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Completed

NCT Number: NCT03557450

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

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.

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Key information

Conditions

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis

Sacramento, California, 95817, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

  • 20 - 75 years old
  • Must be ambulatory and able to attend all appointments
  • 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

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

Exclusion criteria

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

Treatment and study plan

PET/CT Scan

Device

PET/CT scanning with sodium fluoride

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Acronym: PETCT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 15, 2018
Registry last updated
May 30, 2019

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.

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