Assessing Pulmonary Changes in Hematopoietic Stem-Cell Transplantation Patients and Patients With Rare-Lung Diseases Using Hyperpolarized Xe MR Lung Imaging
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Xe Gas-Exchange MRI
研究概览
简要总结
This will be an un-blinded, open-label study of children and adults, including those who are being evaluated for or who have undergone HSCT, those with existing respiratory conditions and/or diagnosed gas-exchange impairment, and healthy control volunteers. The participants will be male or female between 3-17 years old (children) and adults age 18 and older.
The study objective is to:
- To optimize the acquisition of images reflecting the "dissolved-phase" Xe distribution in the pulmonary tissues and blood (Xe gas-exchange MRI).
- To develop and test Xe MRI acquisition strategies that separately image alveolar airspace distribution (ventilation), as well as Xe dissolved in pulmonary tissues versus red blood cells (RBCs).
- To acquire images of Xe ventilation and dissolved-phase Xe regional distribution in the enrolled participants.
- To understand the same-day variability of Xe MRI techniques.
- To determine the relationship between Xe MRI and clinical measures such as pulmonary-function-test (PFT) parameters or other biological biomarkers.
- To develop and optimize strategies for Xe MRI in young children including those who are unable to follow the inhalation and breath-hold instructions typical of the Xe MRI procedure.
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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 3 years and older
排除标准
- •Pregnancy or positive pregnancy test
- •Baseline oximetry at MRI visit of less than 90% on room air or less than 90% on a previously prescribed dosage of oxygen delivered by nasal cannula. In some cases of cardiorespiratory disease, if the participant is referred to this research study by their treating physician and considered stable for imaging, the cardiorespiratory criteria will be 5% of their clinical baseline. This should be documented in the research record upon referral of a participant that meets this scenario.
- •Any condition in the opinion of the investigator that would make the participant unable to tolerate the MRI procedure (e.g., neurocognitive delay, behavioral issues).
- •Standard MRI exclusions (e.g., metal, incompatible implants).
研究组 & 干预措施
Hyperpolarized 129 Xenon
Hyperpolarized xenon gas will be administered in doses of up to 1/6TLC (based on either ATS calculations that utilize gender and height to determine the dose or plethysmography data) for participants under 18 years old and 1000 milliliters for adults per our previous research experience followed by a breath hold of up to 16 seconds
干预措施: Hyperpolarized 129 Xenon (Drug)
结局指标
主要结局
Xe Gas-Exchange MRI
时间窗: Through study completion, an average of 5 years
Images reflecting dissolved-phase xenon distribution in pulmonary tissues and blood obtained by xenon MRI
次要结局
- Establish Aquisition Strategies for Xenon Ventilation Imaging(Through study completion, an average of 5 years)
- Percentage difference between Xe MRIs repeated within the same-day(Through study completion, an average of 5 years)
- Correlation between FEV1 and FEV1/FVC from spirometry with ventilation-defect percentage from Xe MRI.(Through study completion, an average of 5 years)