RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-01
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06066723

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 6-17 years old
  2. * Non-smoker and non-vaper
  3. * Cystic Fibrosis (CF) Group: must have a diagnosis of CF
  4. * No use of supplemental oxygen
  5. * 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
  6. * 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
  1. * Healthy volunteers: with any history of chronic lung disease (i.e. asthma)
  2. * Active or former smoker with less than 1 year of quitting
  3. * Unable to undergo an MRI of the lungs and chest because of contraindications, including:
  4. * Injury to the eye involving a metallic object
  5. * Injury to the body involving a metallic object
  6. * Presence of an implanted drug infusion device that is not MRI safe
  7. * Bone growth of fusion simulator
  8. * Presence of cochlear, otologic, or ear implant
  9. * Shunt (spinal or intraventricular)
  10. * Any implant held in place by magnet
  11. * Claustrophobia
  12. * Unable to tolerate the inhalation of the gas mixture
  13. * Facial hair preventing a tight fit of the mask used in the study
  14. * Pregnancy
  15. * Changes in medication that may affect CF lung disease or lung function in the past 28 days, including experimental therapies

Contacts and Locations

Study Contact

Jennifer L Goralski, MD
CONTACT
919-445-0331
jennifer_goralski@med.unc.edu
Margret Z Powell, BS
CONTACT
984-974-2962
margret_powell@med.unc.edu

Principal Investigator

Jennifer L Goralski, MD
PRINCIPAL_INVESTIGATOR
UNC Chapel Hill

Study Locations (Sites)

Univeristy of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Jennifer L Goralski, MD, PRINCIPAL_INVESTIGATOR, UNC Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • 19F MRI
  • ventilation
  • pediatrics

Additional Relevant MeSH Terms

  • Cystic Fibrosis in Children