Study of Pulmonary MRI for the Diagnosis of Bronchiolitis Obliterans Syndrome After Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- lung MRI concordance as compared to chest CT-scan
研究概览
简要总结
Bronchiolitis Obliterans Syndrome (BOS) is a major complication of Hematopoietic Stem cell Transplantation (HSCT) occurring in the context of chronic GVHD and associated with a poor prognosis. The diagnosis of BOS is based on functional (Pulmonary Functional Tests) and morphological criteria (chest CT-scan). Early diagnosis of BOS represents an unmet need and would facilitate early therapeutic interventions. Lung MRI has been recently developed with new sequences facilitating morphological and functional lung analysis in various inflammatory contexts. The goal of this study is to compare the morphological performances of chest CT-scan and MRI
详细描述
Patients undergoing allogeneic stem cell transplantation may develop non-infectious respiratory complication related to chronic graft versus host disease and called bronchiolitis obliterans syndrome (BOS). The occurrence of BOS is associated with a decreased survival reaching 13% at 5 years (Dudek et al, BBMT 2003). Thus, screening and diagnosis of BOS appear as a priority of post-transplant patients monitoring, in order to begin early therapy if needed. To this end, patients undergo systematic and regular screening using pulmonary function tests (PFTs). In case of abnormal PFTs, tests are completed the screening of respiratory infections and chest computed tomographic scan (CT-scan) is performed. A report from the National Institute of Health described the following criteria required for the diagnosis of BOS : FEV1/vital capacity < 0.7, FEV1 < 75% or a decline >/= 10% from baseline, residual volume > 120%, absence of documented infection, and the presence of CT-scan signs suggestive of BOS : air trapping by expiratory CT or small airway thickening or bronchiectasis.
BOS severity depends on the development of fibrotic and fixed damages, poorly responding to therapies. New tools are needed in order to favor early BOS diagnosis.
A recent study from our center showed that repeated CT-scans in stem cell transplant patients is associated with increased risk of neoplasia. In addition, recent studies from our center evaluated the use of pulmonary MRI providing good performance without X-ray exposure (Dournes G et al, Radiology 2015 et Dournes G et al, Eur Radiol 2015).
More recently, Renne et al (Radiology 2015) studied the performance of pulmonary MRI coupled with oxygen transfer analysis for the diagnosis of chronic lung allograft dysfunction. This study showed altered imaging parameters in patients developing BOS, including patients with early BOS stage (0p stage).
As pathogenic mechanisms seem to be shared between post-stem cell transplant and post-lung transplant BOS, we hypothesize that pulmonary MRI with oxygen transfer analysis and ultra short echo time may represent a non-invasive, non-irradiating and sensitive research tool for the detection and quantification of pulmonary lesions in patients screened for post-stem cell transplant BOS.
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
- •Patient ≥ 18 yo ;
- •Patient who underwent an allogeneic stem cell transplantation (SCT)
- •> 3 months post-SCT
- •With evidence of
- •respiratory symptoms, and/or
- •Pathological PFTs defined by : obstructive syndrome (FEV1 :vital capacity/CVF < 0.7), FEV1 < 0.75 of pre-SCT values, residual volume > 120%, and/or ;
- •Altered PFTs consistent with 0p stage described in lung transplantation BOS: FEV1 decline ≥ 10 % and/or FEF25-75 decline ≥ 25% compared to pre-SCT PFTs, and/or ;
- •Abnormal chest CT-scan with findings consistent with BOS: evidence of air trapping on expiratory CT-scan, bronchiectasis, and/or airway thickening.
排除标准
- •Contraindication for MRI ;
- •Contraindication of oxygen administration ;
- •Decompensation of altered respiratory function ;
- •Acute respiratory infection (bacterial, fungal or viral) documented in the last 6 weeks ;
研究组 & 干预措施
Lung MRI
lung MRI concordance as compared to chest CT-scan for the description of morphological abnormalities necessary for the diagnosis of BOS after HSCT. It will be evaluated using lung MRI performed after inclusion (D0) using a standardized procedure
干预措施: lung MRI (Device)
结局指标
主要结局
lung MRI concordance as compared to chest CT-scan
时间窗: Baseline
lung MRI concordance as compared to chest CT-scan for the description of morphological abnormalities necessary for the diagnosis of BOS after HSCT. It will be evaluated using lung MRI performed after inclusion (Baseline) using a standardized procedure. The agreement between MRI and chest CT-scan for the presence or absence of the following features, will be measured at the segmental level: airway thickening, bronchiectasis, air trapping.
次要结局
- Residual volume(Baseline)
- total lung capacity(Baseline)
- BOS stages(Baseline)
- Force Expiratory Volume(Baseline)
- inter-observer reproducibility of the Bhalla score in MRI(Baseline)
- oxygen transfer capacity(Baseline)
- Bhalla Score precision in morphological MRI(Baseline)
- FEV1/VC(Baseline)
- intra-observer repeatability of the measure of oxygen transfer capacity(Baseline)
- inter-observer reproducibility of the Bhalla score in CT scan(Baseline)
- Bhalla Score in CT scan(Baseline)
- intra-observer repeatability of the Bhalla score in CT scan(Baseline)
- intra-observer repeatability of the Bhalla score in MRI(Baseline)
- inter-observer reproducibility of the measure of oxygen transfer capacity(Baseline)