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Clinical Trial Details

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Brief Title Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer
Official Title A Phase 3 Study to Evaluate the Safety and Efficacy of 99mTc-MIP-1404 SPECT/CT Imaging to Detect Clinically Significant Prostate Cancer in Men With Biopsy Proven Low-Grade Prostate Cancer Who Are Candidates for Active Surveillance (proSPECT-AS)
Principal Investigator Eggener, Scott
Brief 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.
Gender Male
Ages 18 Years
Enrollment 450
Accepts Healthy Volunteers No
Lead Sponsor Molecular Insight Pharmaceuticals, Inc.Industry
Collaborator
Study Design
Study Phase Phase 3
Study Type Interventional
Contact Name Bertram Yuh, MD
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Prostate Cancer
Detail for Health Professional (on clinicaltrials.gov)
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