Evaluation of Positron Emission Tomography in Extrapulmonary Tuberculosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- ΣSUVmax variations between the beginning and end of treatment and during follow-up post-treatment, in patients considered cured
研究概览
简要总结
Tuberculosis (TB) remains a major public health problem. In extra-pulmonary forms, evidence of bacteriological cure is difficult to be obtained raising the need for other therapeutic assessment tools. 18F-Fluoro-deoxy-glucose (FDG) is a glucose analogue widely used in Positron Emission Tomography (PET). Its uptake is high in cancer cells and in inflammatory cells, especially in active TB foci. The hypothesis is a decrease in the uptake of FDG in the foci of TB during treatment permitting a non-invasive monitoring of therapeutic response. The main objective is to describe the evolution under treatment of the FDG uptake in PET imaging in TB foci in patients cured from lymph node and bone TB. Secondary objectives are to compare the decrease of FDG uptake according to type of location, to define the frequency of localizations revealed by FDG-PET and their impact on therapeutic management at the beginning and the end of treatment, and to describe the evolution of PET in patients not cured.
详细描述
Longitudinal observational multicenter pilot study. 55 patients to be included Total duration of the study: 51 months. Inclusion period: 27 months Follow up period: 18 to 24 months Number of participating centers: 11 Average number of inclusion per month per center: 1-2
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
- •Affiliated to a social security system or "AME"
- •Patient informed of the objectives and constraints of the study and giving informed consent
- •Patient can keep lying valid at least 30 minutes
- •Patient not HIV infected or, if infected, with CD4 counts> 200/mm3 for at least 3 months
排除标准
- •Suspicion of other concurrent infection
- •Severe immunosuppression in case of HIV infection
- •Inflammatory disease
- •Pregnant or nursing women
- •Radiation therapy
- •Uncontrolled diabetes
- •Prolonged corticosteroid therapy (> 20mg/day)
- •Patient unable to sustain injected CT scan and MRI
研究组 & 干预措施
Positron Emission Tomography
Positron Emission Tomography
干预措施: Positron Emission Tomography with 18F-Fluoro-deoxy-glucose (Other)
结局指标
主要结局
ΣSUVmax variations between the beginning and end of treatment and during follow-up post-treatment, in patients considered cured
时间窗: 6 to 18 months
To measure FDG uptake and evolution, the ΣSUVmax will be used. SUV ("Standard Uptake Value") is defined as tissue concentration of FDG / administered FDG dose / patient weight. ΣSUVmax is the sum of the maximum SUV measured in every TB foci. ΣSUVmax variations between the beginning and the end of treatment, and 6 months later in cases of persistent uptake at the end of treatment will be studied in patients considered cured
次要结局
- Change in SUVmax differences in the lesions according to their location in cured patients.(6 to 18 months)
- Variations ΣSUVmax and SUVmax in individual lesions in patients not cured.(6 to 18 months)
- Frequency, type and consequences on the therapeutic management of lesions revealed by FDG-PET.(6 to 18 months)