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Discriminating Thyroid Nodules in Real Time Using an Integrated Elastic Scattering Biopsy Syringe
*Nicholas J. Giordano, *Eladio Rodriguez-Diaz, *Ousama A'amar, *Irving J. Bigio, *Stephanie L. Lee, Jennifer E. Rosen
Boston University, Boston, MA

OBJECTIVE: Thyroid cancer is the most common endocrine malignancy. The criterion standard for diagnosis, fine-needle aspiration (FNA) biopsy, yields approximately 10-25% of indeterminate results leading to patients undergoing thyroidectomy for diagnosis. Elastic scattering spectroscopy (ESS) is a new, minimally invasive optical-biopsy technique mediated by fiber-optic probes that is sensitive to cellular and subcellular morphological features. Currently, there is no definitive preoperative way to determine whether a thyroid nodule is benign or malignant when cytology yields an indeterminate result. We assessed the potential to incorporate ESS into a 23 gauge needle biopsy to use in a preoperative transcutaneous biopsy of the thyroid to differentiate benign from malignant thyroid nodules.

DESIGN: We designed and built a miniaturized ESS probe that can fit through a 23 gauge needle biopsy and tested it under an IRB approved protocol on patients undergoing a thyroid biopsy. We used final surgical pathology as our criterion standard.

SETTING: Referral center - endocrinology clinic.

PARTICIPANTS: Subjects were of both genders, ranging from ages 23-84 years old, of all ethnic groups speaking English, or Spanish. No children were included in the study. Only patients already undergoing a biopsy for clinical purposes underwent optical biopsy at the same time as their physical biopsy. 115 patients were assessed for eligibility into the study, 3 declined to participate and 112 enrolled in the study. Accrual continues for the study at the time of this publication..

MAIN OUTCOME MEASURES: We want to analyze the ESS spectra collected from benign and malignant thyroid tissues.

RESULTS: 112 patients were enrolled, 5 patients were excluded due to procedural and mechanical issues. Preliminary data suggests that there is a unique ESS optical signature, especially at the regions of ultraviolet light, which corresponds to benign and malignant thyroid tissue.

CONCLUSIONS: The data suggests that there is a unique ESS optical signature which corresponds to benign and malignant thyroid tissue. Additional benefits of the real time feedback that ESS provides are that it is capable of detecting the contents of a thyroid nodule, including but not limited to cystic fluid, micro and macro calcifications, and hemoglobin content. This data from ESS carries the potential to reduce the amount of diagnostic surgeries done for the most common endocrine malignancy, thyroid cancer. This could potentially increase the quality of life for patients found to have a thyroid nodule, and address an unmet clinical need.

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