A Feasibility Study to Determine PET/CT Imaging of Blood Flow to the Bone (PETCT)

May 28, 2019 updated by: University of California, Davis
To evaluate if a commonly used medical bone scan, called positron emission tomography/computed tomography (PET/CT) with sodium fluoride can measure bone blood flow to the hip.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this research is to validate technique on a commonly used medical bone scan, called positron emission tomography/computed tomography (PET/CT) along with sodium fluoride as the tracer for determining blood flow to the bone. Up to 12 subjects will have PET/CT scans so that we can determine the repeatability and reliability of the images prior to using PET/CT for this use on subjects in the Phase 1b part of Dr. Nancy Lane's clinical research study entitled "A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate in Adult Men and Women with Osteopenia Secondary to Glucocorticoids" (IRB Protocol #866350).

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis

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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects must meet all of the following criteria to be included in the study.

  1. 20 - 75 years old
  2. Must be ambulatory and able to attend all appointments

  3. Women must agree to use one of the following methods of birth control for the duration of the clinical trial:

    systemic hormonal contraceptive (oral, injected, transdermal), intrauterine device, double barrier (e.g., cervical cap or diaphragm with condom or spermicide). Men with female partners must agree to use double barrier contraception, unless their partner is using systemic hormonal contraceptives or has an intrauterine device

  4. Subject undergoing PET/CT scans must have the ability to lay motionless for up to 30 minutes.

Exclusion Criteria:

  1. Subjects undergoing PET/CT scans must not be breast-feeding.
  2. History of hypersensitivity to fluoride

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: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET/CT scanning with sodium fluoride
Subjects will received PET/CT scanning with sodium fluoride
Device: PET/CT Scan
PET/CT scanning with sodium fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of Blood Flow to the proximal femur
Time Frame: Within a week of the scan
Measure the sodium fluoride -18 concentration to blood vessels of the the proximal femur
Within a week of the scan

Collaborators and Investigators

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

Sponsor

University of California, Davis

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)

June 11, 2018

Primary Completion (Actual)

March 25, 2019

Study Completion (Actual)

March 25, 2019

Study Registration Dates

First Submitted

June 5, 2018

First Submitted That Met QC Criteria

June 5, 2018

First Posted (Actual)

June 15, 2018

Study Record Updates

Last Update Posted (Actual)

May 30, 2019

Last Update Submitted That Met QC Criteria

May 28, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 1227928

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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