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NCT02615067 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer

A Phase 3 study, sponsored by Molecular Insight Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
531
Enrollment target

NCT02615067 is a Phase 3 study that has completed, run by Molecular Insight Pharmaceuticals. The registered enrollment target is 531 participants.

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The verdict

NCT02615067, a Phase 3 study, has completed, sponsored by Molecular Insight Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
531 participants
Enrollment target

Study Summary

99mTc-MIP-1404 is a radioactive diagnostic imaging agent indicated for imaging men with newly diagnosed prostate cancer whose biopsy indicates a histopathologic Gleason Score of ≤ 3+4 severity who are candidates for active surveillance and are undergoing voluntary radical prostatectomy (RP) \[Cohort A\] or routine prostate biopsy \[Cohort B\]. This Phase 3 study is designed to evaluate the specificity and sensitivity of 99mTc-MIP-1404 SPECT/CT imaging to correctly identify subjects with previously unknown clinically significant prostate cancer.

Interventions

  • DRUG 99mTc-MIP-1404 Injection
  • DIAGNOSTIC_TEST Whole-Body Planar and pelvic SPECT/CT scan

Trial Details

FieldValue
Enrollment Target 531 participants
Start Date 2015-12
Est. Completion 2017-12-28
Phase Phase 3

Sponsor

Molecular Insight Pharmaceuticals

13 total trials

What the Registry Record Tells You About NCT02615067

The ClinicalTrials.gov registry entry for NCT02615067 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 531 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 2 interventions - of which 99mTc-MIP-1404 Injection is the first listed.

NCT02615067 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02615067 about?

NCT02615067 is a clinical study titled "Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer". 99mTc-MIP-1404 is a radioactive diagnostic imaging agent indicated for imaging men with newly diagnosed prostate cancer whose biopsy indicates a histopathologic Gleason Score of ≤ 3+4 severity who are candidates for active surveillance and are undergoing voluntary radical prostatectomy (RP) \[Cohort...

What is the current status of trial NCT02615067?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 531 participants. The study started on 2015-12. Estimated completion is 2017-12-28.

What interventions are being tested in trial NCT02615067?

The interventions under investigation include: 99mTc-MIP-1404 Injection (DRUG), Whole-Body Planar and pelvic SPECT/CT scan (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT02615067?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.