Trial Information

Spectroscopy of Breast Tissue

OBJECTIVES:

Primary

- To determine whether laser spectroscopy of breast tissue performed ex vivo can
effectively distinguish between benign and malignant breast tumors in women undergoing
needle biopsy or surgical excision of a breast lesion identified clinically.

OUTLINE: Patients undergo tissue sample collection via needle biopsy or surgical excision of
a breast lesion. A radiogram of the sample may be obtained to identify target areas for
spectroscopic evaluation. The freshly excised breast tissue samples are analyzed ex vivo by
fluorescence, reflectance, and/or Raman spectroscopy. After completion of the spectroscopic
examination, the tissue samples are submitted for diagnostic pathologic evaluation.
Hematoxylin and eosin stained sections of the tissue samples are examined by light
microscopy for histopathological analysis. The results of the pathological examination are
then compared with the spectroscopic findings and radiological findings (if the biopsy was
performed for a suspect lesion on mammography) to determine if any correlation can be
established and which spectroscopic technique provides the most useful diagnostic
information. Additional histochemical, immunohistochemical, and fluorescence in situ stains
may be performed to support the diagnosis or to better understand the spectroscopy results.

Patients' medical charts are reviewed to obtain clinical information (e.g., age, sex, and
race; results of pathology reports and reports of ancillary studies, including estrogen
receptor, progesterone receptor, and HER-2 receptor testing, for the surgical specimen being
studied and for any other related surgical specimens; menstrual status and date of last
menstrual period; clinical history of breast mass or abnormal mammogram and related
mammography report; clinical history of hormone replacement therapy, birth control pills, or
oophorectomy; and clinical history of chemotherapy or other adjuvant therapy for breast
cancer).