Using 19F MRI to study lung ventilation in children with cystic fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Inhaled CFTR mRNA for cystic fibrosis in Chinese patients aged 12 and older

  This trial tests inhaled BMD003, a CFTR mRNA therapy, to see if it's safe and shows early signs of benefit in Chinese people 12 years and up with cystic fibrosis.

  Recruiting Early Phase 1 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07485543

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.