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Miniaturization Does Not Impair the Ability of ESS to Assess Malignancy in Human Thyroid Nodules
Jennifer E. Rosen, MD1, Nicholas J. Giordano, MD1, Hyunsuk Suh, MD1, Faris Azar, MD1, Eladio Rodriguez-Diaz, MD2, Ousama M. A'Amar, MD2, Irving J. Bigio, MD2, Stephanie L. Lee, MD3
1Department of Surgery, 2Department of Biomedical Engineering 3Department of Medicine, Section of Endocrinology, Diabetes and Nutrition, Boston University School of Medicine, Department of Surgery, Boston, MA

Background: Thyroid nodules are common, but are rarely malignant. The current gold standard for diagnosis, fine-needle aspiration biopsy, yields 10-25% of indeterminate cytology results, leading to patients undergoing thyroidectomy for diagnosis. We assessed the technical potential of a miniature ESS probe that was designed to fit into a 23 gauge FNA needle assembly to differentiate benign from malignant thyroid nodules.

Methods: We collected data in vivo using the miniaturized ESS probe on patients undergoing ultrasound-guided thyroid biopsy. A standard operating protocol (SOP) was created and refined including cleaning and sterilization, physician tool use, calibration and resterilization. Using pathology as our gold standard, spectra from the miniaturized ESS probe were compared to previous ESS data that was collected ex vivo with a larger optical geometry.

Results: 122 patients were enrolled in the in vivo study and results were compared to ESS spectra taken from 64 patients measures with a large, ex vivo probe. ESS features were comparable between both in vivo and ex vivo probes. Measurement acquisition time for the miniaturized in vivo optical probe was under one second.

Conclusion: An in vivo trial of an invasive miniaturized integrated ESS biopsy probe for discrimination of benign from malignant thyroid nodules is feasible and comparable to larger ex vivo probes. Collection of ESS data during a biopsy would be both practical and reliable. Results demonstrated excellent reproducibility. With the development of a disease-specific algorithm, ESS could potentially be used as an in-situ real-time intra-operative diagnostic tool or as a minimally invasive adjunct to conventional FNA cytology.


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