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

NCT ID: NCT05141643

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-18
• Study Completion Date: 2026-11-18

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.

Conditions

Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PET Scan

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

18F-FAC PET Scan

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heiko Schoder, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

21-442

Identifier Type: -

Identifier Source: org_study_id