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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05141643
• Other study ID #: 21-442
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 18, 2021
• Est. completion date: November 18, 2025

Study information

• Verified date: August 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Heiko Schoder, MD
• Phone: 646-634-2751
• Email: schoderh[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 18, 2025
• Est. primary completion date: November 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Memorial Sloan Kettering Cancer Center