Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection
|ClinicalTrials.gov Identifier: NCT01572701|
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : November 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: 99mTc-MIP-1404||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||June 2012|
|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
- Tissue distribution of 20 (± 3) mCi 99mTc-MIP-1404 [ Time Frame: Post-procedure ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572701
|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|