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

January 10, 2023 updated by: Five Eleven Pharma, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60 minutes post injection
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
3 hours post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Five Eleven Pharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2016

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 511-0001-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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