Actively Recruiting

Age: 18Years - 99Years
All Genders
NCT06057714

Quantitation and Spatial Registration of Airways Dysfunction With Dynamic 19F MRI in Cystic Fibrosis

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

30

Participants Needed

1

Research Sites

279 weeks

Total Duration

On this page

Sponsors

U

University of North Carolina, Chapel Hill

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to look at lung ventilation in people with cystic fibrosis over time (1 year) using magnetic resonance imaging (MRI) with an inhaled contrast gas, and compare these measures to lung function assessed by spirometry and multiple breath nitrogen washout. This study also looks at how these measures change in response to a pulmonary exacerbation and treatment (if applicable). Over the span of a year, participants would be asked to complete 3-5 visits to the University of North Carolina at Chapel Hill (UNC). with each lasting up to 4 hours. If participants do not have a pulmonary exacerbation during the year they would be asked to complete 3 visits (one at enrollment, a second roughly 2 weeks later, and the third approximately a year later). If participants do experience a CF pulmonary exacerbation they would complete 5 visits (Visit 1, Visit 2, two exacerbation visits with one before treatment and the other after, and Visit 3 at one year after Visit 1). Only one exacerbation per participant will be tracked. Participants are eligible for this study if they are 18 years old or older, have Cystic Fibrosis (CF) with mild lung disease (FEV1 \>/= 60%), and can undergo an MRI. There are no known benefits for participating in this study.

CONDITIONS

Official Title

Quantitation and Spatial Registration of Airways Dysfunction With Dynamic 19F MRI in Cystic Fibrosis

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must be 18 years of age or older
  • Non-smoker with less than 10 pack-years and no active smoking in the past year
  • Diagnosis of cystic fibrosis confirmed by sweat chloride, phenotypic features, or genotyping
  • No use of supplemental oxygen
  • Stable lung function within 10% of personal best in last 6 months with baseline FEV1 of 60% or higher
  • Signed informed consent
  • Willing and able to attend scheduled visits and follow study procedures
Not Eligible

You will not qualify if you...

  • Active or past smokers or vapers with less than 1 year since quitting or more than 10 pack-year smoking history
  • Unable to undergo 3.0-Tesla MRI due to contraindications such as metal implants, pacemakers, aneurysm clips, cochlear implants, or other listed devices
  • Unable to tolerate inhalation of the gas mixture
  • Presence of facial hair interfering with mask fit and unwillingness to shave
  • Medication changes affecting CF lung disease in past 28 days, including experimental therapies
  • Severe acute or chronic medical or psychiatric conditions that increase risk or interfere with study
  • Pregnancy or positive pregnancy test on day of MRI scan

AI-Screening

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Trial Site Locations

Total: 1 location

1

Univeristy 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

CONTACT

M

Margret Z Powell, BS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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