HARDWARE AND SOFTWARE DEVELOPMENT FOR PULMONARY MAGNETIC RESONANCE IMAGING USING INHALED INERT FLOURINATED 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
- 2
- 主要终点
- Image spatial resolution
研究概览
简要总结
Healthy volunteers aged 18 to 85 will undergo ¹⁹F (perfluoropropane) MRI to support the development of imaging sequences, reconstruction algorithms, and hardware necessary for acquiring high-spatial resolution lung images. The study will also evaluate signal-to-noise ratio, contrast-to-noise ratio, spatial resolution, scan duration, and pulmonary gas exchange measurements derived from ¹⁹F (perfluoropropane) MRI.
详细描述
Briefly, during this two-hour visit, participants will provide written informed consent and then undergo:
- Brief medical history and vital signs,
- Full pulmonary function tests,
- Proton MRI,
- 19F(perfluoropropane) MRI, As part of the MRI, participants will inhale or 19F gas as a contrast agent to assess lung ventilation Spirometry will be performed at each visit according to American Thoracic Society (ATS) guidelines using MedGraphics Elite Series (MedGraphics Corporation. St. Paul, MN USA) and/or nDD EasyOne Spirometer (nDD Medical Technologies Inc. Andover, MA USA). Fractional exhaled nitric oxide (FeNO) will be measured using the NIOX VERO® (Circassia Pharmaceuticals Inc., Morrisville, NC, USA). All measurements will be performed at St Joseph's Healthcare London.
They will be placed in the 3T PET/MRI scanner with a coil fitted over their torso and chest. Hearing protection will be provided to muffle the noise produced by the 3D imaging gradient coils. A pulse oximeter lead will be used to monitor heart rate and oxygen saturation. MRI will be performed for up to a period of seven to ten minutes. All imaging will be performed in a "breath-hold" fashion. All participants will have supplemental oxygen provided via nasal cannula at a flow rate of at least two liters per minute during the scanning process. Logs and records of gas exposure will be maintained for every volunteer in this study.
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
- •Participants eligible for inclusion in this study must meet all of the following criteria:
- •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
- •Participants fulfilling any of the following criteria are not eligible for inclusion in this study:
- •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
- •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
¹⁹F (perfluoropropane) MRI
Participants will undergo pulmonary function tests, ¹⁹F (perfluoropropane) MRI at the visit.
干预措施: 19F(perfluoropropane) MRI (Device)
结局指标
主要结局
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. Higher spatial resolution (smaller values) allows finer anatomical detail to be visualized.
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. Higher SNR values indicate clearer images with less noise, allowing for better visualization of anatomical structures.
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. Higher CNR indicates better contrast and improved visibility of anatomical differences.
Scan duration (minutes)
时间窗: 5 years
The total time required to complete the imaging acquisition for the protocol, measured in minutes.
Signal-to-noise ratio, Contrast-to-noise ratio, Image spatial resolution, and scan duration
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,
次要结局
- Ventilation Defect Percent (VDP) of the lung(5 years)
- Fractional Ventilation (r)(5 years)
研究者
Alexei Ouriadov
PhD, professor, scientist
Western University