Functional and Structural Assessment of Endobronchial Valve Recipients Using Dynamic Hyperpolarized Xenon-129 MRI

Launched by XEMED LLC · Jun 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how a special type of MRI, using hyperpolarized xenon-129, can help us learn more about lung function in patients with Chronic Obstructive Pulmonary Disease (COPD) who are receiving endobronchial valve therapy. The goal is to see how well the lungs are working before and after this treatment by looking at how air moves in and out of the lungs and whether the lung tissue is still healthy. This information could help doctors better understand how COPD progresses and how effective this treatment is.

To participate in the study, you need to be an adult with COPD who is scheduled for endobronchial valve therapy. It's important that you are able to cooperate during the study and agree to come back for follow-up visits. Unfortunately, people under 18, those who are pregnant, or individuals with certain medical conditions that might interfere with the MRI can't join the study. If you decide to participate, you will undergo imaging tests before and after your treatment, and the researchers will guide you through the process to ensure you feel comfortable and informed.

Gender

ALL

Eligibility 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.