2024-515781-13-00招募中2 期
Benefit of positons emission tomography / 68Gallium citrate tomodensitometry for artificial hip and knee chronic infection diagnosis
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy setting's assessment of the 68Ga citrate PET/TDM for chronic infection diagnosis of artificial hip or knee (sensibility, specificity, predictive positive and negative value).
研究概览
简要总结
Estimation of diagnostic accuracy of 68Ga citrate PET / CT in the diagnosis of chronic hip or knee joint prosthesis infection
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- 68ga-citrate Pet/ct
- 盲法
- Single (Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 18 years old
- •Patient adressed for the first time to reference center for joint prosthesis infection (CRIOA, infectious diseases unit and orthopedic surgery unit) for suspicion of first episode of artificial hip or knee infection
- •Suspicion of artificial joint infection starting at least one month before evaluation.
- •Patient for who routine diagnosis includes screaning by both bone scintigraphy and polynuclear scintigraphy.
- •Patient with positive bone scintigraphy
- •Being affiliated to a health insurance system
- •Having signed an informed consent form (later than the day of inclusion and before any examination required by the research)
排除标准
- •Patient with progressive cancer
- •Patient with negative bone scintigraphy
- •Patient who cannot stop antibiotic for 14 days because of his state of health
- •Pregnant or breastfeeding women
- •Women of childbearing age but not using effective means of contraception
- •Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
- •Subject in relative exclusion period from another protocol
- •Known contraindications to PET exam with radio tracer injection (hypersensitivity to radiopharmaceutical and/or to excipients)
结局指标
主要结局
Diagnostic accuracy setting's assessment of the 68Ga citrate PET/TDM for chronic infection diagnosis of artificial hip or knee (sensibility, specificity, predictive positive and negative value).
Diagnostic accuracy setting's assessment of the 68Ga citrate PET/TDM for chronic infection diagnosis of artificial hip or knee (sensibility, specificity, predictive positive and negative value).
次要结局
- Reproducibility inter- observers of 68Ga citrate PET/TDM interpretation
- Diagnostic accuracy setting's assessment of marked polynuclear scintigraphy
- Diagnosis accuracy's assessment of 68Ga citrate PET/TDM and marked polynuclear scintigraphy for both under-populations: artificial knee or hip infection
- Comparison of diagnostic accuracy setting of 68Ga citrate PET/TDM and marked polynuclear scintigraphy.
- Kind of discrepancy between the two exams
研究者
Principal Investigator
Scientific
Centre Hospitalier Universitaire De Bordeaux
研究点 (1)
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