Trials / Completed
CompletedNCT05641896
Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
A Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 109 (actual)
- Sponsor
- SOFIE · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Gastrointestinal Cancers
- Cholangiocarcinoma
- Gastric Cancer
- Colorectal Cancer
- Pancreatic Ductal Adenocarcinoma
- Hepatocellular Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | [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. |
Timeline
- Start date
- 2023-04-28
- Primary completion
- 2025-06-30
- Completion
- 2025-06-30
- First posted
- 2022-12-08
- Last updated
- 2026-01-22
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05641896. Inclusion in this directory is not an endorsement.