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A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men With High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (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 judged by histopathology results.
This is a single arm, open label study of approximately 100 high-risk prostate cancer patients scheduled for prostatectomy and extended pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and extended pelvic lymph node dissection (EPLND) within three weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
Age
21 - No limit years
Sex
MALE
Healthy Volunteers
No
City of Hope National Cancer Center
Duarte, California, United States
Mayo Clinic
Rochester, Minnesota, United States
New York Presbyterian Hospital - Cornell
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Glickman Urology & Kidney Institute, Cleveland Clinic
Cleveland, Ohio, United States
Thomas Jefferson University / Jefferson Urology Associates
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas Vanguard Urologic Research Foundation
Houston, Texas, United States
University of Washington School of Medicine
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Start Date
August 1, 2012
Primary Completion Date
December 1, 2013
Completion Date
December 1, 2013
Last Updated
February 7, 2017
105
ACTUAL participants
Drug: 99mTc-MIP-1404
DRUG
Lead Sponsor
Molecular Insight Pharmaceuticals, Inc.
NCT04550494
NCT06842498
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05691465