Imaging Study of 18F-FAC PET Scans to Assess Standard Treatment in People With Pancreatic Cancer
18F-FAC PET Imaging to Quantify Gemcitabine Tumor Drug Uptake and Biodistribution in Pancreatic Cancer Patients
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to find out whether a pre-treatment PET scan using the experimental imaging tracer 18F-FAC can show how much of the standard chemotherapy for PDAC may be taken up by the cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 pancreatic-cancer
Started Nov 2021
Longer than P75 for early_phase_1 pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 18, 2021
CompletedFirst Submitted
Initial submission to the registry
November 19, 2021
CompletedFirst Posted
Study publicly available on registry
December 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 18, 2026
September 4, 2025
August 1, 2025
5 years
November 19, 2021
August 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tumor drug uptake within PDAC tumors prior at pre-treatment baseline
The primary objective of this study is to obtain preliminary data of tumor drug uptake profile, concentration and distribution within PDAC tumors prior at pre-treatment baseline
Baseline
Secondary Outcomes (1)
changes in [18F]-FAC drug uptake during or following SOC chemo- and/or radiation therapy.
2 years
Study Arms (1)
Participants with pancreatic ductal adenocarcinoma (PDAC)
EXPERIMENTALParticipants will have histologically-confirmed pancreatic ductal adenocarcinoma (PDAC). The experimental design of this study is to perform a single \[18F\]-FAC PET scan prior to the administration of chemotherapy with an optional second \[18F\]-FAC PET scan procedure during SOC treatment to observe changes in tumor uptake and biodistribution. Patients will be offered a second \[18F\]-FAC PET scan procedure during their SOC treatment. This second scan will be optional.
Interventions
Participants will receive a minimum of 4 mCi (148 MBq) and up to a maximum of 10 mCi (370 MBq) of \[18F\]-FAC intravenously. Injection is performed in conjunction with a dynamic PET acquisition over a site of the disease (pre-selected based on the findings from a previous CT or MRI and FDG PET/CT study done for clinical purpose such as staging). Patients will be offered a second \[18F\]-FAC PET scan procedure during their SOC treatment. This second scan will be optional.
Eligibility Criteria
You may qualify if:
- Patients with histologically-confirmed (confirmed at MSKCC) PDAC
- Patients must be ≥ 18 years old
- Signed, written Institutional Review Board (IRB)-approved Informed Consent Form (ICF).
- Measurable or evaluable solid disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST v1.1.
- Karnofsky Performance Status ≥70%.
- Life expectancy ≥3 months.
- A negative serum pregnancy test, within 1 week of the procedure, if the patient is female of reproductive potential.
You may not qualify if:
- Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia).
- Women who are pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heiko Schoder, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2021
First Posted
December 2, 2021
Study Start
November 18, 2021
Primary Completion (Estimated)
November 18, 2026
Study Completion (Estimated)
November 18, 2026
Last Updated
September 4, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.