Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041
Sponsor
Five Eleven Pharma, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02826382
Collaborator
(none)
30
1
2
75.4
0.4
Study Details
Study Description
Brief Summary
A phase1 study to demonstrate [68Ga]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Early Phase 1 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Preliminary Evaluation of Uptake in Bone Metastases, Biodistribution and Excretion of the Novel Radiotracer [68Ga]P15-041 by PET/CT
Actual Study Start Date
:
Sep 20, 2016
Anticipated Primary Completion Date
:
Dec 1, 2022
Anticipated Study Completion Date
:
Jan 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dynamic imaging group Dynamic imaging of suspected bone metastases with the investigation drug [68Ga]P15-041 |
Drug: [68Ga]P15-041
Imaging by Positron Emission Tomography after injection of [68Ga]P15-041
|
| Experimental: Whole body dosimetry group Determination of human dosimetry of the investigation drug [68Ga]P15-041 |
Drug: [68Ga]P15-041
Imaging by Positron Emission Tomography after injection of [68Ga]P15-041
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pennsylvania | Philadelphia | Pennsylvania | United States |
Sponsors and Collaborators
- Five Eleven Pharma, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Five Eleven Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT02826382
Other Study ID Numbers:
- 511-0001-A
First Posted:
Jul 11, 2016
Last Update Posted:
May 2, 2022
Last Verified:
Apr 1, 2022