Recruiting

Observational Study

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06057714

Conditions

Cystic Fibrosis

Ventilatory Defect

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

19F MRI

Study Details

Brief 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 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

Cystic Fibrosis

Ventilatory Defect

Study ID

NCT06057714

Start date

Jan 20, 2021

Status verified date

Feb, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

19F MRI

Inhalation of a biologically inert contrast gas, perfluoropropane, combined with 19F-tuned MRI with image acquisition at breath-hold and during tidal breathing

Primary outcome measure

  • Change in Ventilation Defect Parameter (VDP) over 14 days [ Time Frame: Day 1 to Day 14 ]
  • Change in VDP over 365 days [ Time Frame: Day 1 to Day 365 (+/- 30 days) ]
  • Change in FLVlongtau2 over 14 days [ Time Frame: Day 1 to Day 14 ]
  • Change in FLVlongtau2 over 365 days [ Time Frame: Day 1 to Day 365 (+/- 30 days) ]
  • Change in VDP occurring with a protocol-defined CF pulmonary exacerbation [ Time Frame: Day 1 to Day 365 (+/- 30 days) ]
  • Change in FLVlongtau2 occurring with a protocol-defined CF pulmonary exacerbation [ Time Frame: Day 1 to Day 365 (+/- 30 days) ]

Central Contacts and Locations

Central contacts

Jennifer L Goralski, MD

919-445-0331jennifer_goralski@med.unc.edu

Margret Z Powell, BS

984-974-2962margret_powell@med.unc.edu

Locations

Univeristy of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Jennifer L Goralski, MD

919-445-0331jennifer_goralski@med.unc.edu

Principal Investigator:

Jennifer L Goralski, MD

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Jul 2, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-07-02.