Clinical trial NCT05641896: Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
Official title: A Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Gastrointestinal Cancers
Cholangiocarcinoma
Gastric Cancer
Colorectal Cancer
Pancreatic Ductal Adenocarcinoma
Hepatocellular Carcinoma
Keywords: Fibroblast Activation Protein
Fibroblast Activation Protein Inhibitor
FAPI
Gastrointestinal Cancer
Lead sponsor: SOFIE
Sponsor class: INDUSTRY
First posted: 2022-12-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for FAP analysis.
timeFrame: Through study completion, 2 years
Secondary outcomes:
measure: Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for histopathology.
timeFrame: Through study completion, 2 years
measure: Further characterize the safety profile of [18F]FAPI-74 in subjects utilizing Common Terminology Criteria for Adverse Events (CTCAE v5)
timeFrame: Through study completion, 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles (UCLA) Health
state: California
city: Boston
country: United States
facility: Massachusetts general hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: BAMF Health
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Lake Success
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (MSKCC)
state: New York
Study officials:
References: