129Xe Gas Exchange Imaging in IPF and cHP: A Reliability Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- RBC:Barrier Ratio
研究概览
简要总结
This research is a study to test the reliability of Hyperpolarized Xenon MRI (HXe MRI) as a biomarker in interstitial lung disease. The study is a non-randomized study to evaluate the test-retest performance of HXe MRI in Idiopathic Pulmonary Fibrosis (IPF) and chronic Hypersensitivity Pneumonitis (cHP) as a non-invasive biomarker of disease severity and prognosis. The study will include approximately 15 subjects with IPF, 15 subjects with cHP and 10 sex and age-matched normal controls performed across 3 sites.
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
- 是
入选标准
- •Adults > 18 years of age
- •Diagnosis of progressive chronic HP, IPF as determined by MDD discussion (historical or during screening period) OR normal control (no history of known lung disease, no abnormal parenchymal or airway findings on CT examination and no values outside of the normal for FVC, FEV1, TLC, and DLCO.)
- •FVC % Predicted >45%
- •DLCO % Predicted >30%
- •Progressive lung disease as defined by one of the following criteria within 24 months of screening visit
- •Relative decline in the FVC ≥ 10% of the predicted value
- •Relative decline in the FVC of ≥ 5% - < 10% of the predicted value and worsening of respiratory symptoms
- •Relative decline in the FVC of ≥ 5% - < 10% of the predicted value and an increased extent of fibrosis on prior clinical high-resolution CT
- •Worsening of respiratory symptoms and an increased extent of fibrosis on high-resolution CT.
排除标准
- •Stable FVC over 2-year period as determined by study physician
- •Unstable cardiac condition within 6 months of screening as determined by study physician
研究组 & 干预措施
Subjects with Progressive Interstitial Lung Disease
Assess the intra-visit reliability and sensitivity to progression of 129Xe MR imaging measurements using a standardized imaging protocol in subjects with IPF and cHP.
干预措施: Hyperpolarized Xe129 (Drug)
结局指标
主要结局
RBC:Barrier Ratio
时间窗: RBC:Barrier will be assessed at Baseline and at 6 months.
RBC:Barrier ratio will be determined using 129 Xenon MRI in 2 successive scans on two separate days 6 months apart. Same-day Repeated measures will be used to assess reliability of RBC:Barrier. Data acquired at 6 months will be correlated with FVC.
次要结局
未报告次要终点