Thyroid nodules are a frequent clinical finding and the most common endocrine malignancy is thyroid cancer. The standard of care in the management of a patient with a thyroid nodule is to perform a preoperative fine needle aspiration (FNA) biopsy of the suspect nodule under ultrasound imaging guidance. In a significant percentage of the cases, cytological assessment of the biopsy material yields indeterminate results, the consequence of which is diagnostic thyroidectomy. Unfortunately, 75–80% of diagnostic thyroidectomies following indeterminate cytology result in benign designation by post-surgery histopathology, indicating potentially unnecessary surgeries. Clearly, the potential exists for the improvement in patient care and the reduction of overall procedure costs if an improved preoperative diagnostic technique was developed. Elastic scattering spectroscopy (ESS) is an optical biopsy technique that is mediated by optical fiber probes and has been shown to be effective in differentiating benign from malignant thyroid tissue in ex vivo surgical tissue samples. The goal of the current research was to integrate the ESS fiber optic probes into a device that can also collect cells for cytological assessment and, thus, enable concurrent spectroscopic interrogation and biopsy of a suspect nodule with a single needle penetration. The primary challenges to designing the device included miniaturizing the standard ESS fiber optic probe to fit within an FNA needle and maintaining the needle’s aspiration functionality. We demonstrate the value of the fabricated prototype devices by assessing their preliminary performance in an on-going clinical study with >120 patients. The devices have proven to be clinically friendly, collecting both aspirated cells and optical data from the same location in thyroid nodules and with minimal disruption of clinical procedure. In the future, such integrated devices could be used to complement FNA-based cytological results and have the potential to both reduce the number of diagnostic thyroidectomies on benign nodules and improve the surgical approach for patients with thyroid malignancies, thereby, decreasing healthcare costs and improving patient outcomes.
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Boston University,
Boston University,
Section of Surgical Oncology
and Surgical Endocrinology,
School of Medicine,
Boston University,
Section of Endocrinology,
Diabetes, and Nutrition,
School of Medicine,
Boston University,
Boston University,
Boston, MA 02215
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June 2014
Research-Article
Integrated Device for in Vivo Fine Needle Aspiration Biopsy and Elastic Scattering Spectroscopy in Preoperative Thyroid Nodules
John C. Briggs,
John C. Briggs
Fraunhofer USA–CMI
,Brookline, MA 02446
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Ousama A’amar,
Boston University,
Ousama A’amar
Department of Biomedical Engineering
,Boston University,
Boston, MA 02215
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Irving Bigio,
Boston University,
Irving Bigio
Department of Biomedical Engineering
,Boston University,
Boston, MA 02215
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Jennifer E. Rosen,
Section of Surgical Oncology
and Surgical Endocrinology,
School of Medicine,
Boston University,
Jennifer E. Rosen
Department of Surgery
,Section of Surgical Oncology
and Surgical Endocrinology,
School of Medicine,
Boston University,
Boston, MA 02118
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Stephanie L. Lee,
Section of Endocrinology,
Diabetes, and Nutrition,
School of Medicine,
Boston University,
Stephanie L. Lee
Department of Medicine
,Section of Endocrinology,
Diabetes, and Nutrition,
School of Medicine,
Boston University,
Boston, MA 02118
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Andre Sharon,
Andre Sharon
Fraunhofer USA–CMI
,Brookline, MA 02446
;Department of Mechanical Engineering,
Boston University,
Boston, MA 02215
Boston University,
Boston, MA 02215
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Alexis F. Sauer-Budge
Boston University,
Boston, MA 02215
Alexis F. Sauer-Budge
Fraunhofer USA–CMI
,Brookline, MA 02446
;Department of Biomedical Engineering
,Boston University,
Boston, MA 02215
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John C. Briggs
Fraunhofer USA–CMI
,Brookline, MA 02446
Ousama A’amar
Department of Biomedical Engineering
,Boston University,
Boston, MA 02215
Irving Bigio
Department of Biomedical Engineering
,Boston University,
Boston, MA 02215
Jennifer E. Rosen
Department of Surgery
,Section of Surgical Oncology
and Surgical Endocrinology,
School of Medicine,
Boston University,
Boston, MA 02118
Stephanie L. Lee
Department of Medicine
,Section of Endocrinology,
Diabetes, and Nutrition,
School of Medicine,
Boston University,
Boston, MA 02118
Andre Sharon
Fraunhofer USA–CMI
,Brookline, MA 02446
;Department of Mechanical Engineering,
Boston University,
Boston, MA 02215
Boston University,
Boston, MA 02215
Alexis F. Sauer-Budge
Fraunhofer USA–CMI
,Brookline, MA 02446
;Department of Biomedical Engineering
,Boston University,
Boston, MA 02215
Manuscript received August 30, 2013; final manuscript received January 16, 2014; published online March 7, 2014. Assoc. Editor: Carl A. Nelson.
J. Med. Devices. Jun 2014, 8(2): 021003 (6 pages)
Published Online: March 7, 2014
Article history
Received:
August 30, 2013
Revision Received:
January 16, 2014
Citation
Briggs, J. C., A’amar, O., Bigio, I., Rosen, J. E., Lee, S. L., Sharon, A., and Sauer-Budge, A. F. (March 7, 2014). "Integrated Device for in Vivo Fine Needle Aspiration Biopsy and Elastic Scattering Spectroscopy in Preoperative Thyroid Nodules." ASME. J. Med. Devices. June 2014; 8(2): 021003. https://doi.org/10.1115/1.4026577
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