Taking people in United StatesNo phase

Imaging lung airflow in adults with cystic fibrosis using inhaled-gas MRI

Uses inhaled-gas MRI to track lung airflow in adults with cystic fibrosis over a year.

Key facts

Who runs it: University of North Carolina, Chapel Hill
Where: Chapel Hill, United StatesSee the site
Trial code: NCT06057714
Registry title: Quantitation and Spatial Registration of Airways Dysfunction With Dynamic 19F MRI in Cystic Fibrosis
Status: Recruiting
People taking part: 30 people, planned
Started: 20 Jan 2021
Planned end: Aug 2026
Type of study: Observational
Treatments tested: 19F MRI
Record updated: 2 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with cystic fibrosis and mild lung disease who can have an MRI scan. They are followed for about a year.

Age: 18 years or older (up to 99 years)
Sex: All sexes can join.
Disease stage: Cystic fibrosis with stable lung function, FEV1 of 60% or more of predicted, and no flare-up (pulmonary exacerbation) in the past 4 weeks.
Earlier treatment: No change in medications that may affect CF lung disease in the past 28 days, including experimental therapies. No supplemental oxygen.
Biomarker or test result: Cystic fibrosis diagnosed by sweat chloride test, typical features or genotyping.

Main reasons for not taking part

Smokers or vapers who quit less than 1 year ago, or more than 10 pack-years of smoking
Cannot have a 3.0-Tesla MRI (for example pacemaker, metal implants, claustrophobia)
Cannot tolerate breathing the gas mixture
Pregnancy
Other severe illness that makes joining unsafe, in the investigator's judgment

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

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

Who cannot take part

Presence of facial hair that may interfere with the fit of the mask (and unwillingness to shave prior to each MRI)
Pregnancy; women of childbearing potential must have a confirmed negative urine pregnancy test on the day of the MR scan, prior to the MRI scan
Any changes in medications that may affect CF lung disease in the past 28 days, including any experimental therapies
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial
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); Any metal fragments; Internal pacing wires; Metal or wire mesh implants; Hearing aid (remove before MRI) aa. Dentures (remove before MRI) bb. Claustrophobia
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 tolerate inhalation of gas mixture

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 99 years old?

Where in United States

Univeristy of North Carolina at Chapel HillChapel Hill, United StatesContact: Jennifer L Goralski, MDTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

All Participants
All subjects to receive inhaled perfluoropropane via standard Douglas bag at every visit (3-5 visits). They will breathe the gas for 5 breath hold cycles (variable volumes as lung capacity/size varies per participant). Not to exceed 30 liters inhaled at each visit as this is the max capacity of our Douglas bag.
Treatment: 19F MRI