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NCT01667536 · ClinicalTrials.gov registry record · Phase 2

A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology

A Phase 2 study, sponsored by Molecular Insight Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
105
Enrollment target

NCT01667536: Completed Phase 2 study, sponsored by Molecular Insight Pharmaceuticals.

NCT01667536 is a Phase 2 study that has completed, run by Molecular Insight Pharmaceuticals. The registered enrollment target is 105 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01667536, a Phase 2 study, has completed, sponsored by Molecular Insight Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
105 participants
Enrollment target

Study 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.

Primary Outcome

For the prostate gland, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.

Interventions

  • DRUG Drug: 99mTc-MIP-1404

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2012-08
Est. Completion 2013-12
Phase Phase 2
Molecular Insight Pharmaceuticals

13 total trials

What the finished NCT01667536 record still lists

NCT01667536 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower).

The record links to 0 conditions, and to 1 intervention - of which Drug: 99mTc-MIP-1404 is the first listed.

NCT01667536 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01667536 about?

NCT01667536 is a clinical study titled "A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology". 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 ju...

What is the current status of trial NCT01667536?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2012-08. Estimated completion is 2013-12.

What interventions are being tested in trial NCT01667536?

The interventions under investigation include: Drug: 99mTc-MIP-1404 (DRUG).

Who is sponsoring clinical trial NCT01667536?

This trial is sponsored by Molecular Insight Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01667536's enrollment target sits among peer trials

105 650th of 2000 higher than 1,341 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT01667536, the US trial registry maintained by the National Library of Medicine. NCT01667536 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.