Study of Hyperpolarized Xenon (MagniXene) in Patients With Obstructive Pulmonary Diseases (Asthma and COPD) to Assess Regional Lung Function by Delineating Regions of Abnormal Lung Ventilation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Xemed LLC
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- HXe MRI delineation of regions with abnormal lung ventilation in asthma and COPD patients
研究概览
简要总结
The purpose of this clinical trial is to demonstrate hyperpolarized xenon (HXe) as a medical imaging drug (agent) for Magnetic Resonance Imaging (MRI) of the human lung ventilation.
详细描述
HXe MRI provides a diversity of imaging techniques for interrogating pulmonary function and lung microstructure. The most mature of these techniques utilizes HXe spin-density MRI to depict regional lung ventilation. Prior work suggests that ventilation imaging has utility in all obstructive lung diseases. This is a Phase II clinical trial to assess HXe MRI capability of providing qualitative and quantitative clinical information regarding lung ventilation. Proton and xenon images will be acquired within single breath holds on 28 subjects per year, including healthy volunteers and patients with COPD and asthma. All studies will include repeat scans and Pulmonary Function Tests (PFT). Ventilation scans with Technetium-99m (Tc-99m) diethylene-triamine-pentaacetate (DTPA) aerosol scintigraphy will be acquired on lung patients.
The primary goal of this aim is to validate the effectiveness of HXe ventilation MRI for delineating regions of normal and abnormal lung ventilation. To validate the regional depiction of ventilation, HXe MRI ventilation will be compared with nuclear medicine Tc-99m DTPA ventilation scintigraphy. The comparatively low spatial and temporal resolution of ventilation scintigraphy will limit this study to demonstrating only that HXe MRI ventilation is not inferior to the current clinical standard. Additionally, the concordance between measurements of the whole lung volume from both proton MRI and HXe MRI with PFT, the current clinical standard for lung volume measurement, will be assessed as a secondary outcome of the study.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Baseline oxygen requirement.
- •Blood oxygen saturation of 92% less than as measured by pulse oximetry on the day of imaging.
- •FEV1 percent predicted less than 25%.
- •Pregnancy or lactation.
- •Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded.
- •Chest circumference greater than that of the xenon MR coil.
- •History of congenital cardiac disease, chronic renal failure, or cirrhosis.
- •Inability to understand simple instructions or to hold still for approximately 10 seconds.
- •History of respiratory infection within 2 weeks prior to the MR scan.
- •History of heart attack, stroke and/or poorly controlled hypertension.
- •Known hypersensitivity to albuterol or any of its components, or levalbuterol.
研究组 & 干预措施
HXe MRI lung ventilation
Each subject will inhale a dose of HXe gas (up to one liter HXe) while lying inside an MRI scanner. A high-resolution 3D map of the lung spaces filled with HXe gas will be acquired during a short breath-hold. Additionally, proton MRI of the chest cavity will be recorded during the same breath-hold for registering the lung boundaries. All subjects will undergo Pulmonary Function Tests. Subjects suffering from obstructive lung disease will have Tc-99m DTPA lung scintigraphy performed for comparing with HXe images.
干预措施: HXe MRI lung ventilation (Drug)
结局指标
主要结局
HXe MRI delineation of regions with abnormal lung ventilation in asthma and COPD patients
时间窗: three years
Depiction of ventilation defects with HXe MRI is not worse than presently accepted clinical method, Tc-99m DTPA scintigraphy, as judged by skilled readers and software analysis. The primary outcome variable will be binary: if ventilation is detected the value is 1, the value is 0 otherwise (defect). The level of agreement between HXe MRI and Tc-99m DTPA will be statistically calculated.
次要结局
- Ventilated volume of the lungs determined by HXe MRI(three years)
- Number of ventilation defects in COPD and asthma patients(three years)