Lung Diseases Clinical Trial
Official title:
Comparison of 133Xe Scintigraphy With 19F MRI for Evaluation of Lung Ventilation Function: A Non-Inferiority Comparison (DIAL1001007)
The central hypothesis and current observation is that PFx gases used as contrast agents readily provide functional images of the lung airways including important regional ventilation information such as ventilation defect severity and gas trapping. This is a pilot proof of concept study to demonstrate the non-inferiority of 19F MRI gas Ventilation imaging compared to 133Xe ventilation Scintigraphy in subjects with lung disease. The secondary goal of the study is to develop sufficient information to adequately power a pivotal trial of 19F MRI gas Ventilation imaging compared to 133Xe Ventilation Scintigraphy
Aim 1: Compare measures of lung ventilation performance obtained using 133Xe Scintigraphy
with performance using 19F Perfluorinated gas MRI using two independent readers.
133Xe Scintigraphy will be scored using the methods described in the statistics section and
19F images will be scored using the methods described in the statistics section. Scores for
each subject will be earluated for consistency between readers and modalities. 60%
concordance will be considered equivalent.
The outcomes of the work proposed is expected to show the non-inferiority of 19F
Perfluorinated gas MRI to 133Xenon Scintigraphy
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