CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 9 enrolled
Drug / intervention
99mTc MIP 1404drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01615406
NCT01615406Phase 1Completed
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A Phase 1 Pilot Comparison Study of 99mTc-MIP-1404 Single Photon Emission Computed Tomography (SPECT)/CT Imaging to Histology in Men With Prostate Cancer

Molecular Insight Pharmaceuticals, Inc.·interventional·Posted Jun 8, 2012·Updated Nov 25, 2015

In Brief

A Phase 1 clinical trial evaluating 99mTc MIP 1404 for Prostate Cancer. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 8, 2012
Enrollment StartApr 1, 2012
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.1 years ago

Interventions

99mTc MIP 1404drug

A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404