Discriminating benign from malignant thyroid nodules in real-time using a novel probe with an integrated elastic scattering spectroscopy biopsy syringe

Thesis (M.A.)--Boston UniversityBackground. Thyroid cancer is the most common endocrine malignancy. The current standard of diagnosis, fine needle aspiration biopsy (FNAB) yields indeterminate results for approximately 10–25% of biopsies, necessitating thyroidectomy for diagnosis. Elastic scattering spectroscopy (ESS) is a minimally invasive optical biopsy technique that is sensitive to cellular and subcellular morphological features. We hypothesized that it was feasible to use ESS in vivo to improve our ability to preoperatively differentiate benign from malignant thyroid nodules. Methods. Under an IRB approved protocol, we collected ESS data from patients undergoing thyroid FNAB using our miniaturized integrated ESS/biopsy probe. Spectral findings were compared to cytology. Results. 108 patients enrolled, 5 patients were excluded due to procedural and mechanical issues. Data from 103 patients was submitted for analysis. Initial evaluation of spectra data demonstrates adequacy and comparability of the miniaturized probe to the prior full-size ESS fiber construct. Conclusion. Performing a clinical trial using a miniaturized integrated ESS/biopsy probe in vivo is feasible and acceptable to patients. Both spectral data and cytologic material are adequate in the majority of patients. With further accrual and analysis, this ESS device may provide cost-effective, real-time, and operator independent assessment of thyroid nodules