Clinical Trial Details

Primary Objective:

• To develop an integrated solution to assess breast and ovarian margins using FIBI imaging and AI-based tumor detection models that demonstrate concordance with standard H&E margin evaluation at a confidence interval (CI) of over 95%.

Secondary Objectives:

• To Use FIBI technology with AI-based tumor detection, grossing, staining, imaging, and pathologist evaluation of a lumpectomy specimen can be completed within 15 minutes.

• To show that this approach can eliminate the need for at least 50% of required BCS/lumpectomy revision procedures with few or no ?false positives? that would otherwise result in unnecessary breast tissue excision. In addition to assessing breast lumpectomy tissue, ovarian cancers will be evaluated similarly.