Clinical Trial: Using MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary Fibrosis

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

Official Title: Using MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary Fibrosis

Brief Summary:

The purpose of this study is to determine whether magnetic resonance imaging (MRI) using inhaled hyperpolarized 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 types of MRI may provide a better way to look at lung structure and function in patients with IPF. The ultimate goal is to predict how a particular patient might respond to a particular therapy and to observe such responses earlier than conventional tests. The investigators anticipate that the images acquired in this study 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 being tested in research studies like this one. In addition, standard MRI with contrast is not typically done as standard of care for monitoring progression of IPF, therefore, its use in this study is also considered investigational.

Healthy volunteers are being asked to participate in this study because the investigators need to develop a database of functional images that are representative of healthy lungs.


Detailed Summary:
Sponsor: Bastiaan Driehuys

Current Primary Outcome: Change in lung function as measured by ventilation defect percentage (VDP) [ Time Frame: 12 months ]

We expect that 129Xe ventilation defect percentage, and 129Xe ventilated lung volume measured 3 months after baseline, will predict CT progression observed 12 months from baseline


Original Primary Outcome: Same as current

Current Secondary Outcome: Change in lung function as measured by gas exchange defect percentage (EDP) [ Time Frame: 12 months ]

Although the study is powered on ventilation defect percentage, we expect regional gas exchange defects to be a more sensitive marker of progression


Original Secondary Outcome: Same as current

Information By: Duke University

Dates:
Date Received: June 16, 2015
Date Started: May 2015
Date Completion:
Last Updated: March 23, 2017
Last Verified: March 2017