A Feasibility Study to Determine PET/CT Imaging of Blood Flow to the Bone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Measure of Blood Flow to the proximal femur
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Subjects undergoing PET/CT scans must not be breast-feeding.
- •History of hypersensitivity to fluoride
研究组 & 干预措施
PET/CT scanning with sodium fluoride
Subjects will received PET/CT scanning with sodium fluoride
干预措施: PET/CT Scan (Device)
结局指标
主要结局
Measure of Blood Flow to the proximal femur
时间窗: Within a week of the scan
Measure the sodium fluoride -18 concentration to blood vessels of the the proximal femur
次要结局
未报告次要终点