Ignite Creation Date:
2024-05-06 @ 7:52 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02615067
Status:
COMPLETED
Last Update Posted:
2019-04-10
First Post:
2015-11-20
Brief Title:
Study to Evaluate 99mTc-MIP-1404 SPECTCT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer
Sponsor:
Molecular Insight Pharmaceuticals Inc
Organization:
Molecular Insight Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 3 Study to Evaluate the Safety and Efficacy of 99mTc-MIP-1404 SPECTCT Imaging to Detect Clinically Significant Prostate Cancer in Men With Biopsy Proven Low-Grade Prostate Cancer Who Are Candidates for Active Surveillance proSPECT-AS
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
proSPECT-AS
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 34 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 SPECTCT imaging to correctly identify subjects with previously unknown clinically significant prostate cancer
Detailed Description:
This is a multi-center multi-reader open-label trial comparing 99mTc-MIP-1404 SPECTCT imaging in men who have had a diagnostic trans-rectal ultrasound TRUS guided biopsy with a histopathologic finding of Gleason score 34 who are candidates for active surveillance and are undergoing routine biopsy or voluntary RP with or without a pelvic lymph node dissection PLND This study will evaluate the sensitivity and specificity of 99mTc-MIP-1404 SPECTCT image assessments to correctly identify subjects with previously unknown clinically significant prostate cancer in two cohorts 1 Low grade prostate cancer who have elected to undergo RP Cohort A and 2 very low risk VLR prostate cancer per 2016 NCCN Guidelines who are scheduled to undergo routine prostate biopsy Cohort B
Subjects will receive a single dose of 99mTc-MIP-1404 Injection study drug followed by whole body planar and SPECTCT pelvic imaging 3-6 hours after injection In accordance with standard of care procedures subjects will undergo either voluntary RP Cohort A or prostate biopsy Cohort B within 42 days after study drug dosing 99mTc-MIP-1404 image data will be collected by a central imaging core laboratory and evaluated for visible uptake within the prostate gland These findings will then be compared against central histopathology as the truth standard The central imaging core lab independent readers for the SPECTCT scans will be blinded to all clinical data including pathology results Likewise central pathologists are to remain blinded to all clinical data including imaging results
Subjects will receive a single dose of 99mTc-MIP-1404 Injection study drug followed by whole body planar and SPECTCT pelvic imaging 3-6 hours after injection In accordance with standard of care procedures subjects will undergo either voluntary RP Cohort A or prostate biopsy Cohort B within 42 days after study drug dosing 99mTc-MIP-1404 image data will be collected by a central imaging core laboratory and evaluated for visible uptake within the prostate gland These findings will then be compared against central histopathology as the truth standard The central imaging core lab independent readers for the SPECTCT scans will be blinded to all clinical data including pathology results Likewise central pathologists are to remain blinded to all clinical data including imaging results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None