AIG on sedarwill co. build 4 units for clinical study or will one unit be used at 4 different sites in succession?
Clinical Study Design for FDA Market Authorization
The initial indication for IzoView is intended for diagnostic imaging of the breast for patients with suspicious findings on screening mammography. IzoView is not intended for breast cancer screening for the clinical study designed for the company’s initial market authorization in the U.S. The study design is to compare images acquired on IzoView utilizing contrastenhancement (CE) with an iodinebased contrast agent in comparison to noncontrastenhanced diagnostic mammography. This is a multireader, multicase superiority study. Specifically, readers will assess both diagnostic mammography and CEIzoView breast CT images and their assessment will be compared to the final clinical diagnosis. The subject’s final clinical diagnosis for the study is determined by 1year followup or subsequent histopathology result from a biopsy. Subjects that have a negative finding at 1 year will be classified as having a final diagnosis of “no cancer”. Discovery of a cancer at any time up to and including the first year after initial diagnostic mammography examination resulted in the subject being assigned a final diagnosis of cancer.
Izotropic may have up to four clinical sites in the U.S. with total participant recruitment may take one to two years depending on a variety of factors including, but not limited to, recruitment capability and cancer positivity rate at a site.