Trial Information

Breast Tumor Detection Using Optical Spectroscopy

OBJECTIVES:

- To develop a non-invasive detection tool that evaluates breast tumor margins in
real-time to guide tumor resection during partial mastectomy procedures.

- To conduct an ex vivo optical spectroscopic study in operating rooms on breast tissue
samples obtained immediately following resection to assess the efficacy of using this
tool in differentiating breast tumor or tumor margins from normal breast tissue.

OUTLINE: Breast tissue samples obtained immediately following resection are examined in the
operating room using optical spectroscopy to evaluate the margin tissue. During
spectroscopy, all lights, except for the surgical lights, are turned off and the lateral,
superior, medial, inferior, deep, and anterior margins of the breast tissue sample are
examined using a fiber-optic probe, a nitrogen laser, and a broad band white light source.
Reflectance and fluorescence spectra are measured at each of these margins by a system
operator. The measured margins are then immediately marked by sutures placed by the surgeon.
Additional margins may be measured at the surgeon's and system operator's discretion. The
breast tissue sample is then delivered to surgical pathology, where shave biopsies are
performed at the suture-marked sites to provide a direct correlation between spectroscopy
measurements and tissue pathology.

Data collected in this study, including spectral data, gross diagnosis of the patient's
tumor, and histological identities of all specimens collected, will be kept in the research
record for at least 6 years after the study is finished.