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We present a benchmark pilot study in which high-resolution Full-FieldOptical Coherence Tomography (FF-OCT) is used to image human breast tissue andis evaluated to assess its ability to aid the pathologist's management ofintra-operative diagnoses. Our aim included evaluating the safety of FF-OCT onhuman tissue and determining the concordance between the images obtained withroutinely prepared histopathological material. The compact device used for thisstudy provides a 2 {\mu}m-lateral and a 1 {\mu}m-axial resolution, and is ableto scan a 1.5cm^2 specimen in about 7 minutes. 75 breast specimens obtainedfrom 22 patients have been imaged. Because the contrast in the images isgenerated by endogenous tissue components, no biological, contrast agents orspecimen preparation is required. We characterized the major architecturalfeatures and tissue structures of benign breast tissue, including adipocytes,fibrous stroma, lobules and ducts. We subsequently characterized featuresresulting from their pathological modification and developed a decision treefor diagnosis. Two breast pathologists applied these criteria, resulting in ademonstrable ability to distinguish between normal or benign tissue, in situand invasive carcinomas using FF-OCT images, with a sensitivity of 97% and 90%,respectively, and specificity of 74% and 77% respectfully. FF-OCT shows greatpotential for the evaluation of human tissue and its characterization asnormal/benign vs. lesional, for numerous ex-vivo clinical use-cases. Its highimaging accuracy for in-situ and invasive carcinoma paves the way forapplications where a fast architectural assessment could improve the coreneedle biopsy workflow, tumor margin assessments, and provides qualityassurance for tissue acquired for clinical care and research.

Large Field, High Resolution Full Field Optical Coherence Tomography: A Pre-clinical study of human breast tissue and cancer assessment