CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 105 enrolled
Drug / intervention
Drug: 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/NCT01667536
NCT01667536Phase 2Completed
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A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men With High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology

Molecular Insight Pharmaceuticals, Inc.·interventional·Posted Aug 17, 2012·Updated Feb 7, 2017

In Brief

A Phase 2 clinical trial evaluating Drug: 99mTc-MIP-1404 for Prostate Cancer. Completed, enrolled 105 participants across 35 sites in 8 countries.

Detailed Summary

This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic lymph node cancer. Comparative performance characteristics between MIP 1404 imaging and MRI were also assessed, as judged by histopathology results.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesBelgium, Czechia, Hungary, Italy, Netherlands, Poland, Russia, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 17, 2012
Enrollment StartAug 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.9 years ago

Interventions

Drug: 99mTc-MIP-1404drug

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