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
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Ability of 99mTc-MIP-1404 to detect prostate cancer within the prostate gland.
Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate and pelvic lymph nodes(as determined by histopathology) in patients undergoing standard of care prostatectomy with extended pelvic lymph node dissection. Pathology results will be used as the truth standard for all imaging analyses.
Within 3-6 hours of dosing SPECT/CT images will be taken
Douglas Scherr, M.D.
New York Presbyterian Hospital - Cornell
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|
|Medical University of South Carolina||Charleston, South Carolina 29425-0721|
|University of Washington School of Medicine||Seattle, Washington 98195|
|Duke University Medical Center||Durham, North Carolina 27710|
|City of Hope National Cancer Center||Duarte, California 91010|
|University of Wisconsin||Madison,, Wisconsin 53792-5666|
|New York Presbyterian Hospital - Cornell||New York City, New York 10021|
|Glickman Urology & Kidney Institute, Cleveland Clinic||Cleveland, Ohio 44195|
|Thomas Jefferson University / Jefferson Urology Associates||Philadelphia, Pennsylvania 19107|
|University of Texas Vanguard Urologic Research Foundation||Houston, Texas 77030|