2024-514331-24-00招募中2 期
Contribution of PET/CT with Gallium 68 citrate (68Ga-PET/CT) for the diagnosis of prosthetic valve infective endocarditis - CiGal-EI-TEP
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sensitivity of 68Ga-PET/CT for the diagnosis of prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve
研究概览
简要总结
Estimation of sensitivity of PET/CT with Gallium 68 citrate (68GaPET/CT) for the diagnosis of prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Experimental: 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
- 是
入选标准
- •Adult patient (over 18 years old)
- •Patient with a prosthetic heart valve
- •Patient suspected of infective endocarditis (on clinical and/or microbiological and/or imaging data)
- •Patient whose history is discussed in the multidisciplinary meeting dedicated to endocarditis
- •Patient beneficiary of a social security scheme
- •Free, informed and written consent signed by the participant and the investigator
排除标准
- •pregnant or breastfeeding women
- •women of childbearing potential not using effective contraception
- •patients referred to in articles L.1121-5 to L.1121-8 (persons deprived of liberty by judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent)
- •Patient with cardiac surgery within 2 months of inclusion
- •Subject in a period of relative exclusion due to another protocol
- •Known contraindication to PET/CT with injection of radiotracers (hypersensitivity to radiopharmaceuticals and/or excipients)
结局指标
主要结局
Sensitivity of 68Ga-PET/CT for the diagnosis of prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve
Sensitivity of 68Ga-PET/CT for the diagnosis of prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve
次要结局
- Specificity, positive and negative predictive values of 68Ga-PET/CT for the diagnosis of infective endocarditis on prosthetic valve in patients suspected of infective endocarditis on prosthetic valve
- Cohen's kappa for inter-observer reproducibility of 68Ga-PET/CT for the diagnosis of infective endocarditis on prosthetic valve in patients suspected of infective endocarditis on prosthetic valve
- Sensitivity, specificity and positive and negative predictive values of 18FDG-PET/CT for the diagnosis of infective endocarditis on prosthetic valve
- Discrepancies between 68Ga-PET/CT and 18FDG-PET/CT for the evaluation of the spread of infection assessment and the search for the initial portal of pathogen entry
研究者
Coordinating Investigator
Scientific
Centre Hospitalier Universitaire De Bordeaux
研究点 (1)
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