A Feasibility Study to Determine PET/CT Imaging of Blood Flow to the Bone
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 20 - 75 |
Updated: | 6/29/2018 |
Start Date: | June 11, 2018 |
End Date: | May 15, 2019 |
Contact: | Nancy E Lane, MD |
Email: | nelane@ucdavis.edu |
Phone: | 916-734-0758 |
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.
tomography/computed tomography (PET/CT) with sodium fluoride can measure bone blood flow to
the hip.
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).
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).
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
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