Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer
Status:
Completed
Trial end date:
2017-12-28
Target enrollment:
Participant gender:
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.