Cystic Fibrosis in ChildrenNCT06066723
19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease
An observational study of Cystic Fibrosis in Children, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This study capitalizes on the emerging technology of 19F MRI, using conventional 'thermally' polarized perfluorinated gas (perfluoropropane, or PFP) mixed with oxygen and studied with magnetic resonance imaging (MRI) to visualize ventilation. This technique has not been studied in children. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis in Children
- What is being tested?
- 19F MRI
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2025to 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy volunteers between the ages of 6-17 years old without known lung disease OR people with cystic fibrosis between the ages of 6-17 years
Who may be able to join
- 6-17 years old
- Non-smoker and non-vaper
- Cystic Fibrosis (CF) Group: must have a diagnosis of CF
- No use of supplemental oxygen
- They must be able to perform spirometry and have stable lung function (within 10% personal best in the last 6 months) and no exacerbations within the past 4 weeks
- Baseline forced expiratory volume in 1 second (FEV1) >80% with ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lung (FEV1:FVC) ratio >0.7
Who cannot join
- Healthy volunteers: with any history of chronic lung disease (i.e. asthma)
- Active or former smoker with less than 1 year of quitting
- Unable to undergo an MRI of the lungs and chest because of contraindications, including:
- Injury to the eye involving a metallic object
- Injury to the body involving a metallic object
- Presence of an implanted drug infusion device that is not MRI safe
Show all 15Show fewer
- Bone growth of fusion simulator
- Presence of cochlear, otologic, or ear implant
- Shunt (spinal or intraventricular)
- Any implant held in place by magnet
- Claustrophobia
- Unable to tolerate the inhalation of the gas mixture
- Facial hair preventing a tight fit of the mask used in the study
- Pregnancy
- Changes in medication that may affect CF lung disease or lung function in the past 28 days, including experimental therapies
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
University 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
Official title: A Cross-sectional Pilot Study of 19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease
This study capitalizes on the emerging technology of 19F MRI, using conventional 'thermally' polarized perfluorinated gas (perfluoropropane, or PFP) mixed with oxygen and studied with magnetic resonance imaging (MRI) to visualize ventilation. This technique has not been studied in children.
Children and adolescents (6-17 years old) with cystic fibrosis (CF) who have normal spirometry will undergo 19F MRI with the inhalation of an inert contrast gas to study ventilation. Comparisons will be made to a cohort of healthy children (6-17 years old) who will perform the same measures. The primary outcome measure is the feasibility of conducting these studies in the pediatric population. Parallel performance of multiple breath nitrogen washout (MBW) and spirometry will be used to compare the sensitivity of these outcomes to the presence of mild lung disease in these children. Finally, the investigators will compare data obtained during standard breath holds with a novel "free-breathing" technique that will eliminate the need for breath holds during MRI acquisition.
- Conditions
- Cystic Fibrosis in Children
- Being tested
- 19F MRI
- Keywords
- 19F MRI, ventilation, pediatrics
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
19F MRICombination product
Also called 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 |
|---|---|---|
| Children with CF | All subjects to receive inhaled perfluoropropane during MRI procedures, including standard breath hold and free-breathing technique. Subjects will breathe the gas for 5 breath hold cycles (variable volumes as lung capacity/size varies per participant). Receives: Combination Product: 19F MRI | |
| Healthy Children | All subjects to receive inhaled perfluoropropane during MRI procedures, including standard breath hold and free-breathing technique. Subjects will breathe the gas for 5 breath hold cycles (variable volumes as lung capacity/size varies per participant). Receives: Combination Product: 19F MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate
The number of eligible participants approached for the study divided by the number who consent to participate.
Measured: through study completion, recruitment for 2 years
Completion rate
The number of consented participants divided by the number of participants who complete each portion of the study.
Measured: through study completion, recruitment for 2 years
Parental acceptability score
Acceptability questionnaire for guardian; 2 questions, each on a 10 point Likert scale
- Implementation: qualitative description of barriers encountered
- Practicality: % of participants completing the study with research quality data
Measured: Day 1, assessed at single visit
Child acceptability score
Acceptability questionnaire for participant; 2 questions, each on a 10 point Likert scale
- Implementation: qualitative description of barriers encountered
- Practicality: % of participants completing the study with research quality data
Measured: Day 1, assessed at single visit
Secondary outcomes (4)
MRI defined ventilation defect parameters (VDP) in healthy participants
The 19F Volumetric interpolated breath-hold examination (VIBE) scans and proton nuclear magnetic resonance imaging (1H-MRI) will be saved as Digital Imaging and Communications in Medicine (DICOM) images and imported to Medical Image Merge (MIM) software. The percentage of lung with ventilation defects (VDP) after the 5th inspiratory cycle will be measured, using the 95th percentile of background noise on the last wash-in scan as the threshold value defining absence of ventilation. The investigators will assess ventilation defect parameters (VDP) scored in healthy participants (mean + SD)
Measured: Day 1, assessed at single visit
MRI defined fraction of lung volume with slow gas washout time (FLVlongtau2) in healthy participants
The 19F Volumetric interpolated breath-hold examination (VIBE) scans and 1H-MRI will be saved as Digital Imaging and Communications in Medicine (DICOM) images and imported to Medical Image Merge (MIM) software. The fraction of the total lung volume with slow gas wash-out kinetics (FLV↑tau2) will be calculated for lung regions without an overlapping full ventilation defect. The investigators will assess FLVlongtau2 scored in healthy participants (mean + SD)
Measured: Day 1, assessed at single visit
MRI defined VDP in participants with cystic fibrosis
The 19F VIBE scans and 1H-MRI will be saved as Digital Imaging and Communications in Medicine (DICOM) images and imported to Medical Image Merge (MIM) software. The percentage of lung with ventilation defects (VDP) after the 5th inspiratory cycle will be measured, using the 95th percentile of background noise on the last wash-in scan as the threshold value defining absence of ventilation. The investigators will assess ventilation defect parameters (VDP) scored in participants with cystic fibrosis (mean + SD)
Measured: Day 1, assessed at single visit
MRI defined fraction of lung volume with slow gas washout time (FLVlongtau2) in participants with cystic fibrosis
The 19F Volumetric interpolated breath-hold examination (VIBE) scans and 1H-MRI will be saved as Digital Imaging and Communications in Medicine (DICOM) images and imported to Medical Image Merge (MIM) software. The fraction of the total lung volume with slow gas wash-out kinetics (FLV↑tau2) will be calculated for lung regions without an overlapping full ventilation defect. The investigators will assess FLVlongtau2 scored in participants with cystic fibrosis (mean + SD)
Measured: Day 1, assessed at single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start16 Jun 2025
- 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 Fibrosis in ChildrenStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Jennifer L Goralski, MD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066723
- Sponsor's protocol ID
- 23-0700
- Other IDs
- 5K23HL138257-03
- Status last verified
- Feb 2026
- First submitted
- 20 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
- A Cross-sectional Pilot Study of 19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease
- ClinicalTrials.gov ID
- NCT06066723
- Acronym / sponsor ID
- 23-0700
- Conditions
- Cystic Fibrosis in Children
- Keywords
- 19F MRI, ventilation, pediatrics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 4 Oct 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.
