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NCT05262855 · ClinicalTrials.gov registry record · Phase 2
Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma
A Phase 2 study, sponsored by SOFIE.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT05262855: Completed Phase 2 study, sponsored by SOFIE.
NCT05262855 is a Phase 2 study that has completed, run by SOFIE. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05262855, a Phase 2 study, has completed, sponsored by SOFIE.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
This is a prospective, multi-center, single arm, open label, non-randomized study to evaluate the ability of \[68Ga\]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The \[68Ga\]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. If the participant is prescribed neoadjuvant therapy, a second \[68Ga\]FAPI-46 PET scan will be performed within 21 days prior to planned surgical resection. This will be followed by histopathology and IHC analyses and comparison to resected PDAC tumor specimens.
Primary Outcome
Sensitivity was defined as the proportion of participants with histopathology-confirmed PDAC who had a positive \[⁶⁸Ga\]FAPI-46 PET result for the primary lesion. Sensitivity was calculated by comparing positive and negative \[⁶⁸Ga\]FAPI-46 PET findings with the corresponding histopathology results, using a single readable PET image matched to its reference histopathology assessment. Sensitivity was calculated as A / (A + C), where A represents true-positive findings and C represents false-negat
Interventions
- DRUG [68Ga]FAPI-46
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2022-05-02 |
| Est. Completion | 2025-11-04 |
| Phase | Phase 2 |
What the finished NCT05262855 record still lists
NCT05262855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which [68Ga]FAPI-46 is the first listed.
NCT05262855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05262855 about?
NCT05262855 is a clinical study titled "Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma". This is a prospective, multi-center, single arm, open label, non-randomized study to evaluate the ability of \[68Ga\]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The \[68Ga\]FAPI-46 PET scans will be acquired after initial staging using institutio...
What is the current status of trial NCT05262855?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2022-05-02. Estimated completion is 2025-11-04.
What interventions are being tested in trial NCT05262855?
The interventions under investigation include: [68Ga]FAPI-46 (DRUG).
Who is sponsoring clinical trial NCT05262855?
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 NCT05262855's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 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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