Clinical trial NCT06066723: 19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease
Official title: A Cross-sectional Pilot Study of 19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cystic Fibrosis in Children
Keywords: 19F MRI
ventilation
pediatrics
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-10-04
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Participation rate
timeFrame: through study completion, recruitment for 2 years
measure: Completion rate
timeFrame: through study completion, recruitment for 2 years
measure: Parental acceptability score
timeFrame: Day 1, assessed at single visit
measure: Child acceptability score
timeFrame: Day 1, assessed at single visit
Secondary outcomes:
measure: MRI defined ventilation defect parameters (VDP) in healthy participants
timeFrame: Day 1, assessed at single visit
measure: MRI defined fraction of lung volume with slow gas washout time (FLVlongtau2) in healthy participants
timeFrame: Day 1, assessed at single visit
measure: MRI defined VDP in participants with cystic fibrosis
timeFrame: Day 1, assessed at single visit
measure: MRI defined fraction of lung volume with slow gas washout time (FLVlongtau2) in participants with cystic fibrosis
timeFrame: Day 1, assessed at single visit
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Jennifer L Goralski, MD
role: PRINCIPAL_INVESTIGATOR
References: