Development of Magnetic Resonance Imaging Airway Segmentation to Assess and Monitor Cystic Fibrosis Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Airway Lumen Diameter measured by UTE MRI
研究概览
简要总结
This study is being done to determine whether MRI can produce high quality lung and airway images in healthy and CF patients and if MRI can be used to evaluate size and shape of the airways with computer assistance. This study will also repeat MRI experiments two years after the initial MRI scan to see if changes to airway size and shape are seen over time. In a subset of participants, we will investigate whether MRI results are repeatable and reproducible in the short-term one week after the initial MRI visit. This study will help understand if MRI based measurements of airway size and shape can be used as a monitoring tool that does not use x-ray radiation in patients with CF.
详细描述
Early CF disease in the lungs is characterized by repeated infection which can alter dimensions of the airways , especially abnormal dilation of the airways (bronchiectasis) Airway tree mapping is a form of quantitative imaging that investigates segmentation and dimensionality of the upper airways. CT detects utilized to characterize airway dimension in adults with COPD, but involves ionizing radiation. Unexplored in children.
MRI: Non-invasive, radiation-free, ideal for longitudinal monitoring. However, struggles with lung imaging due to low signal intensity, short T2 relaxation times, and motion artifacts Advanced ultrashort echo time (UTE) MRI enables high-resolution airway imaging with motion correction for free-breathing airway imaging. May permit airway tree mapping in children while obviating ionizing radiation risk.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Participants must be greater than or equal to 6 years of age and not greater than 18 years of age.
- •Informed consent by patient or parent/guardian consent and participant assent when appropriate.
- •Able to perform reproducible spirometry
排除标准
- •Medical instability that would preclude the ability to undergo the required investigations
- •FEV1 % predicted < 40%
- •Severe claustrophobia
- •Does not meet MRI screening criteria
- •Usage of oral antibiotics within 3 weeks prior to study visit
- •Known pulmonary disease
- •Group 2 Inclusion Criteria
- •Diagnosis of CF as evidenced by one or more clinical feature consistent with the CF phenotype or positive CF newborn screen
- •Participants must be greater than or equal to 6 years of age and not greater than 18 years of age.
- •Informed consent by patient or parent/guardian consent and participant assent when appropriate.
- •Able to perform reproducible spirometry
- •Exclusion Criteria
- •Medical instability that would preclude the ability to undergo the required investigations
- •FEV1 % predicted < 40%
- •Severe claustrophobia
- •Does not meet MRI screening criteria
- •Worsening cough and/or sputum production within the past 3 days prior to study visit
- •The use of new oral and/or inhaled antibiotics within 3 weeks prior to study visit
- •Received intravenous antibiotics within 2 weeks prior to study visit
- •The use of supplementary oxygen
- •Status of post lung or another organ transplant
研究组 & 干预措施
Group 1
Healthy control
干预措施: Advanced ultrashort echo time (UTE) MRI - Ultrashort echo time (UTE) imaging is a technique that can quickly capture the fast-decaying 1H lung signal. (Device)
Group 1
Healthy control
干预措施: Multiple Breath Wash out (MBW) (Device)
Group 2
CF patients
干预措施: Advanced ultrashort echo time (UTE) MRI - Ultrashort echo time (UTE) imaging is a technique that can quickly capture the fast-decaying 1H lung signal. (Device)
Group 2
CF patients
干预措施: Multiple Breath Wash out (MBW) (Device)
结局指标
主要结局
Airway Lumen Diameter measured by UTE MRI
时间窗: Baseline (Visit 1A); Optional 1-week repeatability visit (Visit 1B) & 2-year follow-up (Visit 2A)
Quantitative measurement of airway lumen diameter (millimeters) across airway generations 1-6 using UTE MRI airway tree segmentation.
次要结局
- Lung Clearance Index (LCI)(Baseline (Visit 1A); Optional 1-week repeatability visit (Visit 1B) & 2-year follow-up (Visit 2A))
研究者
Brandon Zanette
Technical Innovation Investigator
The Hospital for Sick Children