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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer

Treatments: Diagnostic Test: PET Scan

Study type: Interventional

Funder types: Other

Identifiers

NCT05141643

21-442

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Exclusion criteria

• Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia).
• Women who are pregnant or breast-feeding.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Participants with pancreatic ductal adenocarcinoma (PDAC)

Experimental group

Description:

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.

Treatment:

Diagnostic Test: PET Scan