Recruiting

MRI

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06066723

Conditions

Cystic Fibrosis in Children

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Accepted

Interventions

19F MRI

Study Details

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.

Conditions

Cystic Fibrosis in Children

Study ID

NCT06066723

Start date

Jun 16, 2025

Status verified date

Feb, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Accepted

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

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

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).

Interventions

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.

Primary outcome measure

  • Participation rate [ Time Frame: through study completion, recruitment for 2 years ]
  • Completion rate [ Time Frame: through study completion, recruitment for 2 years ]
  • Parental acceptability score [ Time Frame: Day 1, assessed at single visit ]
  • Child acceptability score [ Time Frame: Day 1, assessed at single visit ]

Central Contacts and Locations

Central contacts

Jennifer L Goralski, MD

919-445-0331jennifer_goralski@med.unc.edu

Caroline Flowers, BS

984-974-2962caroline_flowers@med.unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Jennifer L Goralski, MD

919-445-0331jennifer_goralski@med.unc.edu

Principal Investigator:

Jennifer L Goralski, MD

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Jul 2, 2026

Last verified

Feb, 2026

Keywords

  • 19F MRI
  • ventilation
  • pediatrics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-07-02.