The Role of an Optical Probe in Thyroid Cancer Diagnosis: Pilot Study

Completed

• Conditions: Thyroid Nodule; Thyroid Neoplasms; Thyroid Cancer

• Registration Number: NCT01792492
• Lead Sponsor: Boston Medical Center

Brief 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.

Detailed Description

The optical real-time readings will be compared to the histological analysis from the same area. Subjects undergoing thyroid surgery for thyroid disease including thyroid nodules, thyroid cancer and thyroid goiter with nodules will be eligible to participate. After the removal of the thyroid gland, optical readings will be taken from the ex vivo 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 removed as part of the surgery they will also be tested prior to histological standard processing. All specimens and data will be de-identified.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2010-03
• Study First Submitted: 2011-07-08
• Study First Submitted QC: 2013-02-13
• Study First Posted: 2013-02-15
• Study Completion: 2015-11
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Subjects undergoing thyroid surgery for thyroid nodules, thyroid cancer, and thyroid goiter with nodules.

Exclusion Criteria

• Subjects whose thyroid specimens have been put in formalin

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess optical probe for the differentiation of thyroid cancer from normal thyroid tissue and benign thyroid nodules	two years	The objective is to assess a device called an optical probe for the differentiation of thyroid cancer from normal thyroid tissue, benign thyroid nodules or parathyroid glands, and the detection of thyroid cancer within lymph nodes using a hand-held spectroscope, compare the spectra from benign and malignant thyroid nodules and use this to discriminate benign from malignant nodules based on final histopathology or cytology as the gold standard.

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States