Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| XePFP2017 | Other Identifier | University of North Carolina at Chapel Hill |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 129Xe MRI | Experimental | 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. |
|
| 19F MRI with PFP | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperpolarized Xenon gas | Drug | Hyperpolarized Xenon gas
|
| Measure | Description | Time Frame |
|---|---|---|
| Volume of unventilated lung area after a single 129Xe inhalation and after each inhalation cycle with PFP | Primary comparison will be the VDP with Xenon (single breath) and after first PFP inhalation cycle (3 breaths of PFP) | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Signal-to-noise (SNR) of each modality | Assessment of the quality of signal achieved with each modality | 20 minutes |
| Rate constant describing wash-in and wash-out of PFP | change in ventilated areas of the lung over time when administered PFP |
Not provided
Inclusion Criteria:
Subjects with CF must meet all of the following inclusion criteria to be eligible for enrollment:
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
Unable to tolerate inhalation of gas mixture
Any changes in medications that may affect CF lung disease in the past 14 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 MRI scan, prior to the MRI scan.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Goralski, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32770779 | Background | McCallister A, Chung SH, Antonacci M, Z Powell M, Ceppe AS, Donaldson SH, Lee YZ, Branca RT, Goralski JL. Comparison of single breath hyperpolarized 129 Xe MRI with dynamic 19 F MRI in cystic fibrosis lung disease. Magn Reson Med. 2021 Feb;85(2):1028-1038. doi: 10.1002/mrm.28457. Epub 2020 Aug 8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| PFP | Drug |
|
|
|
| 15 minutes |
| Correlation between VDP identified by each modality and spirometry and Lung Clearance Index (LCI) | Comparison of VDP to two standard metrics of lung function, spirometry and LCI | 2 hours |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |