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

• Status: Not yet recruiting
• Trial end date: 2027-07-31
• Target enrollment: 0
• Participant gender: All

Summary

We propose to use hyperpolarized xenon-129 Magnetic Resonance Imaging (MRI) to study lung function of COPD patients who will receive endobronchial valve (EBV) therapy as part of their clinical standard-of-care. Once inhaled, HP xenon can provide information to imagers regarding functionality across specific regions of the lungs through the assessment of the replacement of air during the normal breathing cycle, how much oxygen is in the airspaces, and if the normal spongy tissue structure has been compromised by lung disease. Pre- (baseline) and post-EBV (follow-up) lung function imaging with HP Xe will potentially lead to be better understand disease progression and treatment mechanism.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xemed LLC
• Collaborator: University of Pennsylvania
• Treatments: Xenon

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.