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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic Test
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
United States
New York
Memorial Sloan Kettering Cancer Center
Recruiting
New York
Contact Information
Primary
Heiko Schoder, MD
schoderh@mskcc.org
212-639-2079
Backup
John Humm, PhD
hummj@mskcc.org
212-639-7367
Time Frame
Start Date: November 18, 2021
Estimated Completion Date: November 18, 2024
Participants
Target number of participants: 30
Treatments
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.
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov

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