Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment
Condition: Radiation Injury
MeSH terms: Radiation Injuries
Intervention: Hyperpolarized 129-Xenon gas; MRI
Intervention description: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.; Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
Intervention MeSH terms: Xenon
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Radiation induced lung injury; Xenon gas; hyperpolarized

Summary:

      The purpose of this study is to determine whether magnetic resonance imaging (MRI) using
      inhaled hyper polarized xenon-129 (129Xe) gas, and conventional contrast can help visualize
      impaired lung function and detect changes over time in patients receiving treatment as well
      as those who don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be
      able to show areas of abnormal thickening of parts of the lungs. These images combined with
      images taken with injected contrast agents or other special types of MRI such as conventional
      proton (1H) MRI may provide a better way to look at lung structure and function. The ultimate
      goal is to predict the degree of radiation-induced lung injury that will develop in a given
      patient for a given treatment plan. The investigators anticipate that these images will
      provide more specific information about lung disease than standard lung function tests. The
      use of 129Xe MRI is investigational. Investigational means that these tests have not yet been
      approved by the US Food and Drug Administration and are only available in research studies
      like this one. In addition, standard MRI with contrast is not typically done as standard of
      care for monitoring changes due to thoracic radiation therapy, therefore, its use in this
      study is also considered investigational.

      Healthy volunteers are being asked to participate in this study because to develop a database
      of functional images that are representative of healthy lungs.
    

Eligibility criteria:

        Inclusion Criteria for Patients:

          1. Patient scheduled to undergo thoracic RT at Duke University to a dose of at least 20
             Gy

          2. Willing and able to give informed consent and adhere to visit/protocol schedules

        Exclusion Criteria for Patients:

          1. Subject is less than 18 years old

          2. MRI is contraindicated based on responses to MRI Screening questionnaire

          3. Subject is pregnant or lactating

          4. Respiratory illness of a bacterial or viral etiology within 30 days of MRI

          5. Subject has any form of known cardiac arrhythmia

          6. Subject does not fit into 129Xe vest coil used for MRI

          7. Subject cannot hold his/her breath for 15 seconds

          8. Subject deemed unlikely to be able to comply with instructions during imaging

          9. Medical or psychological conditions which, in the opinion of the investigator, might
             create undue risk to the subject or interfere with the subject's ability to comply
             with the protocol requirements

        Inclusion/Exclusion Criteria for Healthy Volunteers

        1. Subject meets all criteria above but does not have a clinical diagnosis of respiratory
        disease.