Imaging Study of 18F-FAC PET Scans to Assess Standard Treatment in People With Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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18F-FAC PET Imaging to Quantify Gemcitabine Tumor Drug Uptake and Biodistribution in Pancreatic Cancer Patients

Conditions
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Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Diagnostic Test: PET Scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia). Women who are pregnant or breast-feeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with pancreatic ductal adenocarcinoma (PDAC)<br>Participants 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. | Diagnostic Test: PET Scan<br>* 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.<br>* Other names: 18F-FAC PET Scan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in [18F]-FAC drug uptake during or following SOC chemo- and/or radiation therapy. | To investigate changes in [18F]-FAC drug uptake and distribution during or following SOC chemo- and/or radiation therapy. Based on those patients who agree to undergo the second optional [18F]-FAC PET scan | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Cancer, pancreatic ductal adenocarcinoma, 18F-FAC, Memorial Sloan Kettering Cancer Center, 21-442