HARDWARE AND SOFTWARE DEVELOPMENT FOR PULMONARY MAGNETIC RESONANCE IMAGING USING INHALED INERT HYPERPOLARIZED ¹²⁹XENON GAS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Signal-to-noise ratio (SNR)
研究概览
简要总结
Healthy volunteers aged 18 to 85 will undergo hyperpolarized Xenon-129 (¹²⁹Xe) MRI and pulmonary function testing. The study aims to develop evaluation tools for ventilation defect percent (VDP), signal-to-noise and contrast-to-noise ratios (SNR/CNR) of ¹²⁹Xe dissolved-phase images, and spectroscopy-based analysis.
详细描述
Briefly, during a one hour visit, subjects will provide written informed consent and then undergo:
- brief medical history and vital signs,
- full pulmonary function tests,
- proton MRI,
- spin-density, diffusion weighted, and/or dissolved phase 129-Xe MRI, Full pulmonary function tests including spirometry and FeNO test according to American Thoracic Society (ATS) guidelines.
Subjects will be placed in the 3T Magnetic Resonance (MR) scanner with one 129-Xe chest coil fitted over their torso and chest. Hearing protection will be provided to each subject to muffle the noise produced by the gradient radiofrequency (RF) coils. A pulse oximeter lead will be attached to all of the subjects to monitor their heart rate and oxygen saturation. MRI will be performed for up to a period of 30 minutes. All subjects will have supplemental oxygen available via nasal cannula at a flow-rate of 2 liters per minute as a precaution in the event of oxygen desaturation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient understands study procedures and is willing to participate in the study as indicated by the patient's signature.
- •Provision of written, informed consent prior to any study specific procedures.
- •Males and females aged 18 to 85 years.
- •Participant must be able to perform a breath-hold for 16s.
- •Participant has a BMI between 18 and 40
- •Participant must be able to perform reproducible pulmonary function tests (i.e., the 3 best acceptable spirograms have forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater)
- •Participants are judged to be in stable health on the basis of medical history
排除标准
- •Patient has an MR incompatible implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist).
- •In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI or CT, such as severe claustrophobia.
- •Participants who are pregnant, breastfeeding or have a positive pregnancy test at initial screening visit.
- •Participant is unable to perform spirometry maneuvers.
- •Participant is unable to perform MRI and CT breath-hold maneuvers.
- •Participant has a history of chronic or acute respiratory disease
- •FEV1 <70%
- •Participant has a history of cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, severe hypertension (≥160 over ≥100)
- •Participant has a daytime room air oxygen saturation ≤ 92% ± 2% while supine
研究组 & 干预措施
Hyperpolarized Xenon MRI
Participants will undergo pulmonary function tests, 129 Xenon MRI at the visit.
干预措施: Hyperpolarized Xenon MRI (Device)
结局指标
主要结局
Signal-to-noise ratio (SNR)
时间窗: 5 years
A quantitative measure of image quality that compares the level of the desired signal to the background noise in an MRI image.
Contrast-to-noise ratio (CNR)
时间窗: 5 years
A measure of how well different tissues or structures can be distinguished from each other in an image relative to background noise.
Image spatial resolution
时间窗: 5 years
The primary endpoints are to assess the necessary imaging sequences, reconstruction algorithms, and hardware to acquire high spatial resolution lung images from MRI. Image spatial resolution (mm) is the ability of the imaging system to distinguish small structures, expressed as the smallest detectable detail in millimeters.
Scan duration (minutes)
时间窗: 5 years
The total time required to complete the imaging acquisition for the protocol, measured in minutes.
次要结局
- Ventilation Defect Percent (VDP) of the lung(5 years)
研究者
Alexei Ouriadov
PhD, professor, scientist
Western University