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NCT03396874 · ClinicalTrials.gov registry record · Phase 2
Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
A Phase 2 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,435
- Enrollment target
NCT03396874: Completed Phase 2 study, sponsored by University of Michigan.
NCT03396874 is a Phase 2 study that has completed, run by University of Michigan. The registered enrollment target is 1,435 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (979% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03396874, a Phase 2 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,435 participants
- Enrollment target
Study Summary
This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate cancer cells. Together with a PET/CT scanner, the distribution of 68Ga-PSMA can be determined in the body. To test this new drug, participants will receive an intravenous injection of Ga-68-PSMA and then have a PET/CT scan. The scan results will be made available to study participants and treating physicians.
Primary Outcome
Evaluation of the positive predictive value (PPV) (true positives / (true positives + false positives)) of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by histopathology on a per-patient basis. On a per-patient basis, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%. The result of a histopathological examination of a PSMA positive lesion is obtained w
Interventions
- DRUG 68Ga-PSMA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,435 participants |
| Start Date | 2018-02-09 |
| Est. Completion | 2022-08-09 |
| Phase | Phase 2 |
What the finished NCT03396874 record still lists
NCT03396874 is an interventional study that assigns participants to a tested intervention. Its 1,435 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (979% higher).
The record links to 0 conditions, and to 1 intervention - of which 68Ga-PSMA is the first listed.
NCT03396874 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03396874 about?
NCT03396874 is a clinical study titled "Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence". This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate cancer cells. Together with a PET/CT scanner, the distribution of 68Ga-PSMA can be determined in the body. To test thi...
What is the current status of trial NCT03396874?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,435 participants. The study started on 2018-02-09. Estimated completion is 2022-08-09.
What interventions are being tested in trial NCT03396874?
The interventions under investigation include: 68Ga-PSMA (DRUG).
Who is sponsoring clinical trial NCT03396874?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03396874's enrollment target sits among peer trials
1,435 12th of 2000 higher than 1,989 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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