are issued individual user accounts. Installation of 

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Labmatrix is limited to computers specified by Dr. Figg. These computers all have a password 
restricted login screen. 
Labmatrix creates a unique barcode ID for every sample and sample box, which cannot be traced 
back to participants without Labmatrix access. The data recorded for each sample includes the 
patient ID, name, trial name/protocol number, time drawn, cycle time point, dose, material type, 
as well as box and freezer location. Participant demographics associated with the Clinical Center 
patient number are provided in the system. For each sample, there are notes associated with the 
processing method (delay in sample processing, storage conditions on the ward, etc.).
3.1.4.3
Sample Storage and Destruction
Barcoded samples are stored in barcoded boxes in a locked freezer at either -20 or -80C 
according to stability requirements.  These freezers are located onsite in the BPC and offsite at 
NCI Frederick Central Repository Services in Frederick, MD. Visitors to the laboratory are 
required to be accompanied by laboratory staff at all times. 
Access to stored clinical samples is restricted. Samples will be stored until requested by a 
researcher named on the protocol. All requests are monitored and tracked in Labmatrix. All 
researchers are required to sign a form stating that the samples are only to be used for research 
purposes associated with this trial (as per the IRB approved protocol) and that any unused 
samples must be returned to the BPC. It is the responsibility of the NCI Principal Investigator to 
ensure that the samples requested are being used in a manner consistent with IRB approval.
Following completion of this study, samples will remain in storage as detailed above. Access to 
these samples will only be granted following IRB approval of an additional protocol, granting 
the rights to use the material. 
If, at any time, a participant withdraws from the study and does not wish for their existing 
samples to be utilized, the individual must provide a written request. Following receipt of this 
request, the samples will be destroyed or returned to the participant, if so requested. The PI will 
record any loss or unanticipated destruction of samples as a deviation. Reporting will be per the 
requirements of section 7.2 of the main protocol.
Sample barcodes are linked to participant demographics and limited clinical information. This 
information will only be provided to investigators listed on this protocol, via registered use of the 
Labmatrix. It is critical that the sample remains linked to participant information such as race, 
age, dates of diagnosis and death, and histological information about the tumor, in order to 
correlate genotype with these variables.
3.1.5
CCR Sequencing Facility 
RNA samples should be transported in dry ice. The names on the tubes are checked against the 
sample manifest and stored in a -80C freezer. Sample data is entered in LIMS once samples 
have undergone a quality check (QC) according to established lab protocols. A sample QC report 
is generated and sent to the PI. LIMS labels are generated from the QC data and used to re-label 
the sample tubes. Once the QC is complete, samples are stored into the library construction box 
in the -80C freezer. 
The libraries are generated either manually or using automation following the established library 
prep protocol. Any leftover RNA is stored in the -80C freezer. If the libraries pass QC, a 

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dilution of the library is passed on for qPCR and sequencing, and the library is stored along with 
the original RNA sample in the same box at -80C. Each step is documented in a tracking sheet 
and LIMS.
The library dilutions are all stored at -30C until sequencing is completed. Once the sequencing 
data is delivered, RNA samples and libraries are sent back to the PI. 
4
NCI CLINICAL DIRECTOR REPORTING 
Problems expeditiously reviewed by the OHSRP in the NIH eIRB system will also be reported to 
the NCI Clinical Director/designee; therefore, a separate submission for these reports is not 
necessary.
In addition to those reports, all deaths that occur within 30 days after receiving a research 
intervention should be reported via email unless they are due to progressive disease.  
To report these deaths, please send an email describing the circumstances of the death to 
NCICCRQA@mail.nih.gov within one business day of learning of the death.
5
CONSENT DOCUMENTATION WHEN ELECTRONIC CONSENT DOCUMENT 
USED AT NIH
Manual (non-electronic) signature on electronic document:
When a manual signature on an electronic document is used for the documentation of consent at 
the NIH Clinical Center, this study will use the following to obtain the required signatures:

Adobe platform (which is not 21 CFR Part 11 compliant); or,  

iMedConsent platform (which is 21 CFR Part 11 compliant)
During the consent process, participants and investigators will view individual copies of the 
approved consent document on screens at their respective locations (if remote consent); the same 
screen may be used when in the same location but is not required.  
Both the investigator and the participant will sign the document using a finger, stylus or mouse. 
Note: Refer to the CCR SOP PM-2, Obtaining and Documenting the Informed Consent Process 
for additional information (e.g., verification of participant identity when obtaining consent 
remotely) 
found 
 
at 
https://ccrod.cancer.gov/confluence/pages/viewpage.action?pageId=73203825.