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

Cystic Fibrosis in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06066723
• Other study ID #: 23-0700
• Secondary ID: 5K23HL138257-03
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Jennifer L Goralski, MD
• Phone: 919-445-0331
• Email: jennifer_goralski[@]med.unc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis in Children
• Fibrosis
• Lung Diseases
• Pulmonary Fibrosis

Intervention

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.

Locations

Country	Name	City	State
United States	Univeristy of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Cystic Fibrosis Foundation, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation rate	The number of eligible participants approached for the study divided by the number who consent to participate.	through study completion, recruitment for 2 years
Primary	Completion rate	The number of consented participants divided by the number of participants who complete each portion of the study.	through study completion, recruitment for 2 years
Primary	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	Day 1, assessed at single visit
Primary	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	Day 1, assessed at single visit
Secondary	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)	Day 1, assessed at single visit
Secondary	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)	Day 1, assessed at single visit
Secondary	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)	Day 1, assessed at single visit
Secondary	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)	Day 1, assessed at single visit