19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06066723

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH), Cystic Fibrosis Foundation (Other)

Enrollment

Location

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis in Children	Combination Product: 19F MRI

Study Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

A Cross-sectional Pilot Study of 19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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).	Combination Product: 19F MRI Inhalation of a biologically inert contrast gas, perfluoropropane, combined with 19F-tuned MRI with image acquisition at breath-hold and during tidal breathing. Other Names: PFP
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).	Combination Product: 19F MRI Inhalation of a biologically inert contrast gas, perfluoropropane, combined with 19F-tuned MRI with image acquisition at breath-hold and during tidal breathing. Other Names: PFP

Arm

Intervention/Treatment

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).

Combination Product: 19F MRI

Inhalation of a biologically inert contrast gas, perfluoropropane, combined with 19F-tuned MRI with image acquisition at breath-hold and during tidal breathing.

Other Names:

PFP

Healthy Children

Combination Product: 19F MRI

Inhalation of a biologically inert contrast gas, perfluoropropane, combined with 19F-tuned MRI with image acquisition at breath-hold and during tidal breathing.

Other Names:

PFP

Outcome Measures

Primary Outcome Measures

Participation rate [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 [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.
Parental acceptability score [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
Child acceptability score [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

Secondary Outcome Measures

MRI defined ventilation defect parameters (VDP) in healthy participants [Day 1, assessed at single visit]
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 [Day 1, assessed at single visit]
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 [Day 1, assessed at single visit]
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 [Day 1, assessed at single visit]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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