Status:
TERMINATED
Functional and Structural Assessment of Endobronchial Valve Recipients Using Dynamic Hyperpolarized Xenon-129 MRI
Lead Sponsor:
Xemed LLC
Collaborating Sponsors:
University of Pennsylvania
Conditions:
COPD
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
This study proposes 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 clinica...
Detailed Description
This study will be assessing the pulmonary function of COPD patients receiving endobronchial valve (EBV) therapy as part of their clinical care by using HP 129Xe MRI in an effort to evaluate the imagi...
Eligibility Criteria
Inclusion
- COPD patients scheduled to receive endobronchial valve therapy
- Patient is conscious, cooperative and agrees to return for scheduled visits and tests
Exclusion
- 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.
Key Trial Info
Start Date :
October 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2025
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05433961
Start Date
October 20 2023
End Date
September 11 2025
Last Update
September 30 2025
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104