Repeatability in Hyperpolarized 3-Helium Magnetic Resonance Imaging
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels.
研究概览
简要总结
The main purpose of this study is to assess and test the reproducibility and results of hyperpolarized 3-Helium gas as a contrast agent with Magnetic Resonance Imaging (MRI) of the lungs in healthy adult subjects.
详细描述
New CT imaging techniques often expose the patient to higher doses of radiation. There is a great deal of concern about effects of medical radiation exposure on the general public and regulations are becoming stricter on the radiation doses that are allowed.
One novel procedure that has been developed to evaluate the function and structure of the lung is the use of hyperpolarized gases with MRI scanners. We want to compare the lung imaging techniques that we have developed in our lab to a technique that uses hyperpolarized 3-Helium gas with MRI. This technique is free from radiation and less invasive than many lung imaging techniques.
Hyperpolarized gas MRI is based on the introduction of spins into the lungs, allowing imaging to take place. The use of hyperpolarized 3-Helium has a few advantages:
- it allows us to see the microstructure of the lungs through diffusion imaging (apparent diffusion coefficient) which correlates with the size of airways and alveolar space.
- it allows us to see ventilation, or how air moves in the lungs, at a high resolution.
- it is capable of ultra fast imaging which will help us assess gas flow patterns within the airways.
and 4) the speed of depolarization lets us measure the partial pressure of oxygen and associated gas exchange mechanisms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •must be between the ages of 18 and 90
- •must have a Body Mass Index (BMI) of < 32 and weigh < 200 lbs.
排除标准
- •if female, must not be pregnant or breastfeeding
- •must not have any metal objects in or on their body including body piercings that cannot be easily removed, bullets, metallic fragments or slivers in eyes, skin, etc., pacemaker or defibrillation, aneurysm clips, cochlear implants, coronary stents, or neurostimulation.
- •must not have a history of claustrophobia, panic disorders, anxiety attacks, atrial fibrillation, uncontrolled high blood pressure, frequent ventricular ectopic rhythm, hemodynamic instability, kidney dysfunction or heart disease.
研究组 & 干预措施
Group One: Prone MRI Scans
Subjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan
干预措施: Prone hyperpolarized 3 helium gas scan (Drug)
Group One: Prone MRI Scans
Subjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan
干预措施: Vitals (Diagnostic Test)
Group One: Prone MRI Scans
Subjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan
干预措施: Pulmonary Function Tests (Diagnostic Test)
Group One: Prone MRI Scans
Subjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan
干预措施: Initial protocol MRI scan (Diagnostic Test)
Group Two: Supine MRI scans
Subjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan
干预措施: Supine hyperpolarized 3 helium gas scan (Drug)
Group Two: Supine MRI scans
Subjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan
干预措施: Vitals (Diagnostic Test)
Group Two: Supine MRI scans
Subjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan
干预措施: Pulmonary Function Tests (Diagnostic Test)
Group Two: Supine MRI scans
Subjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan
干预措施: Initial protocol MRI scan (Diagnostic Test)
结局指标
主要结局
Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels.
时间窗: Through study completion, measurements completed at one day visit only.
Validate the intrinsic variability of ADC (cm2/s) as a function of normal procedural and physiological changes in an attempt to standardize the use of the biomarker in future assessments of pulmonary pathologies.
次要结局
未报告次要终点
研究者
Eric A. Hoffman
Professor
University of Iowa