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NCT03353740 · ClinicalTrials.gov registry record · Phase 3
Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence
A Phase 3 study, sponsored by Thomas Hope.
- Completed
- Registry status
- Phase 3
- Development phase
- 346
- Enrollment target
NCT03353740: Completed Phase 3 study, sponsored by Thomas Hope.
NCT03353740 is a Phase 3 study that has completed, run by Thomas Hope. The registered enrollment target is 346 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03353740, a Phase 3 study, has completed, sponsored by Thomas Hope.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 346 participants
- Enrollment target
Study Summary
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.
Primary Outcome
The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.
Interventions
- DRUG Ga-68 labeled PSMA-11 PET
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 346 participants |
| Start Date | 2017-09-20 |
| Est. Completion | 2020-09-01 |
| Phase | Phase 3 |
What the finished NCT03353740 record still lists
NCT03353740 is an interventional study that assigns participants to a tested intervention. The registered 346 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which Ga-68 labeled PSMA-11 PET is the first listed.
NCT03353740 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03353740 about?
NCT03353740 is a clinical study titled "Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence". The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.
What is the current status of trial NCT03353740?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 346 participants. The study started on 2017-09-20. Estimated completion is 2020-09-01.
What interventions are being tested in trial NCT03353740?
The interventions under investigation include: Ga-68 labeled PSMA-11 PET (DRUG).
Who is sponsoring clinical trial NCT03353740?
This trial is sponsored by Thomas Hope, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03353740's enrollment target sits among peer trials
346 1049th of 2000 higher than 951 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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