Novel Gallium 68 Citrate in Orthopedic Infections
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- 68Gallium-citrate and 18F-FDG uptake (SUV) surrounding the femoral and acetabular components of the prosthesis
研究概览
简要总结
In the proposed study, our aim is to evaluate the uptake of 68Gallium-citrate in patients with failed joint prosthesis and compare it with that of conventional 18fluorine-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) scan. We will perform PET/CT scan with 68Gallium citrate and 18F-FDG in subjects with failed hip or knee prosthesis. Both 68Gallium-citrate and 18F-FDG scans, done within 24-48 hours from each other, will be performed within 4 weeks before surgical evaluation/revision of the hardware.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 6 months after hip replacement with complaint of joint pain.
- •Radiographic studies compatible with prosthesis loosening (i.e. periprosthetic infection or aseptic loosening).
- •Pending surgical evaluation and tissue sampling within the next few weeks to differentiate between infection and aseptic loosening.
排除标准
- •Inability to consent
- •Pregnancy or known or suspected hypersensitivity to metals or gallium
- •Joint replacement for any reason other than primary or secondary osteoarthritis
- •Prior surgical therapy for prosthesis failure after initial hospital discharge
- •Active inflammatory/infectious process at any location other than prosthetic joint (Sarcoidosis, Rheumatoid arthritis, HIV infection, SLE)
研究组 & 干预措施
68Gallium-citrate
This arm, undergoing the "68-Gallium citrate PET/CT scan intervention", includes the PET/CT scans performed with 68Gallium-citrate radiotracer. Note that same patients scanned with different radiotracers serve in both arms.
干预措施: 68-Gallium citrate PET/CT scan (Drug)
18F-FDG
This arm, undergoing the "18F FDG PET/CT scan intervention", includes the PET/CT scans performed with 18F-FDG tracer.
Note that same patients scanned with different radiotracers serve in both arms.
干预措施: 18F FDG PET/CT scan (Drug)
结局指标
主要结局
68Gallium-citrate and 18F-FDG uptake (SUV) surrounding the femoral and acetabular components of the prosthesis
时间窗: 1 year
The radiotracer uptake in SUV units is measured in different Gruen zones around the prosthesis and normalized by that of the liver. The values of the two scans will be compared against each other for all patients.
次要结局
- Sensitivity, specificity, and accuracy of 68Gallium-citrate and 18F-FDG scans, by using surgical pathology results as the gold standard.(1 year)
研究者
Nasrin Ghesani
Associate Professor
Icahn School of Medicine at Mount Sinai