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临床试验/NCT02154568
NCT02154568已完成不适用

Flow Quantification in the Human Airways Using Hyperpolarized Helium 3 MRI

University of Virginia2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年11月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Hyperpolarized helium MRI flow velocity map

研究概览

简要总结

Computer simulations are being developed to predict air flow abnormalities in the airways of patients with lung disease. The purpose of this study is to obtain actual gas flow measurements in the lungs of healthy patients and patients with lung disease and use these measurements to validate the computer models.

详细描述

The Biotechnology High Performance Computing Software Applications Institute (BHSAI) of the Department of Defense (DoD) is studying airflow in the lungs using computational fluid dynamics in order to characterize disease-specific airflow patterns and provide useful information for medical applications. To validate these models, they are seeking to obtain experimental data of airflow in human lungs, both healthy and diseased. An assessment of airflow can be obtained by using hyperpolarized noble gas (HNG) magnetic resonance imaging (MRI) or, more specifically, hyperpolarized helium-3 (HHe) MRI in conjunction with flow-encoding schemes that are well-established in conventional proton MRI

Four chronic obstructive pulmonary disease (COPD) patients and four healthy subjects will undergo pulmonary function tests (PFTs), computed tomography (CT) scan covering the mouth, neck, and chest, and hyperpolarized helium 3 MRI. Before and after the MRI scans, three spirometry readings will be taken while the subject is lying in the same position as in the MR scanners. Data will be analyzed by the BHSAI. UVa will provide the de-identified raw image data and the de-identified results of the spirometry and other tests to BHSAI

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

入选标准

  • Healthy subjects:
  • Normal PFT values: FEV1 > 90% predicted; and Forced vital capacity (FVC) > 90% predicted
  • Normal chest x-ray (CXR)
  • Medical history: No active pulmonary symptoms (cough, shortness of breath, sputum); Negative history of pulmonary disease; Negative smoking history (never smoked)
  • Pulmonary Disease Subjects:
  • PFT values: FEV1/FVC < 70% (indicative of obstruction); and 30% < FEV1 < 50% predicted
  • CXR normal except hyperinflation
  • Symptoms - chronic shortness of breath
  • All test subjects, healthy and with COPD should have similar physical anthropometric characteristics:
  • Similar age with age difference less than 3 years
  • Similar height (within 3-4 inches)

排除标准

  • Any condition for which a MRI procedure is contraindicated.
  • Presence of any non-MRI compatible metallic material in the body, such as pacemakers, metallic clips, etc.
  • Likelihood of claustrophobia
  • Chest circumference greater than that of the helium MR coil.
  • Pregnancy, by report of subject. Clinically in the Department of radiology at UVA, self report is used when screening patients for MR scans as well as CT scans and fluoroscopy studies. If the subject reports there is any chance of their being pregnant a urine pregnancy test will be performed prior to any imaging.

研究组 & 干预措施

Hyperpolarized helium MRI of the chest

Experimental

The purpose of this study is to look at the airflow in the lungs of healthy subjects and subjects with lung disease using Magnetic Resonance Imaging (MRI) with inhaled hyperpolarized helium-3 gas.

干预措施: hyperpolarized helium-3 gas with MRI of the chest (Drug)

结局指标

主要结局

Hyperpolarized helium MRI flow velocity map

时间窗: Day 1

Using hyperpolarized helium as an inhaled contrast agent for MRI, we will measure the velocity of inhaled breath in the trachea.

次要结局

  • Hyperpolarized helium-3 MRI flow velocity map(Day 1)
  • Hyperpolarized helium MRI flow velocity map(Day1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Y. Michael Shim, MD

Associate Professor

University of Virginia

研究点 (2)

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