FNA Tools for ESS: Clinical Application to Thyroid Cancer

Photo of Irving BigioIrving Bigio, Ph.D.coulter_FNA
Professor – Biomedical Engineering
Professor – Electrical and Computer Engineering
Boston University – College of Engineering

 

Jennifer Rosen, M.D.
Assistant Professor – Medicine
Boston University School of Medicine – Surgery

 

Thyroid cancer is the most common endocrine malignancy. Nearly 49% of the rising incidence consisted of cancers measuring 1 cm or smaller and 87% consisted of cancers measuring 2 cm or smaller. The standard of care in the management of a patient with a thyroid nodule is fine-needle aspiration biopsy (FNA) with cytological evaluation.  The American Thyroid Association, as well as most endocrinologists and endocrine surgeons, recommend near-total or total thyroidectomy for well-differentiated thyroid cancer. An accessible, easy-to-use and more accurate diagnostic adjunct to FNA would provide significant patient benefits, eliminating a majority of surgeries for benign conditions and enabling cost savings for the healthcare system.

OBJECTIVE: To develop and clinically test a disposable tool that integrates an ESS fiberoptic probe into an FNA needle to be used in patients with thyroid nodules. The improved diagnostic accuracy, compared to FNA/cytology alone, will significantly reduce the number of unnecessary surgical thyroidectomies, reducing the incidence of patient morbidity and enabling significant costsavings for the healthcare system.

Noninvasive optical tissue diagnosis, often called “optical biopsy,” utilizing various types of optical spectroscopy, and typically mediated by optical fibers, has become a major component of the growing field of biomedical optics. ESS (a method of elastic-scattering spectroscopy developed by the BU group) is a point spectroscopic measurement technique, which, when performed using appropriate fiberoptic geometry, is sensitive to the micro-morphological changes at the cellular and sub-cellular level. The ESS method senses intra-cellular morphology changes in a semi-quantitative manner, to make a diagnosis.  ESS is optimal for use in the small-volume area as found in thyroid nodules, and will not be susceptible to the problem of poor yields of cells, as often happens with FNA, since ESS measurements are made in situ in the tissue. Another advantage of ESS is that it provides an objective and quantitative assessment of tissue pathology that does not require on-site special expertise or subjective image interpretation as in conventional histopathology. ESS is also convenient: the control unit used is lightweight and mobile, and the ESS probe will be designed to fit through a conventional  needles used to perform ultrasound-guided thyroid FNAs.

coulter_FNA2

Biomedical Optics Lab