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Assessing Pulmonary Changes in HSCT

2026年9月10日 更新者：Children's Hospital Medical Center, Cincinnati

Assessing Pulmonary Changes in Hematopoietic Stem-Cell Transplantation Patients and Patients With Rare-Lung Diseases Using Hyperpolarized Xe MR Lung Imaging

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

550

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Ohio
      • Cincinnati、Ohio、美国、45229
        • 招聘中
        • Cincinnati Children's Hospital Medical Center
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Ages 3 years and older

Exclusion Criteria:

  • 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).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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
药品：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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Xe Gas-Exchange MRI
大体时间：Through study completion, an average of 5 years
Images reflecting dissolved-phase xenon distribution in pulmonary tissues and blood obtained by xenon MRI
Through study completion, an average of 5 years

次要结果测量

结果测量
措施说明
大体时间
Establish Aquisition Strategies for Xenon Ventilation Imaging
大体时间：Through study completion, an average of 5 years
Ventilation defect percentage (i.e., hypoventilated lung volume) will be analyzed following the xenon MRI
Through study completion, an average of 5 years
Percentage difference between Xe MRIs repeated within the same-day
大体时间：Through study completion, an average of 5 years
Quantitative outcomes from Xe MRI scans, like the ventilation defect percentage (i.e., hypoventilated lung volume), from within the same participant will be compared using paired statistical tests to assess the same-day repeatability.
Through study completion, an average of 5 years
Correlation between FEV1 and FEV1/FVC from spirometry with ventilation-defect percentage from Xe MRI.
大体时间：Through study completion, an average of 5 years
The correlation between FEV1 and FEV1/FVC measured in liters and/or percent predicted from reference equations and the VDP (ventilation defect percentage) from Xe MRI will be determined.
Through study completion, an average of 5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Children's Hospital Medical Center, Cincinnati

调查人员

  • 首席研究员：Laura Walkup, PhD、Children's Hospital Medical Center, Cincinnati

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年7月24日

初级完成 (估计的)

2029年7月1日

研究完成 (估计的)

2029年7月1日

研究注册日期

首次提交

2025年9月26日

首先提交符合 QC 标准的

2026年9月10日

首次发布 (实际的)

2026年9月16日

研究记录更新

最后更新发布 (实际的)

2026年9月16日

上次提交的符合 QC 标准的更新

2026年9月10日

最后验证

2025年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2023-0678

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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