Measuring lung function in cystic fibrosis using advanced MRI techniques

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

This study is testing a new MRI method to see how well the lungs are working in people with cystic fibrosis over a year, comparing it to standard lung tests.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: University of North Carolina, Chapel Hill (other)
• Locations: 1 site (Chapel Hill, North Carolina)
• Trial ID: NCT06057714 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess lung ventilation in individuals with cystic fibrosis over a one-year period using dynamic 19F MRI with an inhaled contrast gas. Participants will undergo 3-5 visits to the University of North Carolina at Chapel Hill, where their lung function will be evaluated through MRI and compared to traditional spirometry and nitrogen washout tests. The study will also monitor changes in lung function in response to pulmonary exacerbations and subsequent treatments, if applicable.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of cystic fibrosis and stable lung function.

Not a fit: Patients who are active or past smokers with a significant smoking history or those unable to undergo MRI due to contraindications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new insights into lung function dynamics in cystic fibrosis, potentially leading to improved monitoring and treatment strategies.

How similar studies have performed: While the use of MRI in lung function assessment is gaining interest, this specific approach with dynamic 19F MRI in cystic fibrosis is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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 less than 1 year since quitting or \>10 pack-year smoking history
2. Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications including

   1. Occupation (past or present) of machinist, welder, or grinder;
   2. Injury to the eye involving a metallic object
   3. Injury to the body by a metallic object (bullet, bullet ball, shrapnel)
   4. Presence of a cardiac pacemaker or defibrillator
   5. Presence of aneurysm clips
   6. Presence of carotid artery vascular clamp
   7. Presence of neurostimulator
   8. Presence of insulin or infusion pump
   9. 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)
   10. Bone growth or fusion simulator
   11. Presence of cochlear, otologic or ear implant
   12. Any type of prosthesis (eye, penile, etc.)
   13. Artificial limb or joint
   14. Non-removable electrodes (on body, head or brain)
   15. Intravascular stents, filters or coils
   16. Shunt (spinal or intraventricular)
   17. Swan-Ganz catheter
   18. Any implant held in place by a magnet
   19. Transdermal delivery system (e.g. Nitro)
   20. An intrauterine device or diaphragm that is not MRI compatible
   21. Tattooed makeup (eyeliner, lips, etc.) or tattoos covering \>25% of body surface area
   22. Body piercings (must be removed before MRI)
   23. Any metal fragments
   24. Internal pacing wires
   25. Metal or wire mesh implants
   26. Hearing aid (remove before MRI) aa. Dentures (remove before MRI) bb. Claustrophobia
3. Unable to tolerate inhalation of gas mixture
4. Presence of facial hair that may interfere with the fit of the mask (and unwillingness to shave prior to each MRI)
5. Any changes in medications that may affect CF lung disease in the past 28 days, including any experimental therapies
6. 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.
7. 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.

Where this trial is running

Chapel Hill, North Carolina

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

Study contacts

• Principal investigator: Jennifer L Goralski, MD — UNC Chapel Hill
• Study coordinator: Jennifer L Goralski, MD

Conditions: Cystic Fibrosis, Ventilatory Defect