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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03557450

Acronym

PETCT

Enrollment

Registered

2018-06-15

Start date

2018-06-11

Completion date

2019-03-25

Last updated

2019-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Subjects

Brief 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.

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).

Interventions

DEVICEPET/CT Scan

PET/CT scanning with sodium fluoride

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026