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NCT03113617 · ClinicalTrials.gov registry record · Phase 2
68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer
A Phase 2 study, sponsored by Andrei Iagaru.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT03113617: Completed Phase 2 study, sponsored by Andrei Iagaru.
NCT03113617 is a Phase 2 study that has completed, run by Andrei Iagaru. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03113617, a Phase 2 study, has completed, sponsored by Andrei Iagaru.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
This phase II trial studies how well gallium Ga 68-labeled gastrin-releasing peptide receptor (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/computed tomography (CT) works in detecting regional nodal and distant metastases in patients with intermediate or high-risk prostate cancer. 68Ga-RM2 PET/CT scan may be able to see smaller tumors than the standard of care CT or magnetic resonance imaging scan.
Primary Outcome
True positive patient is defined as PET positive for regional nodes, pathology at prostatectomy positive for regional nodes or PET positive for regional nodes, pathology negative for regional nodes, imaging after prostatectomy demonstrates node was not removed at surgery, and follow-up biopsy or imaging demonstrates presence of nodal disease. True negative patient is defined as PET negative for regional nodes, pathology at prostatectomy negative for regional nodes. False positive patient is defi
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- OTHER Laboratory Biomarker Analysis
- DRUG Gallium Ga 68-labeled GRPR Antagonist BAY86-7548
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2017-04-10 |
| Est. Completion | 2021-12-19 |
| Phase | Phase 2 |
What the finished NCT03113617 record still lists
NCT03113617 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 4 interventions - of which Computed Tomography is the first listed.
NCT03113617 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03113617 about?
NCT03113617 is a clinical study titled "68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer". This phase II trial studies how well gallium Ga 68-labeled gastrin-releasing peptide receptor (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/computed tomography (CT) works in detecting regional nodal and distant metastases in patients with intermediate or high-risk prosta...
What is the current status of trial NCT03113617?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2017-04-10. Estimated completion is 2021-12-19.
What interventions are being tested in trial NCT03113617?
The interventions under investigation include: Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Laboratory Biomarker Analysis (OTHER), Gallium Ga 68-labeled GRPR Antagonist BAY86-7548 (DRUG).
Who is sponsoring clinical trial NCT03113617?
This trial is sponsored by Andrei Iagaru, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03113617's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 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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