TERMINATED

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

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Conditions

COPDendobroncial valvehyperpolarized xenonlung MRI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 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 HPXe will potentially lead to be better understand disease progression and treatment mechanism.

Official Title

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

Quick Facts

Study Start:2023-10-20
Study Completion:2025-09-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05433961

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * COPD patients scheduled to receive endobronchial valve therapy
  2. * Patient is conscious, cooperative and agrees to return for scheduled visits and tests
  1. * Patients less than 18 years old
  2. * Patients known to be pregnant - a positive pregnancy test will be used to respectively exclude pregnant patients
  3. * Any known contraindication to MRI examination
  4. * Anyone with an implanted metal device
  5. * Inability to provide informed consent
  6. * A language, communication, cognitive or behavioral impairment that might interfere with fully informed participation in the study.
  7. * History of uncompensated organ failure (i.e. organ failure that is not stabilized through medical intervention), which will be assessed by the PI.
  8. * Homelessness or other unstable living situation
  9. * Active drug or alcohol dependence
  10. * Claustrophobia
  11. * Subjects weighting more than 300 pounds.
  12. * Subjects with chest size larger than the bore of MRI machine from the study.

Contacts and Locations

Principal Investigator

Kevin Ma, MD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Xemed LLC

  • Kevin Ma, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-20
Study Completion Date2025-09-11

Study Record Updates

Study Start Date2023-10-20
Study Completion Date2025-09-11

Terms related to this study

Keywords Provided by Researchers

  • endobroncial valve
  • hyperpolarized xenon
  • lung MRI

Additional Relevant MeSH Terms

  • COPD