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Design, Conduct and Challenges of a Clinical Trial Utilizing Elastic Light Scattering Spectroscopy in vivo for the Diagnosis of Thyroid Nodules
Jennifer E. Rosen, *Hyunsuk Suh, *Ilona Goukassian, *Eladio Rodriguez-Diaz, *Ousama A'amar, *Irving Bigio, *Stephanie Lee
Boston University, Boston, MA
Objective: Thyroid cancer is the most common endocrine malignancy. The current gold standard, 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. We assessed the potential to incorporate ESS into a 23 gauge needle biopsy to use in preoperative transcutaneous biopsy of the thyroid to differentiate benign from malignant thyroid nodules.
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