EVALUATION OF THE DIAGNOSTIC VALUE OF PET (18F-FDG) IN CHRONIC GRAFT VERSUS HOST DISEASE (cGVH)
试验速览
- 阶段
- 不适用
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Measure of sensibility and specificity of PET (18F-FDG) for cGVH diagnosis in comparison to standard care
研究概览
简要总结
Allogeneic stem cell transplantation was developed to cure many patients with hematological malignancies. It results in the development of graft versus host disease (GVHD) in 30-70% of cases. Chronic GVHD diagnosis currently uses biopsies of affected organs (skin, liver, gastrointestinal tract) and / or the observation of typical clinical signs sufficient for diagnosis. However, the anatomical sites for biopsy including the digestive tract are not clearly identified (high or low biopsy) and may present risks in their realization in particular in patients weakened by blood disease or immunosuppression.
PET-CT with 18F-FDG has already been evaluated in chronic inflammatory diseases such as Crohns disease with good sensitivity and specificity. It interest in the graft against the host was studied in acute forms of digestive and allows lesion mapping and monitoring the effectiveness of treatment.
Among patients with chronic GVHD scleroderma form, PET with 18F-FDG enabled to view musculoskeletal uptakes localized to the affected areas identified with MRI.
The investigators propose a study evaluating the sensitivity and specificity of the examination by PET-CT with 18F-FDG in the diagnosis of chronic GVHD compared to conventional diagnostic tools.
详细描述
Patients will have PET/CT at day 150+/-15d post-hematopoietic stem cell transplantation (HSCT)
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 >18 years
- •Signed informed consent
- •subject covered by a social security system
- •Absence of contraindication to PET (18F-FDG)
- •Allogeneic stem cell transplantation
排除标准
- •Adult patient under tutelage.
- •Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception
- •Age<18 years
- •Evolutive infectious disease
- •glycemia >10mmol/L
结局指标
主要结局
Measure of sensibility and specificity of PET (18F-FDG) for cGVH diagnosis in comparison to standard care
时间窗: 5 months
Presence of pathological 18-FDG uptakes on PET-CT examination in allografted patient compared with standard tests (clinical examination score GVHD, as defined by the NI (with or without targeted organ biopsy) Patient with negative PET-CT and without GVHD signs (NIH classification according to Filipovitch et al) are considered as true negative. Patient with positive PET-CT without GVHD signs are considered as false positive. Patient with clinical GVHD and negative PET-CT are considered as falsse negative and patients with clinical GVHD and positive PET-CT are true positive. The follow-up will determine if PET-CT is positive before the onset of clinical signs of GVHD.
次要结局
未报告次要终点