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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05141643

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Pancreatic Ductal Adenocarcinoma	Diagnostic Test: PET Scan	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Nov 18, 2021

Anticipated Primary Completion Date :

Nov 18, 2024

Anticipated Study Completion Date :

Nov 18, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants with pancreatic ductal adenocarcinoma (PDAC) 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 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. Other Names: 18F-FAC PET Scan

Arm

Intervention/Treatment

Experimental: Participants with pancreatic ductal adenocarcinoma (PDAC)

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

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.

Other Names:

18F-FAC PET Scan

Outcome Measures

Primary Outcome Measures

Tumor drug uptake within PDAC tumors prior at pre-treatment baseline [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

Secondary Outcome Measures

changes in [18F]-FAC drug uptake during or following SOC chemo- and/or radiation therapy. [2 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.