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NCT01654874 · ClinicalTrials.gov registry record · Phase 1
99mTc-MIP-1404 for Imaging Prostate Cancer: Phase I Clinical Study to Assess the Image Quality of a Simplified Kit Formulation Compared to a Multi-step Preparation of 99mTc-MIP-1404
A Phase 1 study, sponsored by Molecular Insight Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01654874 is a Phase 1 study that has completed, run by Molecular Insight Pharmaceuticals. The registered enrollment target is 6 participants.
The verdict
NCT01654874, a Phase 1 study, has completed, sponsored by Molecular Insight Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This trial is a single-blind, cross-over design. Up to three patients with confirmed metastatic prostate adenocarcinoma and up to three healthy volunteers will receive two doses of 20.0 (± 3) mCi of intravenously administered 99mTc MIP 1404 (preparation A or preparation B). Whole-body planar scintigraphic images will be acquired at various time points on the day of study drug administration. A pelvic SPECT/CT image will be acquired on the day of study drug administration. Blood will be collected for pharmacokinetic measurements following study drug administration. Each participant will receive an initial study drug administration (preparation A) and a second study drug administration (preparation B) approximately 7 to 21 days later. A final follow-up visit will occur approximately 2 - 3 weeks after the second study drug administration.
Interventions
- DRUG 99mTc-MIP-1404
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01654874
The ClinicalTrials.gov registry entry for NCT01654874 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 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.
NCT01654874 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01654874 about?
NCT01654874 is a clinical study titled "99mTc-MIP-1404 for Imaging Prostate Cancer: Phase I Clinical Study to Assess the Image Quality of a Simplified Kit Formulation Compared to a Multi-step Preparation of 99mTc-MIP-1404". This trial is a single-blind, cross-over design. Up to three patients with confirmed metastatic prostate adenocarcinoma and up to three healthy volunteers will receive two doses of 20.0 (± 3) mCi of intravenously administered 99mTc MIP 1404 (preparation A or preparation B). Whole-body planar scintig...
What is the current status of trial NCT01654874?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2012-07.
What interventions are being tested in trial NCT01654874?
The interventions under investigation include: 99mTc-MIP-1404 (DRUG).
Who is sponsoring clinical trial NCT01654874?
This trial is sponsored by Molecular Insight Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
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