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NCT Number: NCT06066723

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

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.

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Key information

Conditions

Cystic Fibrosis in Children Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location status: Recruiting

Location contact

Jennifer L Goralski, MD

CONTACT

[email protected]

919-445-0331

Jennifer L Goralski, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

19F MRI

Combination Product

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

Primary outcomes

  1. Participation rate

    Time frame: through study completion, recruitment for 2 years

    The number of eligible participants approached for the study divided by the number who consent to participate.

  2. Completion rate

    Time frame: 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.

  3. Parental acceptability score

    Time frame: 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

  4. Child acceptability score

    Time frame: 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 outcomes

  1. MRI defined ventilation defect parameters (VDP) in healthy participants

    Time frame: 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)

  2. MRI defined fraction of lung volume with slow gas washout time (FLVlongtau2) in healthy participants

    Time frame: 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)

  3. MRI defined VDP in participants with cystic fibrosis

    Time frame: 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)

  4. MRI defined fraction of lung volume with slow gas washout time (FLVlongtau2) in participants with cystic fibrosis

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Flowers, BS

CONTACT

[email protected]

984-974-2962

Jennifer L Goralski, MD

CONTACT

[email protected]

919-445-0331

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 4, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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