Using 19F MRI to study lung ventilation in children with cystic fibrosis
A Cross-sectional Pilot Study of 19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease
This study is testing a new MRI method to see how well children with mild cystic fibrosis breathe compared to healthy kids their age.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06066723 on ClinicalTrials.gov |
What this trial studies
This observational study utilizes 19F MRI technology to visualize lung ventilation in children aged 6-17 with mild cystic fibrosis and compares the results to healthy children of the same age. Participants will inhale a perfluorinated gas mixed with oxygen, allowing researchers to assess lung function and ventilation. The study aims to evaluate the feasibility of this imaging technique in a pediatric population and compare it with traditional lung function tests like spirometry and multiple breath nitrogen washout. The primary focus is on children with stable lung function and no recent exacerbations.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 6-17 with a diagnosis of cystic fibrosis and stable lung function.
Not a fit: Patients with chronic lung diseases other than cystic fibrosis or those unable to undergo MRI due to contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of lung function in children with cystic fibrosis and improve early detection of lung disease.
How similar studies have performed: While the use of 19F MRI is novel in this context, similar imaging techniques have shown promise in other populations, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer L Goralski, MD — UNC Chapel Hill
- Study coordinator: Jennifer L Goralski, MD
- Email: jennifer_goralski@med.unc.edu
- Phone: 919-445-0331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.