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Clinical Trial Summary

This study compares the equivalence of hyperpolarized 129Xe MRI as compared to 133Xe scintigraphy for the evaluation of pulmonary function in patients being evaluated for lung resection.


Clinical Trial Description

This is a multicenter, randomized, open-label, cross-over Phase 3 study evaluating hyperpolarized 129Xe gas MRI as compared to 133Xe scintigraphy for the evaluation of pulmonary function. This study will enroll subjects being evaluated for possible lung resection surgery (i.e. segmentectomy, lobectomy, or pneumonectomy). Subjects will have both a 129Xe MRI and 133Xe scintigraphy image. The vast differences in technique for obtaining hyperpolarized 129Xe MRI as compared to 133Xe scintigraphy make it impossible to blind study procedures. However, all image interpretation will be performed by personnel blinded to the subject's medical history and all study assessments. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03417687
Study type Interventional
Source Polarean, Inc.
Contact
Status Completed
Phase Phase 3
Start date August 17, 2018
Completion date March 10, 2020

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