A Phase 1 Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging to Histology in Men With Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Drug: 99mTc MIP 1404
- Registration Number
- NCT01615406
- Lead Sponsor
- Molecular Insight Pharmaceuticals, Inc.
- Brief Summary
This is a single arm, open label study of up to 24 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. 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
- 9
- Male aged 21 years or older.
- Ability to provide signed informed consent and willingness to comply with protocol requirements.
- Past biopsy indicating the presence of adenocarcinoma of the prostate gland.
- Participant is deemed to have tissue suspicious of prostate cancer involvement that is amenable to biopsy/resection.
- Have had, or will undergo diagnostic CT or MRI imaging prior to surgery.
- 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 study drug administration, 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 Drug: 99mTc-MIP-1404 99mTc MIP 1404 20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404
- Primary Outcome Measures
Name Time Method Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate Within 3-6 hours of dosing SPECT/CT images will be taken Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of the prostate (as determined by histopathology) in patients undergoing standard of care prostatectomy
- Secondary Outcome Measures
Name Time Method Safety of 99mTc-MIP-1404 will be assessed by measuring Vital Signs (blood pressure and heart rate)Pre-Dose and Post-Dose as well as between 3-6 hours post-dose Vital signs measurements will be taken, an expected average of 30 minutes before and after study drug injection and between 3-6 hours after study drug injection Summary tables will present change from pre-dose to post-dose vital signs measurements.
Tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of pelvic lymph node Within 3-6 hours of dosing SPECT/CT images will be taken To obtain exploratory tissue distribution of 99mTc-MIP-1404 SPECT/CT imaging in tumor and non-tumorous regions of pelvic lymph node
Intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression PSMA expression analysis will be conducted upon completion of enrollment Evaluate the intensity of 99mTc-MIP-1404 uptake with respect to PSMA expression
Trial Locations
- Locations (1)
The University of Texas Health Science Center - Houston
🇺🇸Houston, Texas, United States