Comparison of 129Xe MRI With 19F MRI in CF Lung Disease
Overview
- Phase
- Early Phase 1
- Intervention
- Hyperpolarized Xenon gas
- Conditions
- Cystic Fibrosis
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Volume of unventilated lung area after a single 129Xe inhalation and after each inhalation cycle with PFP
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study is designed to compare the capabilities of two novel imaging techniques: polarized perfluorinated gas mixed with oxygen, and hyperpolarized xenon mixed with N2 to detect changes in lung ventilation using MRI.
Detailed Description
The goal of this study is to compare the capabilities of two novel imaging techniques: conventional 'thermally' polarized perfluorinated gases (perfluoropropane, or PFP) mixed with oxygen, and hyperpolarized xenon (129Xe) mixed with N2 to detect changes in lung ventilation using magnetic resonance imaging (MRI). Although considerable work has been done internationally with hyperpolarized xenon MRI, the low availability and high cost of this technique is limiting. Perfluorinated gas MRI is an alternative that may in fact be a suitable, simpler alternative. PFP is commercially availability in large quantities, which allows multiple breath studies and thus provides the ability to analyze gas wash-in and wash-out kinetics. These endpoints may improve the investigators ability to detect ventilation abnormalities beyond the traditional "ventilation defect percentage" parameter obtained with 129Xe MRI. The commercial availability of PFP and lack of need for onsite hyperpolarization may also facilitate the transfer of this technology to other centers for the conduct of multicenter studies. The investigators hypothesize that 19F MRI will not be inferior to hyperpolarized xenon MRI in detection of ventilation defect percentages (VDP).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects with CF must meet all of the following inclusion criteria to be eligible for enrollment:
- •Subjects must be at least 18 years of age;
- •Non-smokers (\<10 pack year history and no active smoking in the past year);
- •Diagnosis of cystic fibrosis as via standard sweat chloride/phenotypic features/genotyping
- •Stable lung disease as evidenced by no change in respiratory medications or change in forced expiratory volume in 1 second (FEV1) of \>15% from baseline over the preceding 4 weeks prior to enrollment
- •Baseline FEV1 \>70% of predicted.
- •No use of supplemental oxygen
- •Evidence of a personally signed and dated informed consent document 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.
- •Subjects without CF must meet all of the following inclusion criteria to be eligible for enrollment:
Exclusion Criteria
- •Active or past smokers with less than 1 years since quitting or \>10 pack-year smoking history
- •Co-existent asthma (as evidenced by either clinical diagnosis, chronic oral steroid use, or marked broncho-reactivity on pulmonary function testing)
- •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, grinder;
- •Injury to the eye involving a metallic object
- •Injury to the body by a metallic object (bullet, BB, shrapnel)
- •Presence of a cardiac pacemaker or defibrillator
- •Presence of aneurysm clips
- •Presence of carotid artery vascular clamp
- •Presence of neurostimulator
Arms & Interventions
129Xe MRI
Participants will self-administer hyperpolarized xenon gas via inhalation prior to the investigators acquiring MRI images. MRI imaging will be taken during approximately 15-second breath-holds. After the MRI is complete, participant performs spirometry maneuvers in a room outside the magnet. Once a minimum of 15 minutes has elapsed since leaving the MRI scanner, the participant will return to the MRI scanner, where the second phase of the study will occur. 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.
Intervention: Hyperpolarized Xenon gas
129Xe MRI
Participants will self-administer hyperpolarized xenon gas via inhalation prior to the investigators acquiring MRI images. MRI imaging will be taken during approximately 15-second breath-holds. After the MRI is complete, participant performs spirometry maneuvers in a room outside the magnet. Once a minimum of 15 minutes has elapsed since leaving the MRI scanner, the participant will return to the MRI scanner, where the second phase of the study will occur. 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.
Intervention: PFP
19F MRI with PFP
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. After the MRI is complete, participant performs spirometry maneuvers in a room outside the magnet. Once a minimum of 15 minutes has elapsed since leaving the MRI scanner, the participant returns to the MRI scanner, where he/she will self-administer hyperpolarized xenon gas prior to acquiring MRI images. MRI imaging will be taken during approximately 15-second breath-holds.
Intervention: Hyperpolarized Xenon gas
19F MRI with PFP
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. After the MRI is complete, participant performs spirometry maneuvers in a room outside the magnet. Once a minimum of 15 minutes has elapsed since leaving the MRI scanner, the participant returns to the MRI scanner, where he/she will self-administer hyperpolarized xenon gas prior to acquiring MRI images. MRI imaging will be taken during approximately 15-second breath-holds.
Intervention: PFP
Outcomes
Primary Outcomes
Volume of unventilated lung area after a single 129Xe inhalation and after each inhalation cycle with PFP
Time Frame: 1 hour
Primary comparison will be the VDP with Xenon (single breath) and after first PFP inhalation cycle (3 breaths of PFP)
Secondary Outcomes
- Rate constant describing wash-in and wash-out of PFP(15 minutes)
- Signal-to-noise (SNR) of each modality(20 minutes)
- Correlation between VDP identified by each modality and spirometry and Lung Clearance Index (LCI)(2 hours)