Assessment of Chronic Lung Allograft Dysfunction Using Single-breath & Multi-breath Hyperpolarized Xenon-129 MRI

Launched by XEMED LLC · Jun 25, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new way to look at lung transplant health in children and young adults. The researchers want to find out if a special type of MRI, using safe gases like helium and xenon, can help detect a serious complication called chronic lung allograft dysfunction (CLAD). CLAD can make it difficult for lung transplant recipients to breathe and is a leading cause of health problems after transplant. This new method could provide clearer images of the lungs without using radiation, which is important since radiation can increase cancer risk.

To participate in this study, you need to be between the ages of 8 and 20 and have a history of lung transplant. You'll also need to have certain lung function tests done before enrolling. If you have any metal implants or devices in your body that could interfere with the MRI, or if you have severe claustrophobia, you might not be eligible. If you join the study, you can expect to undergo MRI scans that use these special gases to help doctors better understand your lung health. This research could lead to improved monitoring of lung transplant patients and potentially better outcomes in the future.

Gender

ALL

Eligibility 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