跳至主要内容
临床试验/NCT02163681
NCT02163681已完成不适用

MRI as a Means to Measure Lung Function: Non-Invasive Imaging in Neonates and Young Children

University of Virginia1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2011年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Ventilation Defects as Seen on Hyperpolarized Helium-3 MRI

研究概览

简要总结

The purpose of this study is to develop rapid MRI techniques for imaging the lung with hyperpolarized helium-3 gas as an inhaled contrast agent. These techniques will be piloted in adults and older children before testing them in younger children and infants. The purpose is to enable imaging of non-sedated infants by imaging so fast as to freeze motion.

详细描述

he purpose of this study is to further develop the techniques to permit the imaging of infant lungs with hyperpolarized helium-3 MRI including techniques for acquisition in free breathing infants and infants on a ventilator. We have developed fast imaging techniques and obtained proof-of-concept data in infants as young as 2 months old. Many pediatric lung diseases including CF, bronchopulmonary dysplasia (BPD) and asthma have their origins in infancy so it would be desirable to be able to image infants with hyperpolarized gas MRI. We focused on developing fast imaging techniques to, in essence, freeze lung motion in non-sedated infants. We feel the technique will be more widely adopted if clinically useful images can be obtained without sedating the infant. Some very rapid imaging techniques have been developed for conventional proton MRI for applications such as cardiac MRI that require very short acquisition time. We modified these techniques for use in hyperpolarized gas MRI and developed a technique that permits the acquisition of the entire lung volume of an infant in less than 1 second. These techniques would also be useful for imaging infants who are still on a ventilator with the hope of increasing our understanding of lung development and neonatal lung disease.

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
4 Months 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • MRI sequence development (n=40): Healthy subjects and patients with CF, BPD, or asthma will be used in the development of the rapid imaging techniques. These subjects will be age 4 months to 65 years old. Healthy subjects can have no history of chronic respiratory disease. The subjects with CF or asthma must have a physician diagnosis of their respective disease.
  • Proof-of-Concept Study (n=30): Ten healthy infants,10 infants with CF, and 10 infants with BPD age 4-24 months will be imaged in the proof-of-concept study. Healthy infant must have had an uncomplicated term birth and have no history of chronic respiratory symptoms. The patients with CF must have a physician diagnosis of CF and be at their baseline clinical status on the day of imaging.

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 magnetic resonance (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 3 MRI of the chest

Experimental

Using hyperpolarized helium-3 as an inhaled contrast agent for MRI, we will assess the lung ventilation.

干预措施: Hyperpolarized Helium-3 MRI of the chest (Drug)

结局指标

主要结局

Ventilation Defects as Seen on Hyperpolarized Helium-3 MRI

时间窗: Day 1

On hyperpolarized helium-3 MRI, well ventilated areas of the lung appear bright and poorly ventilated areas appear dark. The poorly ventilated areas are called ventilation defects. Human readers looked at the hyperpolarized helium-3 MR images and determined whether the lungs had: No Defects, Small Defects, or Large Defects.

次要结局

未报告次要终点

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 (1)

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