Cystic FibrosisNCT06057714
Quantitation and Spatial Registration of Airways Dysfunction With Dynamic 19F MRI in Cystic Fibrosis
An observational study of Cystic Fibrosis and Ventilatory Defect, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cystic Fibrosis, Ventilatory Defect
- What is being tested?
- 19F MRI
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2021to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with cystic fibrosis and stable lung disease at the time of enrollment
Who may be able to join
- 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 join
- 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)
Show all 34Show fewer
- 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
- Unable to tolerate inhalation of gas mixture
- Presence of facial hair that may interfere with the fit of the mask (and unwillingness to shave prior to each MRI)
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Univeristy of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Jennifer L Goralski, MD, 919-445-0331, jennifer_goralski@med.unc.edu
Jennifer L Goralski, MD
About this study
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
- Being tested
- 19F MRI
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
19F MRICombination product
Also called Perfluoropropane (PFP)
Inhalation of a biologically inert contrast gas, perfluoropropane, combined with 19F-tuned MRI with image acquisition at breath-hold and during tidal breathing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: 19F MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ventilation Defect Parameter (VDP) over 14 days
VDP measured at Day 1 and Day 14, expressed as a percentage of total lung volume
Measured: Day 1 to Day 14
Change in VDP over 365 days
Average of VDP measured at Day 1 and Day 14; subtracted from VDP at Day 365, expressed as a percentage of total lung volume
Measured: Day 1 to Day 365 (+/- 30 days)
Change in FLVlongtau2 over 14 days
FLVlongtau2 measured at Day 1 and Day 14, expressed as a percentage of total lung volume
Measured: Day 1 to Day 14
Change in FLVlongtau2 over 365 days
Average of FLVlongtau2 measured at Day 1 and Day 14; subtracted from FLVlongtau2 at Day 365, expressed as a percentage of total lung volume
Measured: Day 1 to Day 365 (+/- 30 days)
Change in VDP occurring with a protocol-defined CF pulmonary exacerbation
Difference in VDP between baseline and exacerbation visit 1, expressed as a percentage of total lung volume.
Measured: Day 1 to Day 365 (+/- 30 days)
Change in FLVlongtau2 occurring with a protocol-defined CF pulmonary exacerbation
Difference in FLVlongtau2 between baseline and exacerbation visit 1, expressed as a percentage of total lung volume.
Measured: Day 1 to Day 365 (+/- 30 days)
Secondary outcomes (3)
Change in MRI severity score over 365 days
Change in MRI severity score from baseline to Day 365.
Measured: Day 1 to Day 365 (+/- 30 days)
Correlation of MRI severity score with VDP at baseline.
Baseline is a mean of the VDP scores from Day 1 and Day 14 (expressed as percentage of lung).
Correlation of MRI scores with VDP and FLVlongtau2
Measured: Day 1 to Day 14
Correlation of MRI severity score with FLVlongtau2 at baseline.
Baseline is a mean of the FLVlongtau2 scores from Day 1 and Day 14 (expressed as percentage of lung).
Correlation of MRI scores with VDP and FLVlongtau2
Measured: Day 1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start20 Jan 2021
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Jennifer L Goralski, MD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057714
- Sponsor's protocol ID
- 20-1233
- Other IDs
- 5K23HL138257-03
- Status last verified
- Feb 2026
- First submitted
- 18 Sep 2023
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitation and Spatial Registration of Airways Dysfunction With Dynamic 19F MRI in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT06057714
- Acronym / sponsor ID
- 20-1233
- Conditions
- Cystic Fibrosis, Ventilatory Defect
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Cystic Fibrosis Foundation
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Combination Product: 19F MRIAll 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with cystic fibrosis and stable lung disease at the time of enrollment
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (34 listed)
- 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
- Unable to tolerate inhalation of gas mixture
- Presence of facial hair that may interfere with the fit of the mask (and unwillingness to shave prior to each MRI)
- Any changes in medications that may affect CF lung disease in the past 28 days, including any experimental therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 19F MRIAlso: Perfluoropropane (PFP)Inhalation of a biologically inert contrast gas, perfluoropropane, combined with 19F-tuned MRI with image acquisition at breath-hold and during tidal breathing | Combination product | All Participants |
Primary outcome
Change in Ventilation Defect Parameter (VDP) over 14 days
Time frame: Day 1 to Day 14
VDP measured at Day 1 and Day 14, expressed as a percentage of total lung volume
Change in VDP over 365 days
Time frame: Day 1 to Day 365 (+/- 30 days)
Average of VDP measured at Day 1 and Day 14; subtracted from VDP at Day 365, expressed as a percentage of total lung volume
Change in FLVlongtau2 over 14 days
Time frame: Day 1 to Day 14
FLVlongtau2 measured at Day 1 and Day 14, expressed as a percentage of total lung volume
Change in FLVlongtau2 over 365 days
Time frame: Day 1 to Day 365 (+/- 30 days)
Average of FLVlongtau2 measured at Day 1 and Day 14; subtracted from FLVlongtau2 at Day 365, expressed as a percentage of total lung volume
Change in VDP occurring with a protocol-defined CF pulmonary exacerbation
Time frame: Day 1 to Day 365 (+/- 30 days)
Difference in VDP between baseline and exacerbation visit 1, expressed as a percentage of total lung volume.
Change in FLVlongtau2 occurring with a protocol-defined CF pulmonary exacerbation
Time frame: Day 1 to Day 365 (+/- 30 days)
Difference in FLVlongtau2 between baseline and exacerbation visit 1, expressed as a percentage of total lung volume.
3 secondary outcomes
Change in MRI severity score over 365 days
Time frame: Day 1 to Day 365 (+/- 30 days)
Correlation of MRI severity score with VDP at baseline.
Time frame: Day 1 to Day 14
Correlation of MRI severity score with FLVlongtau2 at baseline.
Time frame: Day 1 to Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer L Goralski, MD principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Ventilatory Defect, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer L Goralski, MD (919-445-0331, jennifer_goralski@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ventilation Defect Parameter (VDP) over 14 days (time frame: Day 1 to Day 14). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.