Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Ventilation imaging resolution comparison between MRI and scintigraphy
研究概览
简要总结
Hyper polarized Xenon-129 MRI will be directly compared to a radioactive Xe-133 scintigraphy to detect defects in lung ventilation from airflow limitation. This study is conducted as a pilot study with intention to conduct a larger clinical trial.
详细描述
Hyperpolarized Xenon-129 MRI has been developed by a number of techniques for imaging the lung that provide information about various aspects of lung function and structure. The main objective of this pilot study is to test and optimize the imaging parameters for a future industry sponsored clinical trial. The goal of the future trial is to determine the concordance between hyperpolarized xenon-129 ventilation MR imaging and nuclear medicine ventilation imaging (Gold Standard). In this study we will test the imaging parameters and techniques. We will directly compare human ventilation lung images in subjects with COPD, using nuclear medicine ventilation imaging with Xenon-133 gas scintigraphy versus hyperpolarized xenon-129 gas MRI. Our hypothesis is that current Xe-133 scintigraphy, which uses a radioactive gas (Xe-133) and produces a projection image of the lungs with relatively poor resolution, will not be able to detect small lung ventilation obstructions, which can be detected using hyperpolarized Xe-129 gas MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Subjects must have a diagnosis of COPD
- •at their clinical baseline on the day of imaging
- •must be clinically stable in order to participate in the study.
- •COPD subjects will be categorized according to the GOLD
- •Current/Former SmokerSubjects
- •must have a smoking history ≥ 10 pack years
排除标准
- •Dx of asthma
- •Continuous oxygen use at home
- •Blood oxygen saturation of 92% less than as measured by pulse oximetry on the day of imaging
- •FEV1 percent predicted less than 25%
- •Pregnancy or lactation
- •Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning
- •Subjects with any implanted device that cannot be verified as MRI compliant will be excluded
- •Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches
- •History of congenital cardiac disease, chronic renal failure, or cirrhosis
- •Inability to understand simple instructions or to hold still for approximately 10 seconds
- •History of respiratory infection within 2 weeks prior to the MR scan
- •History of MI, stroke and/or poorly controlled hypertension.
研究组 & 干预措施
COPD patients - Xe-133
COPD patients who will be assessed with Xenon-133 scintigraphy (Standard diagnostic study)
干预措施: Radioactive Xenon-133 scintigraphy (Active Comparator) (Drug)
COPD patients - Hyperpolarized Xe-129
COPD patients crossed over from the Active Comparator Arm who will be assessed with hyper polarized Xenon-129 MRI (Experimental diagnostic study)
干预措施: Hyperpolarized Xenon-129 MRI (Experimental) (Drug)
结局指标
主要结局
Ventilation imaging resolution comparison between MRI and scintigraphy
时间窗: 12 months
Compare the quality of the imaging between hyper polarized xenon-129 and radioactive xenon-133
次要结局
未报告次要终点
研究者
Y. Michael Shim, MD
Associate Professor
University of Virginia