Trial | NCT02826382  Report issue

Title

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

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    14
A phase1 study to demonstrate [68Ga]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.
Study Started
Sep 20
2016
Primary Completion
Dec 31
2022
Study Completion
Dec 31
2022
Last Update
Jan 12
2023

Drug [68Ga]P15-041

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

Dynamic imaging group Experimental

Dynamic imaging of suspected bone metastases with the investigation drug [68Ga]P15-041

Whole body dosimetry group Experimental

Determination of human dosimetry of the investigation drug [68Ga]P15-041

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
No Results Posted