This study compares the equivalence of hyperpolarized 129Xe MRI to 133Xe scintigraphy for the evaluation of pulmonary function in patients being evaluated for lung transplant.
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 transplant surgery (either single or bilateral) . 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
48
Evaluation of pulmonary function
Evaluation of pulmonary function
Duke University Hospital
Durham, North Carolina, United States
University of Virginia
Charlottesville, Virginia, United States
Right lung function
Scan predicted contribution of right lung to overall lung function
Time frame: 48 hours
6 zone analysis
The percentage function contributed by each of the individual 6 lung zones.
Time frame: 48 hours
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