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

Early Phase 1

Active, not recruiting

• Conditions: Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma
• Interventions: Diagnostic Test: PET Scan

• Registration Number: NCT05141643
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-18
• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-12-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2025-11-18
• Study Completion: 2025-11-18

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with pancreatic ductal adenocarcinoma (PDAC)	PET Scan	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States