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临床试验/NCT02478255
NCT02478255已完成2 期

Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment

Bastiaan Driehuys1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2016年3月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Change in Pulmonary Function, as Measured by Ventilation Defect Percentage (VDP)

研究概览

简要总结

The purpose of this study is to determine whether magnetic resonance imaging (MRI) using inhaled hyper polarized xenon-129 (129Xe) gas, and conventional contrast can help visualize impaired lung function and detect changes over time in patients receiving treatment as well as those who don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be able to show areas of abnormal thickening of parts of the lungs. These images combined with images taken with injected contrast agents or other special types of MRI such as conventional proton (1H) MRI may provide a better way to look at lung structure and function. The ultimate goal is to predict the degree of radiation-induced lung injury that will develop in a given patient for a given treatment plan. The investigators anticipate that these images will provide more specific information about lung disease than standard lung function tests. The use of 129Xe MRI is investigational. Investigational means that these tests have not yet been approved by the US Food and Drug Administration and are only available in research studies like this one. In addition, standard MRI with contrast is not typically done as standard of care for monitoring changes due to thoracic radiation therapy, therefore, its use in this study is also considered investigational.

Healthy volunteers are being asked to participate in this study because to develop a database of functional images that are representative of healthy lungs.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Healthy volunteers

Active Comparator

干预措施: Hyperpolarized 129-Xenon gas (Drug)

Patients scheduled to undergo Radiation Therapy (RT)

Active Comparator

Patients scheduled to undergo Radiation Therapy (RT) for lung cancer, or other malignancies such as breast cancer or lymphoma that involve significant irradiation of the thoracic cavity.

干预措施: Hyperpolarized 129-Xenon gas (Drug)

Patients scheduled to undergo Radiation Therapy (RT)

Active Comparator

Patients scheduled to undergo Radiation Therapy (RT) for lung cancer, or other malignancies such as breast cancer or lymphoma that involve significant irradiation of the thoracic cavity.

干预措施: MRI (Device)

Healthy volunteers

Active Comparator

干预措施: MRI (Device)

结局指标

主要结局

Change in Pulmonary Function, as Measured by Ventilation Defect Percentage (VDP)

时间窗: Baseline, following radiation treatment (up to 3 months)

"Ventilation" is defined as the regional 129Xe airspace signal divided by the top 1% of 129Xe airspace signal (representing open-airway ventilation). A "Ventilation Defect" is defined as any region of lung where the Ventilation signal is more than 2 standard deviations below the mean Ventilation signal of healthy volunteer subjects' lungs. "Ventilation Defect Percentage", or VDP, is defined as the volume of a subject's Ventilation Defects divided by the volume of the subject's lung, multiplied by 100%.

次要结局

  • RBC (Red Blood Cell) to Barrier Ratio Following RT(Baseline, following RT (up to 3 months))
  • Change in Gas Exchange Defect Percentage (EDP) Following RT (Radiation Treatment)(Baseline, following RT (up to 3 months))
  • Change in High Barrier Uptake Percentage (HBUP) Following RT(Baseline, following RT (up to 3 months))

研究者

发起方
Bastiaan Driehuys
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bastiaan Driehuys

Associate Professor of Radiology

Duke University

研究点 (1)

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