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

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Sep 27, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new imaging technique called 19F MRI, which helps visualize how well the lungs are working, particularly in children with mild cystic fibrosis (CF). The study will compare children with CF, aged 6 to 17, who have stable lung function, to healthy children of the same age. Participants will inhale a safe gas during the MRI to see how well their lungs are ventilating. The main goal of this trial is to determine if this imaging method is suitable for use in children and how it compares to standard tests that measure lung function.

To be eligible for the trial, children must be between 6 and 17 years old, diagnosed with cystic fibrosis, and have stable lung health without recent flare-ups. They should not smoke or vape and must be able to perform lung function tests. Healthy children can also participate, but they must not have any history of chronic lung disease. Participants can expect to undergo an MRI and complete breathing tests, all while being closely monitored for their safety. This study is an exciting opportunity to explore a new way to assess lung health in children, potentially leading to better care for those with cystic fibrosis.

Gender

ALL

Eligibility 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