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NCT04186819 · ClinicalTrials.gov registry record · Phase 3
Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer.
A Phase 3 study, sponsored by Blue Earth Diagnostics.
- Completed
- Registry status
- Phase 3
- Development phase
- 356
- Enrollment target
NCT04186819: Completed Phase 3 study, sponsored by Blue Earth Diagnostics.
NCT04186819 is a Phase 3 study that has completed, run by Blue Earth Diagnostics. The registered enrollment target is 356 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04186819, a Phase 3 study, has completed, sponsored by Blue Earth Diagnostics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 356 participants
- Enrollment target
Study Summary
A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand in men with newly diagnosed prostate cancer.
Primary Outcome
The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.
Interventions
- DRUG rhPSMA-7.3 (18F) Injection
- DIAGNOSTIC_TEST Positron Emission Tomography scan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2020-03-02 |
| Est. Completion | 2021-06-21 |
| Phase | Phase 3 |
What the finished NCT04186819 record still lists
NCT04186819 is an interventional study that assigns participants to a tested intervention. The registered 356 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 (54% lower).
The record links to 0 conditions, and to 2 interventions - of which rhPSMA-7.3 (18F) Injection is the first listed.
NCT04186819 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04186819 about?
NCT04186819 is a clinical study titled "Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer.". A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand in men with newly diagnosed prostate cancer.
What is the current status of trial NCT04186819?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 356 participants. The study started on 2020-03-02. Estimated completion is 2021-06-21.
What interventions are being tested in trial NCT04186819?
The interventions under investigation include: rhPSMA-7.3 (18F) Injection (DRUG), Positron Emission Tomography scan (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04186819?
This trial is sponsored by Blue Earth Diagnostics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04186819's enrollment target sits among peer trials
356 1024th of 2000 higher than 976 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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