Using MRI to assess lung function in transplant patients
Assessment of Chronic Lung Allograft Dysfunction Using Single-breath & Multi-breath Hyperpolarized Xenon-129 MRI
This study is testing how well a special MRI can show lung function in lung transplant patients and others to see if it helps spot early signs of lung problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Xemed LLC Industry-sponsored |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04941573 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates lung functionality in 90 volunteers using hyperpolarized xenon-129 MRI. The study includes 70 lung transplant recipients, 10 healthy controls, and 10 patients with chronic obstructive pulmonary disease (COPD). Participants will undergo imaging sessions at various post-transplant time points to assess early signs of chronic lung allograft dysfunction (CLAD) and graft acceptance. The study aims to provide insights into lung health by analyzing how well air is replaced during breathing and the condition of lung tissue.
Who should consider this trial
Good fit: Ideal candidates include lung transplant recipients over 18 years old receiving follow-up care at the Hospital of the University of Pennsylvania or Temple University Hospital.
Not a fit: Patients who have not undergone lung transplantation or are under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and early detection of lung transplant rejection, enhancing patient outcomes.
How similar studies have performed: Other studies using hyperpolarized gas MRI have shown promise in assessing lung function, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
General Inclusion Criteria: * For transplant recipients: the subject is a lung transplant recipient who is over 18 years of age, underwent lung transplantation at the Hospital of the University of Pennsylvania or Temple University Hospital, and is receiving follow up care from the Penn or Temple Lung Transplantation teams following said transplant. Written informed consent will be obtained and documented after the subject receives oral and written information about the study. * For diagnosed CLAD patients: the subject is a lung transplant recipient who is over 18 years of age, underwent lung transplantation at the Hospital of the University of Pennsylvania or Temple University Hospital, and has recently received a clinical diagnosis of CLAD. Written informed consent will be obtained and documented after the subject receives oral and written information about the study. * For non-transplant COPD patients: the subject is over 18 years old, has been diagnosed with chronic obstructive pulmonary disease, and has never received a lung transplant. * For healthy controls: the subject is over 18 years of age. 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: Maxim Itkin, MD — University of Pennsylvania
- Study coordinator: Jane Park
- Email: jane.park@pennmeidicine.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.