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NCT01615406 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer
A Phase 1 study, sponsored by Molecular Insight Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01615406: Completed Phase 1 study, sponsored by Molecular Insight Pharmaceuticals.
NCT01615406 is a Phase 1 study that has completed, run by Molecular Insight Pharmaceuticals. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01615406, a Phase 1 study, has completed, sponsored by Molecular Insight Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is a single arm, open label study of up to 24 prostate cancer patients scheduled for prostatectomy and/or pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and/or pelvic lymph node dissection (PLND) within two weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
Primary Outcome
Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology) in patients undergoing standard of care prostatectomy
Interventions
- DRUG 99mTc MIP 1404
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2012-04 |
| Phase | Phase 1 |
What the finished NCT01615406 record still lists
NCT01615406 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which 99mTc MIP 1404 is the first listed.
NCT01615406 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01615406 about?
NCT01615406 is a clinical study titled "A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer". This is a single arm, open label study of up to 24 prostate cancer patients scheduled for prostatectomy and/or pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will underg...
What is the current status of trial NCT01615406?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2012-04.
What interventions are being tested in trial NCT01615406?
The interventions under investigation include: 99mTc MIP 1404 (DRUG).
Who is sponsoring clinical trial NCT01615406?
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 NCT01615406's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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