This study capitalizes on the emerging technology of 19F MRI, using conventional 'thermally' polarized perfluorinated gas (perfluoropropane, or PFP) mixed with oxygen and studied with magnetic resonance imaging (MRI) to visualize ventilation. This technique has not been studied in children.
Children and adolescents (6-17 years old) with cystic fibrosis (CF) who have normal spirometry will undergo 19F MRI with the inhalation of an inert contrast gas to study ventilation. Comparisons will be made to a cohort of healthy children (6-17 years old) who will perform the same measures. The primary outcome measure is the feasibility of conducting these studies in the pediatric population. Parallel performance of multiple breath nitrogen washout (MBW) and spirometry will be used to compare the sensitivity of these outcomes to the presence of mild lung disease in these children. Finally, the investigators will compare data obtained during standard breath holds with a novel "free-breathing" technique that will eliminate the need for breath holds during MRI acquisition.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with CF | – | Combination Product: 19F MRIAll subjects to receive inhaled perfluoropropane during MRI procedures, including standard breath hold and free-breathing technique. Subjects will breathe the gas for 5 breath hold cycles (variable volumes as lung capacity/size varies per participant). |
| Healthy Children | – | Combination Product: 19F MRIAll subjects to receive inhaled perfluoropropane during MRI procedures, including standard breath hold and free-breathing technique. Subjects will breathe the gas for 5 breath hold cycles (variable volumes as lung capacity/size varies per participant). |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy volunteers between the ages of 6-17 years old without known lung disease OR people with cystic fibrosis between the ages of 6-17 years
Key inclusion criteria (6 listed)
- 6-17 years old
- Non-smoker and non-vaper
- Cystic Fibrosis (CF) Group: must have a diagnosis of CF
- No use of supplemental oxygen
- They must be able to perform spirometry and have stable lung function (within 10% personal best in the last 6 months) and no exacerbations within the past 4 weeks
Key exclusion criteria (15 listed)
- Healthy volunteers: with any history of chronic lung disease (i.e. asthma)
- Active or former smoker with less than 1 year of quitting
- Unable to undergo an MRI of the lungs and chest because of contraindications, including:
- Unable to tolerate the inhalation of the gas mixture
- Facial hair preventing a tight fit of the mask used in the study
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: PFPInhalation of a biologically inert contrast gas, perfluoropropane, combined with 19F-tuned MRI with image acquisition at breath-hold and during tidal breathing. | Combination product | Children with CF, Healthy Children |
Primary outcome
Participation rate
Time frame: through study completion, recruitment for 2 years
The number of eligible participants approached for the study divided by the number who consent to participate.
Completion rate
Time frame: through study completion, recruitment for 2 years
The number of consented participants divided by the number of participants who complete each portion of the study.
Parental acceptability score
Time frame: Day 1, assessed at single visit
Acceptability questionnaire for guardian; 2 questions, each on a 10 point Likert scale * Implementation: qualitative description of barriers encountered * Practicality: % of participants completing the study with research quality data
Child acceptability score
Time frame: Day 1, assessed at single visit
Acceptability questionnaire for participant; 2 questions, each on a 10 point Likert scale * Implementation: qualitative description of barriers encountered * Practicality: % of participants completing the study with research quality data
4 secondary outcomes
MRI defined ventilation defect parameters (VDP) in healthy participants
Time frame: Day 1, assessed at single visit
MRI defined fraction of lung volume with slow gas washout time (FLVlongtau2) in healthy participants
Time frame: Day 1, assessed at single visit
MRI defined VDP in participants with cystic fibrosis
Time frame: Day 1, assessed at single visit
MRI defined fraction of lung volume with slow gas washout time (FLVlongtau2) in participants with cystic fibrosis
Time frame: Day 1, assessed at single visit
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 in Children, 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 6 inclusion and 15 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?
Participation rate (time frame: through study completion, recruitment for 2 years). The study lists 4 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; AzTrials last refreshed its copy on 8 Nov 2026.