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Use of an In Vivo Optical Probe to Discriminate Benign From Malignant Thyroid Nodules

NCT01401855 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2016-06-17

No results posted yet for this study

Summary

This study will investigate the usefulness of an optical probe in the differentiation of thyroid cancer from normal thyroid tissue in a thyroidectomy specimen. This is the next step in the research that this team has conducted through our prior Institutional Review Board (IRB)H-28135, in which the investigators successfully demonstrated that use of the optical probe readings on thyroid specimens ex vivo could successfully discriminate benign from malignant disease. The Elastic Scattering Spectroscopy (ESS) probe has also been IRB approved and a clinical trial conducted in vivo at Boston University/Boston Medical Center by Dr. Satish Singh and Dr. Irving Bigio. The investigators intend to now bring this project to the clinical setting of thyroid disease. The optical real-time readings will be compared to the histological analysis from the same area. Subjects already undergoing thyroid biopsy for thyroid disease including thyroid nodules, thyroid cancer and thyroid goiter with nodules will be eligible to participate. During the already scheduled thyroid procedure using a fine needle aspiration biopsy needle, optical readings will be taken from the thyroid gland and these same areas will then be analyzed in the usual standard fashion. The reading will then be correlated with the histological results. In addition, if lymph nodes are biopsied as part of the evaluation they will also be tested prior to histological standard processing. All specimens and data will be de-identified once data collection and analysis is complete. Our goal is to use optical real-time readings to improve the differential diagnosis of benign from malignant thyroid nodules and avoid surgery for the purpose of diagnosis alone.

Conditions

Sponsors & Collaborators

  • Fraunhofer USA

    collaborator UNKNOWN

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Jennifer Rosen, MD/FACS · Boston University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01401855 on ClinicalTrials.gov