Back to resultsPreliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041
Primary Purpose
Prostate Cancer, Bone Metastases
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
[68Ga]P15-041
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dynamic imaging group
Whole body dosimetry group
Arm Description
Dynamic imaging of suspected bone metastases with the investigation drug [68Ga]P15-041
Determination of human dosimetry of the investigation drug [68Ga]P15-041
Outcomes
Primary Outcome Measures
Time course of uptake of [68Ga]P15-041 in bone metastases
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
whole body distribution of [68Ga]P15-041 used for human dosimetry determination
Secondary Outcome Measures
Full Information
NCT ID
NCT02826382
First Posted
July 5, 2016
Last Updated
January 10, 2023
Sponsor
Five Eleven Pharma, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02826382
Brief Title
Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041
Official Title
A Preliminary Evaluation of Uptake in Bone Metastases, Biodistribution and Excretion of the Novel Radiotracer [68Ga]P15-041 by PET/CT
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2016 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Five Eleven Pharma, Inc.
4. Oversight
5. Study Description
Brief Summary
A phase1 study to demonstrate [68Ga]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Bone Metastases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dynamic imaging group
Arm Type
Experimental
Arm Description
Dynamic imaging of suspected bone metastases with the investigation drug [68Ga]P15-041
Arm Title
Whole body dosimetry group
Arm Type
Experimental
Arm Description
Determination of human dosimetry of the investigation drug [68Ga]P15-041
Intervention Type
Drug
Intervention Name(s)
[68Ga]P15-041
Intervention Description
Imaging by Positron Emission Tomography after injection of [68Ga]P15-041
Primary Outcome Measure Information:
Title
Time course of uptake of [68Ga]P15-041 in bone metastases
Description
kinetics of [68Ga]P15-041 uptake in known or suspected bone metastases in prostate cancer
Time Frame
60 minutes post injection
Title
Time course of whole body distribution of [68Ga]P15-041
Description
whole body distribution of [68Ga]P15-041 used for human dosimetry determination
Time Frame
3 hours post injection
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041
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