Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
NCT ID: NCT05641896
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
109 participants
INTERVENTIONAL
2023-04-28
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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[18F]FAPI-74 PET/CT
Patients receive \[18F\]FAPI-74 intravenously followed by PET/CT 60 minutes (+/-10minutes) later
[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.
Interventions
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[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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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SOFIE
INDUSTRY
Responsible Party
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Locations
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University of California Los Angeles (UCLA) Health
Los Angeles, California, United States
Massachusetts general hospital
Boston, Massachusetts, United States
BAMF Health
Grand Rapids, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Northwell Health
Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York, United States
Countries
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Other Identifiers
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18FFAPI-2023P2
Identifier Type: -
Identifier Source: org_study_id
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