Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection
This is a single arm, open label study of up to 24 high risk prostate cancer patients scheduled for prostatectomy and/or 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/or pelvic lymph node dissection (PLND) within two weeks of study drug dosing. Patients may receive a second injection of study drug within 24 hours of surgery to measure activity counts in tissue samples post-surgery, but prior to pathology processing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Phase 1 Pilot Study of 99mTc-MIP-1404 Single Photon Emission Computed Tomography (SPECT)/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection (PLND)|
- Tissue distribution of 20 (± 3) mCi 99mTc-MIP-1404 [ Time Frame: Post-procedure ] [ Designated as safety issue: No ]99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
- Safety of 99mTc-MIP-1404: Change in Vital Signs from Pre-Dose to Post-Dose [ Time Frame: Vital signs measurements will be measured, an expected average of 30 minutes before and after study drug injection ] [ Designated as safety issue: No ]Summary tables will present change from pre-dose to post-dose vital signs measurements.
- Intensity of 99mTc-MIP-1404 Uptake with Respect to PSMA expression [ Time Frame: Post-procedure ] [ Designated as safety issue: No ]99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
- Safety of 99mTc-MIP-1404: Summary of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Adverse events will be assessed for the duration of the study participation, an expected average of 3 weeks ] [ Designated as safety issue: No ]TEAEs will be summarized by the Medical Dictionary for Regulatory Activities (MedDRA) body system and preferred term, by intensity, and by causal relationship to study agent.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||April 2013|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
|Experimental: 20 (±3) mCi of study drug||
20 (±3) mCi of study drug will be administered by IV injection as a slow bolus and flushed with approximately 10 mL of saline
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|Principal Investigator:||Douglas S Scherr, MD||New York Presbyterian Hospital - Weill Medical College of Cornell University|