Study Of [18F]FAPI-74 PET In Patients With Gastrointestinal Cancers

Study Overview

Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers

Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of [18F]FAPI-74 to detect FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer. The [18F]FAPI-74 PET scan will be acquired in patients with proven GI cancers after initial staging using institutional standard methods. The PET scan results will be compared to FAP immunohistochemistry (as the primary objective) and histopathology (as the secondary objective) of the biopsied or resected tissues.

N/A

Gastrointestinal Cancers
Cholangiocarcinoma
Gastric Cancer
Colorectal Cancer
Pancreatic Ductal Adenocarcinoma
Hepatocellular Carcinoma

DRUG: [18F]FAPI-74 PET/CT

18FFAPI-2023P2

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-11-29	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-12
First Submitted that Met QC Criteria 2022-11-29	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-15
First Posted (ACTUAL) 2022-12-08	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: [18F]FAPI-74 PET/CT Patients receive [18F]FAPI-74 intravenously followed by PET/CT 60 minutes (+/-10minutes) later	DRUG: [18F]FAPI-74 PET/CT [18F]FAPI-74 is a radioactive diagnostic agent indicated for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF) in patients with gastro

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: [18F]FAPI-74 PET/CT

Patients receive [18F]FAPI-74 intravenously followed by PET/CT 60 minutes (+/-10minutes) later

DRUG: [18F]FAPI-74 PET/CT

[18F]FAPI-74 is a radioactive diagnostic agent indicated for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF) in patients with gastro

Primary Outcome Measures	Measure Description	Time Frame
Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for FAP analysis.	Lesions positive for FAP as detected by immunohistochemistry and Lesions positive for FAP as detected by [18F]FAPI-74 PET imaging	Through study completion, 2 years

Secondary Outcome Measures	Measure Description	Time Frame
Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for histopathology.	Malignant lesions as detected by histopathology and Lesions positive for FAP as detected by [18F]FAPI-74 PET imaging	Through study completion, 2 years
Further characterize the safety profile of [18F]FAPI-74 in subjects utilizing Common Terminology Criteria for Adverse Events (CTCAE v5)	Incidence and severity of treatment emergent adverse events occurring within 24 hours.	Through study completion, 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Confirmed diagnosis of gastrointestinal (GI) malignancy, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer
Available tissue sample obtained through biopsy or to be obtained through scheduled biopsy and/or surgical resection
No treatment received between tissue sample taken and [18F]FAPI-74 PET
Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent
Age ≥ 18 years
Completed informed consent as determined per the IRB of record

Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential
Declining to use effective contraceptive methods during the study (for individuals of child-producing potential)
Need for emergent surgery that would be delayed by participation
Bacterial, viral, or fungal infections requiring systemic therapy, that are expected to impact FAP expression in the opinion of the sponsor or their designee
Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator, physician of record and/or Sofie could compromise subject safety and/or protocol objectives
Known diagnosis of an autoimmune disorder that is expected to impact FAP expression in the opinion of the sponsor or their designee
Patients receiving any other investigational agent within the past 28 days
Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the [18F]FAPI-74 injection
Known hypersensitivity to any excipients used in [18F]FAPI-74: trace amounts of sodium acetate, sodium ascorbate, ascorbic acid, ethanol, acetonitrile or AlCl.
Renal or liver function impairment
*Defined by liver impairments as AST>3x the upper limit of normal, ALT>3x the upper limit of normal, or bilirubin>1.5x the upper limit of normal. Renal impairment as defined by a creatinine clearance of >1.5x the upper limit of normal utilizing the Cockcroft Gault formula

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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General Publications

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Clinical Trial Record