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

NCT06066723 | Recruiting DMC FDA Drug

• 2 other identifiers: 23-07005K23HL138257-03
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

19F MRI; ventilation; pediatrics

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• MRI defined ventilation defect parameters (VDP) in healthy participants

  Day 1, assessed at single visit

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

  Day 1, assessed at single visit

• MRI defined VDP in participants with cystic fibrosis

  Day 1, assessed at single visit

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

  Day 1, assessed at single visit

Study Arms (2)

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

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

Interventions

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.

Also known as: PFP

Children with CF; Healthy Children

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Cystic Fibrosis Foundation: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer L Goralski, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer L Goralski, MD

CONTACT

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

Caroline Flowers, BS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 4, 2023
• Study Start: June 16, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)