Bone Metastases, Prostate Cancer
Conditions
Brief summary
A phase1 study to demonstrate \[68Ga\]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.
Interventions
DRUG[68Ga]P15-041
Imaging by Positron Emission Tomography after injection of \[68Ga\]P15-041
Sponsors
Five Eleven Pharma, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed