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NCT05641896 · ClinicalTrials.gov registry record · Phase 2
Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
A Phase 2 study, sponsored by SOFIE.
- Completed
- Registry status
- Phase 2
- Development phase
- 109
- Enrollment target
NCT05641896: Completed Phase 2 study, sponsored by SOFIE.
NCT05641896 is a Phase 2 study that has completed, run by SOFIE. The registered enrollment target is 109 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05641896, a Phase 2 study, has completed, sponsored by SOFIE.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 109 participants
- Enrollment target
Study 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.
Primary Outcome
Lesions positive for FAP as detected by immunohistochemistry and Lesions positive for FAP as detected by \[18F\]FAPI-74 PET imaging
Interventions
- DRUG [18F]FAPI-74 PET/CT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2023-04-28 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 2 |
What the finished NCT05641896 record still lists
NCT05641896 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 1 intervention - of which [18F]FAPI-74 PET/CT is the first listed.
NCT05641896 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05641896 about?
NCT05641896 is a clinical study titled "Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers". 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 \[18F\]...
What is the current status of trial NCT05641896?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2023-04-28. Estimated completion is 2025-06-30.
What interventions are being tested in trial NCT05641896?
The interventions under investigation include: [18F]FAPI-74 PET/CT (DRUG).
Who is sponsoring clinical trial NCT05641896?
This trial is sponsored by SOFIE, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05641896's enrollment target sits among peer trials
109 640th of 2000 higher than 1,361 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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