Harmonized Hyperpolarized 129Xe MRI for Noninvasive Assessment of Pulmonary Hypertension in Interstitial Lung Disease and Systemic Sclerosis (ILD-PH/SSc)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 51
- 主要终点
- Diagnostic Accuracy for Detection of Pulmonary Hypertension (sensitivity)
研究概览
简要总结
This study aims to evaluate a noninvasive magnetic resonance imaging technique using hyperpolarized xenon gas to measure lung function in adults with interstitial lung disease, pulmonary hypertension, and systemic sclerosis. Researchers will assess whether MRI measurements correlate with clinical measures of lung and vascular function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Age ≥18 years at enrollment.
- •Participant is willing and able to provide written informed consent.
- •Able (in the Investigator's opinion) and willing to comply with all study requirements.
- •Participant has or is suspected to have one of the following pulmonary conditions:
- •Healthy volunteers: aged 18-30 years; no known cardiopulmonary disease; has not smoked tobacco products in the previous 5 years; smoking history, if any, is less than or equal to 5 pack-years; no history of using other inhaled products more than 1 time per week for > 1 year OR
- •ILD-PH: ≥18 years; ILD diagnosis; precapillary PH by RHC (mPAP >20 mmHg, PVR >2 WU, PCWP ≤15 mmHg) within the specified window OR
- •SSc: systemic sclerosis diagnosis with or without PH
排除标准
- •Any condition which, in the opinion of the Investigator, would make it unsafe or unsuitable for the participants to undergo MRI (for example: presence of an implanted or external MRI unsafe device that cannot be removed, body weight exceeding table limitations, inability to lie flat, or severe claustrophobia).
- •Inability to hold breath for 10-15 seconds for required imaging or for completion of DLCO measurements.
- •Active pulmonary infection or lung cancer.
- •Recent respiratory infection or pulmonary disease exacerbation within 4 weeks of screening.
- •Participants who are known to be pregnant or lactating.
- •Concurrent enrollment and participation in a study which, in the opinion of the Investigator, would interfere with the study compliance, or outcome assessments or would prohibit the collection of the required data points.
研究组 & 干预措施
Hyperpolarized Xenon MRI
Participants undergo hyperpolarized Xenon MRI imaging and clinical assessments.
干预措施: Hyperpolarized 129 Xenon Gas (Drug)
结局指标
主要结局
Diagnostic Accuracy for Detection of Pulmonary Hypertension (sensitivity)
时间窗: Single study visit, Day 1
Sensitivity of pre-specified 129Xe MRI biomarkers for identifying pre-capillary pulmonary hypertension in participants with systemic sclerosis, using right-heart catheterization as the reference standard.
Diagnostic Accuracy for Detection of Pulmonary Hypertension (specificity)
时间窗: Single study visit, Day 1
Specificity of pre-specified 129Xe MRI biomarkers for identifying pre-capillary pulmonary hypertension in participants with systemic sclerosis, using right-heart catheterization as the reference standard.
次要结局
- RBC Oscillation Imaging Amplitude Defect Percentage(Single study visit, Day 1)
- Whole-Lung RBC Chemical Shift(Single study visit, Day 1)
研究者
Bastiaan Driehuys
Associate Professor of Radiology
Duke University