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

SOFIE

Status and phase

Completed

Phase 2

Conditions

Gastric Cancer

Hepatocellular Carcinoma

Cholangiocarcinoma

Pancreatic Ductal Adenocarcinoma

Colorectal Cancer

Gastrointestinal Cancers

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT05641896

18FFAPI-2023P2

Details and patient eligibility

About

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.

Enrollment

109 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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