Interest of Parametric Positron Emission Computed Tomography Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis : PARAVA Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Determination of diagnostic value of parametric positron emission computed tomography
研究概览
简要总结
The objective of this study is to determine if early parametric positron emission computed tomography is useful to diagnose cardiac prosthetic valve infections.
详细描述
In addition to routine examinations (biological and microbiological tests, transesophageal or transthoracic ultrasound, transesophageal or transthoracic ultrasound, and leukocyte scintigraphy) of a parametric acquisition during the positron emission computed tomography parametric acquisition during positron emission computed tomography , this examination being itself planned in a standard way.
The definitive diagnosis according to the Duke-Li criteria will be established three months later in a multidisciplinary consultation meeting.
The final diagnosis according to the Duke-Li criteria will be made three months later in a multidisciplinary consultation meeting, blinded to the results of the parametric positron emission computed tomography, and with knowledge of the results of the standard positron emission computed tomography and the entire work-up.
Results and all the complementary work-up.
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
- •Age superior to18 years,
- •Effective contraception for women of childbearing age or negative pregnancy test on the day of the exam
- •Good general condition. WHO ≤ 1
- •Suspicion of endocarditis on a prosthetic heart valve implanted more than 3 months ago
- •Labeled polynuclear scintigraphy performed within a maximum of 15 days before positron emission computed tomography
- •Standard positron emission computed tomography planned as part of the extension assessment
- •Informed and signed consent before any specific study procedure.
- •Patient affiliated to the social security system
排除标准
- •Presence of an active cancer in the previous three years
- •Pregnancy or breastfeeding
- •Poorly controlled diabetic patients
- •Protected adults (under guardians or curators)
- •Impossible decubitus (orthopnea, ...),
- •Hypersensitivity to FDG or to one of the excipients of the radiopharmaceutical.
研究组 & 干预措施
Parametric positron emission computed tomography
干预措施: Parametric positron emission computed tomography (Device)
结局指标
主要结局
Determination of diagnostic value of parametric positron emission computed tomography
时间窗: 3 months
area under the curve of the Ki parameter (and the Vd parameter) as a function of the presence of endocarditis diagnosed during the multidisciplinary consultation meeting at 3 months
次要结局
- Correlation between parametric positron emission computed tomography and scintigraphy with labelled leukocytes(3 months)