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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Normal Subjects

Intervention / Treatment
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* Device: PET/CT Scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET/CT scanning with sodium fluoride<br>Subjects will received PET/CT scanning with sodium fluoride | Device: PET/CT Scan<br>* PET/CT scanning with sodium fluoride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |