Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Patients Presenting With Pain in a Prosthetic Knee or Hip Joint
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 20
- 主要终点
- Estimate the Sensitivity and Specificity of [124I]FIAU
研究概览
简要总结
This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic imaging agent for the detection of prosthetic joint infections in patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Males or females age >18 years
- •Ability to provide informed consent
- •A plain anterior-posterior (AP) and frog leg lateral X-ray of the hip or knee within 6 weeks of enrollment
- •Need for operative intervention in the opinion of the surgeon to correct the pain in the prosthetic joint
- •Prosthetic joint implant that has been in site for more than 3 months prior to enrolment
- •Having adequate general health to be expected to tolerate surgery adn to survive for 6 months from the time of informed consent
- •Women must be either postmenopausal or surgically sterile
- •Ability to return for all study assessments
- •Clinically euthyroid, or on stable thyroid replacement therapy
排除标准
- •Subjects who are unable to comply with study requirements
- •Indication, in the opinion of the principal investigator, for urgent surgery that would preclude the time needed for PET-CT scanning
- •History of an inherited mitochondrial disorder (e.g., Leber's hereditary neuropathy; neuropathy; ataxia, retinitis pigmentosa and ptosis [NARP]; myoneurogenic gastrointestinal encephalopathy [MNGIE]; myocolonic epilepsy with ragged red fibers [MERFF]; and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome [MELAS])
- •Alanine aminotransferase (ALT) >5x the upper limit of normal (ULN) OR aspartate aminotransferase (AST) >5X ULN
- •Creatinine clearance <30 mL/min
- •Body mass that exceeds the rating of the CT table
- •Hypersensitivity to iodine
- •Any condition that would put the subject at reasonable risk in the opinion of the investigator
结局指标
主要结局
Estimate the Sensitivity and Specificity of [124I]FIAU
时间窗: 30 hours
The sensitivity and specificity of \[124I\]FIAU in the detection of prosthetic joint infection was determined based on the correlation of the patient's infection status determined by an independent image reviewer and the infection status assessed by an adjudication committee. * Presence or absence of infection: Images were to be assessed and optimized on an ongoing basis. The single blinded reader was to assess independently the PET-CT images (attenuation corrected \[AC\] and non-AC PET plus the AC CT) and provide a diagnosis (infected or uninfected) using the chosen parameter(s) without knowing the results of the surgery. The radiology reviewer was not given any additional clinical information on the patient for reassessments relative to the initial reads. A separate central radiologist was to read the comparator X-rays independently for the presence or absence of infection. All pathology slides were to be read by a single pathologist. Local microbiology results were to be used.
次要结局
- Understand the Prevalence of Prosthetic Joint Infection(30 +/- 2 days)
- Evaluate the Safety and Tolerability of [124I]FIAU(30 +/- 2 days)
- Define PET-CT Interpretation Criteria That Best Differentiate Infected vs Non-infected Prosthetic Joints(30 +/- 2 days)