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.
6-17 years old
Non-smoker and non-vaper
Cystic Fibrosis (CF) Group: must have a diagnosis of CF
No use of supplemental oxygen
Healthy volunteers: with any history of chronic lung disease (i.e. asthma)
Active or former smoker with less than 1 year of quitting
Injury to the eye involving a metallic object
Injury to the body involving a metallic object
Healthy volunteers between the ages of 6-17 years old without known lung disease OR people with cystic fibrosis between the ages of 6-17 years
Case-control
Cross-sectional
19F MRI
Combination productInhalation of a biologically inert contrast gas, perfluoropropane, combined with 19F-tuned MRI with image acquisition at breath-hold and during tidal breathing.
Participation rate
The number of eligible participants approached for the study divided by the number who consent to participate.
Completion rate
The number of consented participants divided by the number of participants who complete each portion of the study.
Parental acceptability score
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
Child acceptability score
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
MRI defined ventilation defect parameters (VDP) in healthy participants
The 19F Volumetric interpolated breath-hold examination (VIBE) scans and proton nuclear magnetic resonance imaging (1H-MRI) will be saved as Digital Imaging and Communications in Medicine (DICOM) images and imported to Medical Image Merge (MIM) software. The percentage of lung with ventilation defects (VDP) after the 5th inspiratory cycle will be measured, using the 95th percentile of background noise on the last wash-in scan as the threshold value defining absence of ventilation. The investigators will assess ventilation defect parameters (VDP) scored in healthy participants (mean + SD)
MRI defined fraction of lung volume with slow gas washout time (FLVlongtau2) in healthy participants
The 19F Volumetric interpolated breath-hold examination (VIBE) scans and 1H-MRI will be saved as Digital Imaging and Communications in Medicine (DICOM) images and imported to Medical Image Merge (MIM) software. The fraction of the total lung volume with slow gas wash-out kinetics (FLV↑tau2) will be calculated for lung regions without an overlapping full ventilation defect. The investigators will assess FLVlongtau2 scored in healthy participants (mean + SD)
MRI defined VDP in participants with cystic fibrosis
The 19F VIBE scans and 1H-MRI will be saved as Digital Imaging and Communications in Medicine (DICOM) images and imported to Medical Image Merge (MIM) software. The percentage of lung with ventilation defects (VDP) after the 5th inspiratory cycle will be measured, using the 95th percentile of background noise on the last wash-in scan as the threshold value defining absence of ventilation. The investigators will assess ventilation defect parameters (VDP) scored in participants with cystic fibrosis (mean + SD)
MRI defined fraction of lung volume with slow gas washout time (FLVlongtau2) in participants with cystic fibrosis
The 19F Volumetric interpolated breath-hold examination (VIBE) scans and 1H-MRI will be saved as Digital Imaging and Communications in Medicine (DICOM) images and imported to Medical Image Merge (MIM) software. The fraction of the total lung volume with slow gas wash-out kinetics (FLV↑tau2) will be calculated for lung regions without an overlapping full ventilation defect. The investigators will assess FLVlongtau2 scored in participants with cystic fibrosis (mean + SD)
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University of North Carolina, Chapel Hill
Lead sponsor
Cystic Fibrosis Foundation
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
