Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041
- Registration Number
- NCT02826382
- Lead Sponsor
- Five Eleven Pharma, Inc.
- Brief Summary
A phase1 study to demonstrate \[68Ga\]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 14
Inclusion Criteria
- histologically confirmed prostate cancer. known or suspected bone metastases referred for a clinical [99mTc]MDP scan
Exclusion Criteria
- Estimated creatinine clearance (GFR) < 30 mL/min (calculated), history of hyperparathyroidism, • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician, • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dynamic imaging group [68Ga]P15-041 Dynamic imaging of suspected bone metastases with the investigation drug \[68Ga\]P15-041 Whole body dosimetry group [68Ga]P15-041 Determination of human dosimetry of the investigation drug \[68Ga\]P15-041
- Primary Outcome Measures
Name Time Method Time course of uptake of [68Ga]P15-041 in bone metastases 60 minutes post injection kinetics of \[68Ga\]P15-041 uptake in known or suspected bone metastases in prostate cancer
Time course of whole body distribution of [68Ga]P15-041 3 hours post injection whole body distribution of \[68Ga\]P15-041 used for human dosimetry determination
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States