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NCT01572701 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection
A Phase 1 study, sponsored by Molecular Insight Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01572701 is a Phase 1 study that has completed, run by Molecular Insight Pharmaceuticals. The registered enrollment target is 8 participants.
The verdict
NCT01572701, a Phase 1 study, has completed, sponsored by Molecular Insight Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a single arm, open label study of up to 24 high risk 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. Patients may receive a second injection of study drug within 24 hours of surgery to measure activity counts in tissue samples post-surgery, but prior to pathology processing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
Interventions
- DRUG 99mTc-MIP-1404
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2012-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01572701
The ClinicalTrials.gov registry entry for NCT01572701 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Molecular Insight Pharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 99mTc-MIP-1404 is the first listed.
NCT01572701 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01572701 about?
NCT01572701 is a clinical study titled "Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection". This is a single arm, open label study of up to 24 high risk 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 w...
What is the current status of trial NCT01572701?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2012-01.
What interventions are being tested in trial NCT01572701?
The interventions under investigation include: 99mTc-MIP-1404 (DRUG).
Who is sponsoring clinical trial NCT01572701?
This trial is sponsored by Molecular Insight Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
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