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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 is a Phase 2 study that has completed, run by SOFIE. The registered enrollment target is 63 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05262855
The ClinicalTrials.gov registry entry for NCT05262855 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SOFIE, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which [68Ga]FAPI-46 is the first listed.
NCT05262855 reports 0 study locations.
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.
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