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

Normal Subjects Clinical Trial

— PETCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03557450
• Other study ID #: 1227928
• Status: Completed
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: March 25, 2019

Study information

• Verified date: May 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: March 25, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Normal Subjects

Intervention

Device:
• PET/CT Scan
PET/CT scanning with sodium fluoride

Locations

Country	Name	City	State
United States	UC Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Blood Flow to the proximal femur	Measure the sodium fluoride -18 concentration to blood vessels of the the proximal femur	Within a week of the scan