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

Recruiting now

Conditions studied: Cystic Fibrosis, Ventilatory Defect

In brief

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.

Key facts

Study ID: NCT06057714
Run by: University of North Carolina, Chapel Hill
People needed: 30
Starts: 2021-01-20
Expected to finish: 2026-08-01
Last updated by the study team: 2026-07-02

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects must be ≥18 years of age
Non-smokers (<10 pack/year history and no active smoking in the past year)
Diagnosis of cystic fibrosis via standard sweat chloride/phenotypic features/genotyping
No use of supplemental oxygen
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
Evidence of a personally signed and dated consent indicating that the subject has been informed of all pertinent aspects of the trial
Subjects must be willing and able to comply with scheduled visits and other trial procedures

You may not qualify if…

Subjects presenting with any of the following will not be included in the trial:
Active or past smokers or vapers with less than 1 year since quitting or >10 pack-year smoking history
Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications including
Occupation (past or present) of machinist, welder, or grinder;
Injury to the eye involving a metallic object
Injury to the body by a metallic object (bullet, bullet ball, shrapnel)
Presence of a cardiac pacemaker or defibrillator
Presence of aneurysm clips
Presence of carotid artery vascular clamp
Presence of neurostimulator
Presence of insulin or infusion pump
Presence of implanted drug infusion device that is not known to be MRI compatible (i.e., was placed outside of UNC or is older than 10 years)
Bone growth or fusion simulator
Presence of cochlear, otologic or ear implant
Any type of prosthesis (eye, penile, etc.)
Artificial limb or joint
Non-removable electrodes (on body, head or brain)
Intravascular stents, filters or coils
Shunt (spinal or intraventricular)
Swan-Ganz catheter
Any implant held in place by a magnet
Transdermal delivery system (e.g. Nitro)
An intrauterine device or diaphragm that is not MRI compatible
Tattooed makeup (eyeliner, lips, etc.) or tattoos covering >25% of body surface area
Body piercings (must be removed before MRI)

Where it is running

Univeristy of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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