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

Study Overview
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Brief Summary
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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.

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

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

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [18F]FAPI-74 PET/CT<br>Patients receive [18F]FAPI-74 intravenously followed by PET/CT 60 minutes (+/-10minutes) later | Drug: [18F]FAPI-74 PET/CT<br>* [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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibroblast Activation Protein, Fibroblast Activation Protein Inhibitor, FAPI, Gastrointestinal Cancer