ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02826382
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Five Eleven Pharma, Inc.

Brief Summary:
A phase 0 study to demonstrate [68Ga]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.

Condition or disease Intervention/treatment Phase
Prostate Cancer Bone Metastases Drug: [68Ga]P15-041 Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Preliminary Evaluation of Uptake in Bone Metastases, Biodistribution and Excretion of the Novel Radiotracer [68Ga]P15-041 by PET/CT
Actual Study Start Date : September 20, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826382


Contacts
Contact: Matthew Fillare Matthew.Fillare@uphs.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States
Contact: Matthew Fillare       Matthew.Fillare@uphs.upenn.edu   
Sponsors and Collaborators
Five Eleven Pharma, Inc.

Responsible Party: Five Eleven Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02826382     History of Changes
Other Study ID Numbers: 511-0001-A
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases