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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
8
20 (±3) mCi of study drug will be administered by IV injection as a slow bolus and flushed with approximately 10 mL of saline
Weill Cornell Medical College
New York, New York, United States
Tissue distribution of 20 (± 3) mCi 99mTc-MIP-1404
99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
Time frame: Post-procedure
Safety of 99mTc-MIP-1404: Change in Vital Signs from Pre-Dose to Post-Dose
Summary tables will present change from pre-dose to post-dose vital signs measurements.
Time frame: Vital signs measurements will be measured, an expected average of 30 minutes before and after study drug injection
Intensity of 99mTc-MIP-1404 Uptake with Respect to PSMA expression
99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
Time frame: Post-procedure
Safety of 99mTc-MIP-1404: Summary of Treatment-Emergent Adverse Events (TEAEs)
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.
Time frame: Adverse events will be assessed for the duration of the study participation, an expected average of 3 weeks
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