Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection
- Registration Number
- NCT01572701
- Lead Sponsor
- Molecular Insight Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
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Male aged 21 years or older.
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Ability to provide signed informed consent and willingness to comply with protocol requirements.
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Past biopsy indicating the presence of adenocarcinoma of the prostate gland.
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Participant is deemed to be high-risk with potential for pelvic lymph node involvement. The criteria for high-risk are:
- Patient has PSA value >10 and clinical stage T2 or higher, and Gleason score 8, 9 or 10.
- Patient has PSA value >20 and clinical stage T2 or higher, and Gleason score
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Participant is or will be scheduled to undergo standard of care prostatectomy and/or pelvic lymph node dissection.
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Have had (within previous 2 months) or will undergo diagnostic CT or MRI imaging prior to surgery.
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Have had (within previous 2 months) or will undergo bone scan imaging prior to surgery.
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Participants must agree to use an acceptable form of birth control throughout the study period. Participants must use condoms for a period of seven days after each injection, if engaged in sexual activity.
- Participants for whom participating would significantly delay the scheduled standard of care therapy.
- Participants administered a radioisotope within 5 physical half lives prior to study enrollment.
- Participants with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 20 (±3) mCi of study drug 99mTc-MIP-1404 -
- Primary Outcome Measures
Name Time Method Tissue distribution of 20 (± 3) mCi 99mTc-MIP-1404 Post-procedure 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
- Secondary Outcome Measures
Name Time Method Safety of 99mTc-MIP-1404: Change in Vital Signs from Pre-Dose to Post-Dose 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 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) 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.
Trial Locations
- Locations (1)
Weill Cornell Medical College
🇺🇸New York, New York, United States