19F MRI of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary Exacerbation
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|ClinicalTrials.gov Identifier: NCT03497117|
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : April 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Device: Lung Clearance Index Drug: MRI with PFP||Early Phase 1|
The investigators hypothesize that 19F-enhanced MRI will detect improvements in lung ventilation following the treatment of a CF pulmonary exacerbation, and changes in ventilation as well as global MRI scores will track with both spirometry and quality of life assessments. Therefore, investigators propose this pilot and feasibility study to gain preliminary data on a comparison of the changes in ventilation that occur with treatment of a pulmonary exacerbation, as well as to begin to understand the repeatability of this novel outcome measure. Through this study, the investigators aim to: 1) Compare quantitative and qualitative assessments of lung ventilation using 19F MRI imaging and traditional, global physiologic assessments (spirometry, LCI) and compare these with images obtained in an age-matched healthy control population; 2) Correlate changes in MRI scoring with subjective changes in health related outcomes as measured by the CFQ-R (Cystic Fibrosis Questionnaire - Revised); 3) Determine the ability of 19F MRI to detect changes in ventilation that occur with treatment of a CF pulmonary exacerbation; and 4) Determine the repeatability of 19F MRI assessment of ventilation in a disease population.
Participants with CF with baseline forced expiratory volume in 1 second (FEV1) of at least 40%, no contraindications to MRI, and oxygen saturation >90% on room air will be prospectively enrolled. Investigators will recruit a pre-defined cross-section of CF patients with mild, moderate, and severe lung disease, with approximately 4 subjects per group at the onset of a disease exacerbation requiring antibiotic intervention. The research team will obtain a pre-response MRI (within 3 days of initiating oral, inhaled, or IV antibiotic therapy), and a post-treatment MRI (within 3 days of terminating antibiotic treatment) to assess the responsiveness of 19F-MRI to a change in disease status. Each 19F-MRI study will be combined with assessments of spirometry, LCI (multiple breath nitrogen washout), and quality of life (CFQ-R quality of life tool).
19F-MRI will be performed by having each participant inhale a mixture of 79% perfluorinated propane (PFP) and 21% oxygen (pre-mixed) while using MRI to obtain 3D images. Subsequently, participants will be switched to room air, and cycled breathing will be continued while additional MRI images are captured to characterize gas wash-out. Safety measures, including pulse oximetry, will be monitored continuously, and spirometry will be performed before and after each MRI. Participants will also perform multiple breath washout maneuvers to obtain a lung clearance index, so this may be correlated to wash-out kinetics of the PFP.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Participants undergoing treatment for a pulmonary exacerbation will perform multiple breath washout and undergo an MRI with inhalation of a gas contrast agent (79% perfluorppropane (PFP) mixed with 21% oxygen) at the beginning and end of treatment.|
|Masking:||None (Open Label)|
|Official Title:||19F Magnetic Resonance Imaging of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary Exacerbation|
|Actual Study Start Date :||August 25, 2015|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||December 1, 2020|
CF pulmonary exacerbation group
Patients with cystic fibrosis being treated for a pulmonary exacerbation will undergo Lung Clearance Index (LCI) and an MRI with PFP.
LCI testing will take place before the MRI. Each test will take 5-20 minutes and up to three tests will be performed with at least 5-minute rest periods between each test.
PFP gas will be administered using a full-face mask during the MRI. Images are acquired during 12-second breath-hold after every 3rd breath. Before and after the MRI is complete, participants will perform spirometry maneuvers in a room outside of the magnet.
Device: Lung Clearance Index
To assess the efficiency of ventilation distribution and gas mixing by measuring the rate of clearance of an inert gas (nitrogen) from the lungs.
Other Name: LCI
Drug: MRI with PFP
Other Name: Perfluoropropane gas (C3F8); 19F
- Whole lung ventilation defect volume (VDV) [ Time Frame: 1 day ]To obtain ventilation defect volumes (VDVs), investigators will use the final wash-in image to identify all regions of interest having a signal intensity below the pre-defined threshold which indicates poor ventilation. The combined volume of all these 'ventilation defect' regions will be computed to obtain the VDV.
- The wash-in kinetics of PFP [ Time Frame: 1 day ]For each participant, an exponential model will be fit to obtain a statistical estimate, T, of the rate constant that characterizes the kinetics of gas wash-in. Aggregating across all participants, the frequency distributions of T values will be characterized by tabulating estimates of the mean and standard deviation (SD). Corresponding 95% confidence intervals and the minimum, maximum, and interquartile range of T values will also be tabulated.
- Ventilation defect percent (VDP) correlation with LCI [ Time Frame: 1 day ]Changes in VDP from pre/post treatment will be correlated with changes in LCI pre- and post-exacerbation.
- Ventilation defect percent (VDP) correlation with FEV1 [ Time Frame: 1 day ]Changes in VDP from pre/post treatment will be correlated with changes in FEV1 pre- and post- exacerbation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497117
|Contact: Jennifer L Goralski, MDfirstname.lastname@example.org|
|Contact: Kelsey B Haywood, BSemail@example.com|
|United States, North Carolina|
|University of North Carolina at Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Jennifer L Goralski, MD 919-455-0331 firstname.lastname@example.org|
|Contact: Kelsey B Haywood, BS 919-445-2855 email@example.com|
|Principal Investigator: Jennifer L Goralski, MD|