Cholangiocarcinoma, Colorectal Cancer, Gastric Cancer, Gastrointestinal Cancers, Hepatocellular Carcinoma, Pancreatic Ductal Adenocarcinoma
Conditions
Keywords
Fibroblast Activation Protein, Fibroblast Activation Protein Inhibitor, FAPI, Gastrointestinal Cancer
Brief 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.
Interventions
\[18F\]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.
Sponsors
SOFIE
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for FAP analysis. | Through study completion, 2 years | Lesions positive for FAP as detected by immunohistochemistry and Lesions positive for FAP as detected by \[18F\]FAPI-74 PET imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for histopathology. | Through study completion, 2 years | Malignant lesions as detected by histopathology and Lesions positive for FAP as detected by \[18F\]FAPI-74 PET imaging |
| Further characterize the safety profile of [18F]FAPI-74 in subjects utilizing Common Terminology Criteria for Adverse Events (CTCAE v5) | Through study completion, 2 years | Incidence and severity of treatment emergent adverse events occurring within 24 hours. |
Countries
United States
Outcome results
None listed