Structure and Function MRI of Asthma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Ventilation Defect Percent as measured by Xenon-129 and/or Helium-3 MRI
研究概览
简要总结
The investigators will apply 129Xenon and/or 3He image acquisition and analysis methods in 200 asthma patient volunteers in order to characterize and probe the relationship between lung structure and function using imaging.
详细描述
This is an exploratory, longitudinal study with no medication evaluated. 200 asthma patients will visit the Clinical Imaging Research Laboratories at Robarts Research Institute two times over three years: at baseline, and at three years. For the first 60 subjects there will be 3 additional visits - two visits within 4 weeks of baseline (BL+2 weeks; BL+4 weeks; BL+78 weeks) in order to help generate reproducibility data and temporal maps.
For all subjects, the Baseline visit will include 129Xe and/or 3He MRI, chest CT, sputum induction, Pulmonary Function Tests, Airwave Oscillation test, Lung Clearance Index test, BORG Dyspnea Scale, and MRC Dyspnea Scale. All procedures will be before, during and after methacholine challenge (MCh). For V2, all but CT and MCh will be acquired.
Visits 1a and 1b will include MRI, Pulmonary Function Tests including Airwave Oscillation and Lung Clearance Index, and dyspnea questionnaires; Visit 1c will also include sputum induction.
There will be a telephone call at 52+/- 2 weeks, and 104 +/- 2 weeks. to track exacerbations and update medications. Subjects will complete self-assessments in the form of a) the Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ(S)) bi-weekly, and the Asthma Control Diary (weekly) between visits. Self-reported data (the weekly asthma control diary and bi-weekly AQLQ(S)) will be uploaded by each subject monthly to the investigators website using a confidential and password protected upload (www.imaging.robarts.ca/\~gep/ForPatients.htm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects male and female aged 18-60 with a clinical diagnosis of asthma
- •Smoking history ≤ 1 pack/year
- •Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
- •Subject is judged to be in otherwise stable health on the basis of medical history
- •Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)
- •FEV1 >60% predicted
排除标准
- •Patient is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material
- •Patient is unable to perform spirometry or plethysmography maneuvers
- •Subject has an 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/3T Manager)
- •In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia.
- •Patient is pregnant
研究组 & 干预措施
Asthma Patients
All enrolled asthma patients will undergo hyperpolarized noble gas MRI with Helium-3 and/or Xenon-129, Pulmonary Function Tests, Quality of Life Questionnaires, dyspnea scales in two visits over three years.
干预措施: Hyperpolarized Noble Gas MRI (Other)
结局指标
主要结局
Ventilation Defect Percent as measured by Xenon-129 and/or Helium-3 MRI
时间窗: 3 years
VDP is a widely used noble gas MRI biomarkers that is calculated by normalizing ventilation defect volume to the thoracic cavity
次要结局
- Forced Expiratory Volume (FEV1) measured by spirometry(3 years)
- Additional Pulmonary Function measurements(3 years)
- Dyspnea Scale(3 years)
- Quality of Life questionnaires(3 years)
研究者
Dr. Grace Parraga
PhD, Scientist. Robarts Research Institute
Western University, Canada