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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HL138257-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 19F MRI | Combination Product | Inhalation of a biologically inert contrast gas, perfluoropropane, combined with 19F-tuned MRI with image acquisition at breath-hold and during tidal breathing. |
| Measure | Description | Time Frame |
|---|---|---|
| Participation rate | The number of eligible participants approached for the study divided by the number who consent to participate. | 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. | through study completion, recruitment for 2 years |
| Parental acceptability score | Acceptability questionnaire for guardian; 2 questions, each on a 10 point Likert scale
| Day 1, assessed at single visit |
| Child acceptability score | Acceptability questionnaire for participant; 2 questions, each on a 10 point Likert scale
| Day 1, assessed at single visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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
Pregnancy
Changes in medication that may affect CF lung disease or lung function in the past 28 days, including experimental therapies
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer L Goralski, MD | Contact | 919-445-0331 | jennifer_goralski@med.unc.edu | |
| Caroline Flowers, BS | Contact | 984-974-2962 | caroline_flowers@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer L Goralski, MD | UNC Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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) | 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) | 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) | Day 1, assessed at single visit |