Early Feasibility Study of Somatostatin Receptors PET Imaging (68Ga-DOTATOC PET/CT) for the Diagnosis of Infective Endocarditis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Detectability of infective endocarditis by 68Ga-DOTATOC PET/CT
研究概览
简要总结
Study hypothesis: 68Ga-DOTATOC PET/CT could detect cardiac foci of infective endocarditis regardless of the type of valve (native or prosthetic) and also extracardiac localizations related to this pathology (infection responsible, peripheral emboli, ...). This study is a proof of concept with low population
详细描述
The incidence of infective endocarditis (IE) in France is estimated to be around 30 cases per million inhabitants in studies conducted in Western countries and is significantly increased in patients with a valve prosthesis and even more so in cases of a history of endocarditis. The morbi-mortality is significant and the hospital mortality rate is 20%.
The diagnosis of IE remains difficult and according to the modified Duke criteria, the diagnostic sensitivity is 80%.
Currently, the diagnosis of IE is often determined according to the 2015 ESC criteria and the sensitivity increases from 57% to 84% regarding IE on prosthetic valves.
The 18F-FDG PET/CT examination is of major interest in the diagnosis of AR on prosthetic valves with a detection sensitivity of between 70 and 90% (with an accuracy of 70 to 80%). Concerning native valves, the sensitivity of PET/CT remains below 50%.
Indeed, a "physiological" myocardial fixation in 18F-FDG PET/CT compromises the interpretation of PET exam, so it is important to start a hypoglucidic-hyperlipidic diet the day before the 18F-FDG PET/CT, followed by a 12-hour fasting period.
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
- •Adult who has received full information about the organisation of the research and has signed informed consent adult
- •Participant hospitalised for definite AE according to modified Duke criteria (Li), on native or prosthetic valve, referred for 18F-FDG PET/CT from Cardiology and Infectious Diseases departments
排除标准
- •Person with a history of hypersensitivity from previous use of 68Ga-DOTATOC
- •Unable to perform a 68Ga-DOTATOC PET scan (agitated, confused patient...).
- •Inability to schedule 68Ga-DOTATOC PET/CT the day after 18F-FDG PET/CT.
- •Person with severe renal impairment (GFR <30 ml/min/1.73 m2)
- •Participant treated with a somatostatin analogue.
- •Participant with Cushing's syndrome
- •Pregnant, potentially pregnant or breastfeeding women
- •Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
- •Person of full age who is unable to give consent
- •Person deprived of liberty by a judicial or administrative decision
- •Person subject to psychiatric care by virtue of Articles L. 3212-1 and L. 3213-1
研究组 & 干预措施
Patients with definite IE will be included and referred for 18F-FDG PET/CT in the study
Fourteen patients with definite IE according to the modified Duke criteria (Li) will be included and referred for 18F-FDG PET/CT in the study. A 68Ga-DOTATOC PET/CT scan will be performed specifically for research at 24 hours.
干预措施: 68Ga-DOTATOC PET/CT (Drug)
结局指标
主要结局
Detectability of infective endocarditis by 68Ga-DOTATOC PET/CT
时间窗: one year
to visually evaluate the detectability of cardiac and extracardiac foci associated with infective endocarditis (IE) on native or prosthetic valve by 68Ga-DOTATOC PET/CT.
次要结局
- To quantify the infective foci uptake of 68Ga-DOTATOC(one year)
- 68Ga-DOTATOC PET/CT and 18F-FDG PET/CT results comparison(one year)
- 68Ga-DOTATOC PET/CT and 18F-FDG PET/CT results comparison of cardiac step(one year)