A Cross-sectional Pilot Study of 19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Participation rate
研究概览
简要总结
This study capitalizes on the emerging technology of 19F MRI, using conventional 'thermally' polarized perfluorinated gas (perfluoropropane, or PFP) mixed with oxygen and studied with magnetic resonance imaging (MRI) to visualize ventilation. This technique has not been studied in children.
Children and adolescents (6-17 years old) with cystic fibrosis (CF) who have normal spirometry will undergo 19F MRI with the inhalation of an inert contrast gas to study ventilation. Comparisons will be made to a cohort of healthy children (6-17 years old) who will perform the same measures. The primary outcome measure is the feasibility of conducting these studies in the pediatric population. Parallel performance of multiple breath nitrogen washout (MBW) and spirometry will be used to compare the sensitivity of these outcomes to the presence of mild lung disease in these children. Finally, the investigators will compare data obtained during standard breath holds with a novel "free-breathing" technique that will eliminate the need for breath holds during MRI acquisition.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6-17 years old
- •Non-smoker and non-vaper
- •Cystic Fibrosis (CF) Group: must have a diagnosis of CF
- •No use of supplemental oxygen
- •They must be able to perform spirometry and have stable lung function (within 10% personal best in the last 6 months) and no exacerbations within the past 4 weeks
- •Baseline forced expiratory volume in 1 second (FEV1) >80% with ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lung (FEV1:FVC) ratio >0.7
排除标准
- •Healthy volunteers: with any history of chronic lung disease (i.e. asthma)
- •Active or former smoker with less than 1 year of quitting
- •Unable to undergo an MRI of the lungs and chest because of contraindications, including:
- •Injury to the eye involving a metallic object
- •Injury to the body involving a metallic object
- •Presence of an implanted drug infusion device that is not MRI safe
- •Bone growth of fusion simulator
- •Presence of cochlear, otologic, or ear implant
- •Shunt (spinal or intraventricular)
- •Any implant held in place by magnet
- •Claustrophobia
- •Unable to tolerate the inhalation of the gas mixture
- •Facial hair preventing a tight fit of the mask used in the study
- •Pregnancy
- •Changes in medication that may affect CF lung disease or lung function in the past 28 days, including experimental therapies
研究组 & 干预措施
Children with CF
All subjects to receive inhaled perfluoropropane during MRI procedures, including standard breath hold and free-breathing technique. Subjects will breathe the gas for 5 breath hold cycles (variable volumes as lung capacity/size varies per participant).
干预措施: 19F MRI (Combination Product)
Healthy Children
All subjects to receive inhaled perfluoropropane during MRI procedures, including standard breath hold and free-breathing technique. Subjects will breathe the gas for 5 breath hold cycles (variable volumes as lung capacity/size varies per participant).
干预措施: 19F MRI (Combination Product)
结局指标
主要结局
Participation rate
时间窗: through study completion, recruitment for 2 years
The number of eligible participants approached for the study divided by the number who consent to participate.
Completion rate
时间窗: through study completion, recruitment for 2 years
The number of consented participants divided by the number of participants who complete each portion of the study.
Child acceptability score
时间窗: Day 1, assessed at single visit
Acceptability questionnaire for participant; 2 questions, each on a 10 point Likert scale * Implementation: qualitative description of barriers encountered * Practicality: % of participants completing the study with research quality data
Parental acceptability score
时间窗: Day 1, assessed at single visit
Acceptability questionnaire for guardian; 2 questions, each on a 10 point Likert scale * Implementation: qualitative description of barriers encountered * Practicality: % of participants completing the study with research quality data
次要结局
- MRI defined fraction of lung volume with slow gas washout time (FLVlongtau2) in healthy participants(Day 1, assessed at single visit)
- MRI defined VDP in participants with cystic fibrosis(Day 1, assessed at single visit)
- MRI defined fraction of lung volume with slow gas washout time (FLVlongtau2) in participants with cystic fibrosis(Day 1, assessed at single visit)
- MRI defined ventilation defect parameters (VDP) in healthy participants(Day 1, assessed at single visit)