Assessing lung function in COPD patients using advanced MRI techniques
Functional and Structural Assessment of Endobronchial Valve Recipients Using Dynamic Hyperpolarized Xenon-129 MRI
This study is testing a new MRI technique to see how well the lungs of COPD patients are working before and after they receive endobronchial valve therapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Xemed LLC Industry-sponsored |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05433961 on ClinicalTrials.gov |
What this trial studies
This study evaluates the lung function of COPD patients receiving endobronchial valve therapy through hyperpolarized xenon-129 MRI. Patients will undergo imaging sessions before and after the therapy to assess changes in lung functionality and structure. The study aims to enhance understanding of disease progression and treatment mechanisms by analyzing how well the lungs are functioning and their structural integrity. Participants will be recruited from those scheduled for EBV therapy as part of their standard clinical care.
Who should consider this trial
Good fit: Ideal candidates are COPD patients who are scheduled to receive endobronchial valve therapy.
Not a fit: Patients under 18, pregnant, or with contraindications to MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and treatment strategies for COPD patients.
How similar studies have performed: Similar studies using advanced imaging techniques have shown promise in assessing lung function, but this specific approach with hyperpolarized xenon-129 MRI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * COPD patients scheduled to receive endobronchial valve therapy * Patient is conscious, cooperative and agrees to return for scheduled visits and tests Exclusion Criteria: * Patients less than 18 years old * Patients known to be pregnant - a positive pregnancy test will be used to respectively exclude pregnant patients * Any known contraindication to MRI examination * Anyone with an implanted metal device * Inability to provide informed consent * A language, communication, cognitive or behavioral impairment that might interfere with fully informed participation in the study. * History of uncompensated organ failure (i.e. organ failure that is not stabilized through medical intervention), which will be assessed by the PI. * Homelessness or other unstable living situation * Active drug or alcohol dependence * Claustrophobia * Subjects weighting more than 300 pounds. * Subjects with chest size larger than the bore of MRI machine from the study.
Where this trial is running
Philadelphia, Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Kevin Ma, MD — University of Pennsylvania
- Study coordinator: Jane Park
- Email: jane.park@pennmedicine.upenn.edu
- Phone: 215-349-8553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.