Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041

Prostate Cancer Clinical Trial

Official title:

A Preliminary Evaluation of Uptake in Bone Metastases, Biodistribution and Excretion of the Novel Radiotracer [68Ga]P15-041 by PET/CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02826382
• Other study ID #: 511-0001-A
• Status: Completed
• Phase: Early Phase 1
• Start date: September 20, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Five Eleven Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase1 study to demonstrate [68Ga]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Neoplasm Metastasis
• Prostate Cancer

Intervention

Drug:
• [68Ga]P15-041
Imaging by Positron Emission Tomography after injection of [68Ga]P15-041

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Five Eleven Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	60 minutes post injection
Primary	Time course of whole body distribution of [68Ga]P15-041	whole body distribution of [68Ga]P15-041 used for human dosimetry determination	3 hours post injection