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

Colorectal Cancer Clinical Trial

— 18F-FAPI-74 GI  

Official title:

A Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05641896
• Other study ID #: 18FFAPI-2023P2
• Status: Recruiting
• Phase: Phase 2
• Start date: April 28, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: SOFIE
• Contact: Sherly Mosessian, Ph.D
• Phone: 818-400-7620
• Email: sherly.mosessian[@]sofie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 31, 2025
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

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 gastrointestinal cancers.

Locations

Country	Name	City	State
United States	Massachusetts general hospital	Boston	Massachusetts
United States	BAMF Health	Grand Rapids	Michigan
United States	Northwell Health	Lake Success	New York
United States	University of California Los Angeles (UCLA) Health	Los Angeles	California
United States	Memorial Sloan Kettering Cancer Center (MSKCC)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
SOFIE

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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