Clinical Trial: Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment

Brief 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.


Detailed Summary:
Sponsor: Bastiaan Driehuys

Current Primary Outcome: Change in pulmonary function, as measured by ventilation defect percentage (VDP) [ Time Frame: Baseline, following RT (up to 12 weeks) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in gas exchange defect percentage (EDP) following RT [ Time Frame: Baseline, following RT (up to 12 weeks) ]
    129Xe gas transfer from airspaces to pulmonary blood will be imaged 3 dimensionally. Regions where 129Xe does not transfer to blood are gas exchange defects. Those will be reported by their volume as a fraction of thoracic cavity volume
  • Change in perfusion defect percentage (PDP) following RT [ Time Frame: Baseline, following RT (up to 12 weeks) ]
  • RBC:barrier ratio [ Time Frame: Baseline, following RT (up to 12 weeks) ]


Original Secondary Outcome: Same as current

Information By: Duke University

Dates:
Date Received: June 16, 2015
Date Started: February 2016
Date Completion:
Last Updated: December 21, 2016
Last Verified: December 2016