Analysis of data obtained in clinical trials of optical biopsy system for breast cancer diagnostics

摘要

In the clinical trials it was shown, that characteristics of optical scattering and absorption are sensitive to the tissue type and state. In the given report improved optical biopsy system will be presented, clinical trials of which have been conducted in the Regional Oncology Center of Nizhny Novgorod, Russia. During a year more than 160 patients with breast tumors were investigated using this system. Radiation from a xenon lamp through an optical fiber placed inside the probe's needle was delivered into the breast. The radiation scattered from the breast tissue was collected by another fibers also placed in the same needle and its spectrum was measured. Obtained optical data was analyzed to find general optical characteristics of scattered radiation in different types of tissue and revealing the major peculiarities in the spectral scattering coefficients of malignant tumors and their distinctions from benign tumors and healthy tissue. Using different mathematical algorithm the typical template of scattering spectrum was found for benign and malignant type of breast tumor. Then the algorithm of automatic detection of malignant spectra in the data flow was developed. Using this algorithm the datasets of all patients were processed and analyzed and the diagnoses were obtained. The automatic diagnoses were compared with those given by physicians. As a result the indexes of sensitivity and specificity for the optical biopsy diagnostic method were found equal to 96% and 80% correspondingly.