Actively Recruiting

Age: 6Years - 17Years
All Genders
Healthy Volunteers
ID06066723

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

Led by University of North Carolina, Chapel Hill · Updated on 2026-02-17

15

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of North Carolina, Chapel Hill

Lead Sponsor

C

Cystic Fibrosis Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the use of a new imaging technique called 19F MRI that uses an inert gas, perfluoropropane mixed with oxygen, to visualize lung ventilation. This method has not been tested in children before. The study involves children and adolescents aged 6 to 17 years with cystic fibrosis (CF) who have normal lung function, as well as a group of healthy children of the same age range. The goal is to assess if this imaging can be done successfully in the pediatric population and compare results between the two groups. Participants will inhale perfluoropropane gas during MRI scans using two techniques: standard breath holds and a novel free-breathing method that avoids breath holding. Each participant will breathe the gas for five breath hold cycles, with volumes adjusted for their lung size. Both children with CF and healthy children will undergo these procedures to compare lung ventilation images and lung function measures. During the single study visit, participants will undergo 19F MRI scans and lung function tests including spirometry and multiple breath nitrogen washout (MBW). Researchers will assess how well children tolerate the procedures using acceptability scores from both parents and children. The main focus is on the feasibility of performing these scans in children, with secondary measures assessing lung ventilation details. The study lasts for recruitment over two years and includes participation and completion rates as key outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6 to 17 years
  • Non-smoker and non-vaper
  • Diagnosis of cystic fibrosis for CF group
  • No use of supplemental oxygen
  • Able to perform spirometry with stable lung function (within 10% of personal best in last 6 months)
  • No lung exacerbations within past 4 weeks
  • Baseline FEV1 greater than 80% with FEV1:FVC ratio greater than 0.7
Not Eligible

You will not qualify if you...

  • Healthy volunteers with any history of chronic lung disease such as asthma
  • Active or former smokers who quit less than 1 year ago
  • Contraindications to MRI including metallic injuries or implants, cochlear or ear implants, shunts, magnetic implants, or claustrophobia
  • Unable to tolerate inhaling the gas mixture
  • Facial hair preventing a tight mask fit
  • Pregnancy
  • Medication changes affecting CF lung disease or lung function in past 28 days, including experimental therapies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single day

Participants undergo 19F MRI involving inhalation of a biologically inert contrast gas during breath-hold and free-breathing techniques to assess lung ventilation.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

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Research Team

J

Jennifer L Goralski, MD

C

Caroline Flowers, BS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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