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

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

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Key information

Conditions

Prostate Cancer Bone Metastases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[68Ga]P15-041

Drug

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

Primary outcomes

Time course of uptake of [68Ga]P15-041 in bone metastases

Time frame: 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

Time frame: 3 hours post injection

whole body distribution of [68Ga]P15-041 used for human dosimetry determination

Sponsors and collaborators

Lead sponsor

Five Eleven Pharma, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2022
Study completion: 2022
First posted: Jul 11, 2016
Registry last updated: Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed