Trial Information

Laser Spectroscopy of Breast Tissue Through a Needle Device

OBJECTIVES:

- To prove that optical spectra collected by inserting an optical fiber probe into breast
tissue through a biopsy needle can be of adequate quality to render a spectroscopic
diagnosis.

OUTLINE: Optical spectra are acquired from ex vivo samples of normal and malignant breast
tissue using diffuse reflectance, fluorescence, and Raman spectroscopy. Tissue spectra are
measured using a portable clinical spectroscopy device with front- and side-viewing optical
fiber probes that are inserted into the breast tissue through a hollow biopsy needle. After
the probes are withdrawn through the needle, cutting biopsies are obtained and the tissue is
marked at the site of the spectral measurements. The biopsy specimens are then fixed in
formalin and submitted for histopathologic studies using standard light microscopy
techniques (i.e., H&E staining and IHC). Additional histochemical, immunohistochemical, and
fluorescent in situ stains may be performed to support the diagnosis or to better understand
the spectroscopy results.

Medical records are reviewed to obtain information from the pathology report on patient
demographics, pathological characteristics of the surgical specimen, and clinical indication
for the surgical procedure.