Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Hyperpolarized Helium-3 MR Images
研究概览
简要总结
The purpose of this study is to test the efficacy of Hyperpolarized Helium-3 gas in MR imaging in COPD, asthmatics, CF and healthy volunteers.
详细描述
Current pulmonary imaging techniques are clinically regulated to machines that produce radiation. MR which does not produce radiation was not possible due to the low concentration of fluids in the open spaces of the lungs. With hyperpolarized noble gases we can now use the safe techniques of MR imaging to view the airways of the lungs, thus limiting human exposure to radiation. This technique has already been proven to be possible in human subjects but there is insufficient data show its efficacy in a clinical setting. This study is designed to image a variety of pulmonary disorders to better find possible clinical uses for hyperpolarized gas MRI.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are male or female and are 5 years or older
- •Consent/assent from the patient
- •Have been diagnosed with a pulmonary disease such as COPD, Asthma, or cystic fibrosis. OR Healthy Individuals.
- •Must be able to hold their breath for up to 15 seconds
排除标准
- •Have any contraindications to an MR exam such as a pace-maker, metallic cardiac valves, magnetic material (i.e., surgical clips) implanted electronic infusion pumps or any other conditions that would preclude proximity to a strong magnetic field;
- •Are undergoing the MR exam in an emergency situation
- •Are pregnant or become pregnant at any point within the study time.
- •People with psychiatric disorders will be excluded from the study.
- •Are claustrophobic and can not tolerate the imaging.
- •Uses supplemental oxygen
研究组 & 干预措施
Asthmatic Participants
This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
干预措施: Hyperpolarized Helium-3 (Drug)
Healthy
This population is made up of subjects who are considered clinically healthy. This means that there are no records of any chronic disorders or pulmonary history.
Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
干预措施: Hyperpolarized Helium-3 (Drug)
COPD Patients
This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.
Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
干预措施: Hyperpolarized Helium-3 (Drug)
Cystic Fibrosis Patients
This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.
Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
干预措施: Hyperpolarized Helium-3 (Drug)
结局指标
主要结局
Hyperpolarized Helium-3 MR Images
时间窗: 15 second breath-hold
We have applied hyperpolarized 3He MR imaging to a range of subject with various disorders. We have developed our scanning techniques so as to acquire optimized images for each disorder.
次要结局
未报告次要终点
研究者
Mitchell Albert
Director of Advanced MRI Center, UMASS Medical Sch
University of Massachusetts, Worcester