Quantitation and Spatial Registration of Airways Dysfunction With Dynamic 19F MRI in Cysti
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 meas
| Condition(s) | Cystic Fibrosis, Ventilatory Defect |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 experi |
| Who can participate | Inclusion Criteria: 1. Subjects must be ≥18 years of age 2. Non-smokers (\<10 pack/year history and no active smoking in the past year) 3. Diagnosis of cystic fibrosis via standard sweat chloride/phenotypic features/genotyping 4. No use of supplemental oxygen 5. Stable lung function (within 10% of personal best in the last 6 months) with no pulmonary exacerbations in the past 4 weeks and baseline FEV1≥60% of predicted 6. Evidence of a personally signed and dated consent indicating that the subject has been informed of all pertinent aspects of the trial 7. Subjects must be willing and able to comply with scheduled visits and other trial procedures Exclusion Criteria: Subjects presenting with any of the following will not be included in the trial: 1. Active or past smokers or vapers with les |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Lead sponsor | University of North Carolina, Chapel Hill |
| Locations | Chapel Hill, North Carolina, United States |
| Start date | 2021-01-20 |
| NCT ID | NCT06057714 |
| Official listing | https://clinicaltrials.gov/study/NCT06057714 |