Pilot study for functional and structural MR Imaging of Endobroncial valve recipients using hyperpoloarized XENON-129

  • STATUS
    Recruiting
  • participants needed
    20
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Updated on 19 February 2024

Summary

We propose to use gas Magnetic Resonance Imaging (MRI) using the inhaled contrast agent, hyperpolarized (HP) xenon-129, to study the lungs of 20 volunteers who have received or will receive endobronchial valve (EBV) therapy as a treatment for COPD. Since its recent FDA approval, investigators have yet to explicitly assess the overall affect of this therapy on overall lung functionality. This protocol will assess any potential changes in proper lung structure and functionality by using HP xenon-129 MRI. Once inhaled, this gas can provide information regarding lung structure and functionality, while also providing information regarding the changes that occur in the lung from EBV therapy and the efficacy of the therapy for treating COPD.

Description

If you agree to join the study, you will be asked to complete the following research procedures:
  • Quality of Life Pulmonary Questionnaires:
    o St. Georges Respiratory Questionnaire
    o Modified Medical Research Council Questionnaire o COPD Assessment Test (CAT)
  • Brief physical exam
  • Pulmonary function test (if not completed with your physician prior to
    attending the study)
  • Practice for the breathing procedure being performed during the study
  • MRI scanning using the inhaled MRI contrast agent Hyperpolarized Xenon-
    129 (HP 129Xe)
    Your participation will last for up to two years. Over the course of your participation, you will be contacted to attend up to five follow up visits after your initial baseline visit. 

FAQ


Details
Condition COPD
Age 99years or below
Clinical Study IdentifierTBD
Last Modified on19 February 2024

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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