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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
38
Evaluation of pulmonary function
Evaluation of pulmonary function
Duke University Hospital
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
University of Virginia
Charlottesville, Virginia, United States
Predicted Percentage of Remaining Pulmonary Function
Predicted percentage of remaining pulmonary function is a pre-specified section of lung were to be removed. Investigators indicated which portions of lung were likely to be resected. Remaining percentage of pulmonary function was determined by subtracting the percentage of pulmonary function contributed by the planned zone of resection from the total pulmonary function using a standard 6-zone image analysis of the lung. The difference between predicted percentage of remaining pulmonary function was calculated by subtracting the value derived from the 133Xe scintigraphy image from the value derived from the 129Xe MRI image (e.g. 129Xe - 133Xe).
Time frame: 48 hours
Predicted Versus Measured FEV1
The difference between the scan-predicted post-operative FEV1 and the measured post-operative FEV1
Time frame: 3 months
Measured Percentage of Total Ventilation Contributed by the Lower Left Lung Zone.
The fraction of total ventilation contributed by the lower left lung zone on 6-zone analysis.
Time frame: 48 hours
Measured Percentage of Total Ventilation Contributed by the Upper Left Lung Zone.
The fraction of total ventilation contributed by the upper left lung zone on 6-zone analysis.
Time frame: 48 hours
Measured Percentage of Total Ventilation Contributed by the Middle Left Lung Zone.
The fraction of total ventilation contributed by the middle left lung zone on 6-zone analysis.
Time frame: 48 hours
Measured Percentage of Total Ventilation Contributed by the Upper Right Lung Zone.
The fraction of total ventilation contributed by the upper right lung zone on 6-zone analysis.
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Time frame: 48 hours
Measured Percentage of Total Ventilation Contributed by the Middle Right Lung Zone.
The fraction of total ventilation contributed by the middle right lung zone on 6-zone analysis.
Time frame: 48 hours
Measured Percentage of Total Ventilation Contributed by the Lower Right Lung Zone.
The fraction of total ventilation contributed by the lower right lung zone on 6-zone analysis.
Time frame: 48 hours