The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Presence or not of infectious endocarditis on surgical materials
研究概览
简要总结
Infectious endocarditis is a serious pathology with difficult diagnosis especially on prosthetic valves or cardiac device because of the plurality of clinical presentations and the low sensitivity value of echocardiography in these patients. Despite a well validated indication for the detection of septic emboli, the value of FDG-PET for the detection of prosthetic valves or cardiac implantable device is still unclear especially because of frequent non-septic inflammatory processes.
To improve the specificity value, the use of radio-labeled leukocytes scintigraphy is conventionally proposed. An alternative method is to label leukocytes in vivo with an anti-murin anti body fragment ( Sulesomab , Leukoscan®). This scintigraphy is regularly used in the investigation of osteomyelitis and has been proposed in infectious endocarditis. To knowledge of investigators, the value of Leukoscan® scintigraphy on prosthetic valve or cardiac device infection had not been studied.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged > 21 years
- •Patients presenting a suspicions of infectious endocarditis on surgical materials
- •Written informed consent
排除标准
- •Patient with a history of exposure to murine antigens, particularly a patient who has already received a 99mTc-Leukoscan® scintigraphy
- •Patients whose clinical condition requires prompt care, not allowing them to wait for the examination
- •Pregnant or nursing (including pumping for storage and feeding)
- •Patients under adapted antibiotic therapy for more than 15 days
- •Deprivation of civil rights (curatorship, guardianship, safeguard of justice)
研究组 & 干预措施
99mTc-Leukoscan® scintigraphy
Patients presenting a suspicions of infectious endocarditis on surgical materials and undergoing the 99mTc-Leukoscan® scintigraphy
干预措施: 99mTc-Leukoscan® scintigraphy (Drug)
结局指标
主要结局
Presence or not of infectious endocarditis on surgical materials
时间窗: 3 months (plus or minus 1 month)
The presence or not of infectious endocarditis on surgical materials will be measured using Duke's criteria of patients follow-up at 3 months (plus or minus 1 month).
次要结局
未报告次要终点