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

This study will investigate the usefulness of an optical probe in the differentiation of thyroid cancer from normal thyroid tissue in a thyroidectomy specimen.

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Key information

Conditions

Thyroid Nodule Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Cancer Thyroid Diseases Thyroid Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Assess optical probe for the differentiation of thyroid cancer from normal thyroid tissue and benign thyroid nodules

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study title

The Role of an Optical Probe in the Detection of Thyroid Cancer and Normal Thyroid Tissue in a Thyroidectomy Specimen: A Pilot Study

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2015
First posted: Feb 15, 2013
Registry last updated: Mar 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed