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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.
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 thyroid surgery. Using final surgical pathology as our gold standard, spectral analyses were compared with ex vivo measurements using a standard ESS probe.
Results: Initial analysis showed no difference between the standard probe and our miniaturized version in pulse number, sensitivity to hemoglobin density and ambient light.
Conclusion: A miniaturized ESS biopsy probe can be built and has comparable utility to the standard ESS probe used in the diagnosis of other malignancies. 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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Abstract Submission Deadline:
May 5, 2014

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August 13, 2014

Early Bird Registration Deadline:
August 11, 2014
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