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NCT02615067 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer
A Phase 3 study, sponsored by Molecular Insight Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 531
- Enrollment target
NCT02615067: Completed Phase 3 study, sponsored by Molecular Insight Pharmaceuticals.
NCT02615067 is a Phase 3 study that has completed, run by Molecular Insight Pharmaceuticals. The registered enrollment target is 531 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02615067, a Phase 3 study, has completed, sponsored by Molecular Insight Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 531 participants
- Enrollment target
Study Summary
99mTc-MIP-1404 is a radioactive diagnostic imaging agent indicated for imaging men with newly diagnosed prostate cancer whose biopsy indicates a histopathologic Gleason Score of ≤ 3+4 severity who are candidates for active surveillance and are undergoing voluntary radical prostatectomy (RP) \[Cohort A\] or routine prostate biopsy \[Cohort B\]. This Phase 3 study is designed to evaluate the specificity and sensitivity of 99mTc-MIP-1404 SPECT/CT imaging to correctly identify subjects with previously unknown clinically significant prostate cancer.
Primary Outcome
Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate and pelvic lymph nodes, if applicable, (as determined by histopathology) in patients undergoing RP (with or without extended pelvic lymph node dissection) or routine prostate biopsy. Pathology results will be used as the truth standard for all imaging analyses.
Interventions
- DRUG 99mTc-MIP-1404 Injection
- DIAGNOSTIC_TEST Whole-Body Planar and pelvic SPECT/CT scan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 531 participants |
| Start Date | 2015-12 |
| Est. Completion | 2017-12-28 |
| Phase | Phase 3 |
What the finished NCT02615067 record still lists
NCT02615067 is an interventional study that assigns participants to a tested intervention. The registered 531 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 (31% lower).
The record links to 0 conditions, and to 2 interventions - of which 99mTc-MIP-1404 Injection is the first listed.
NCT02615067 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02615067 about?
NCT02615067 is a clinical study titled "Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer". 99mTc-MIP-1404 is a radioactive diagnostic imaging agent indicated for imaging men with newly diagnosed prostate cancer whose biopsy indicates a histopathologic Gleason Score of ≤ 3+4 severity who are candidates for active surveillance and are undergoing voluntary radical prostatectomy (RP) \[Cohort...
What is the current status of trial NCT02615067?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 531 participants. The study started on 2015-12. Estimated completion is 2017-12-28.
What interventions are being tested in trial NCT02615067?
The interventions under investigation include: 99mTc-MIP-1404 Injection (DRUG), Whole-Body Planar and pelvic SPECT/CT scan (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT02615067?
This trial is sponsored by Molecular Insight Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02615067's enrollment target sits among peer trials
531 704th of 2000 higher than 1,295 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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