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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01792492

Enrollment

Registered

2013-02-15

Start date

2009-06-30

Completion date

2015-11-30

Last updated

2016-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Cancer, Thyroid Neoplasms, Thyroid Nodule

Keywords

Thyroid Neoplasms, Optical Devices, Spectrum Analysis, Thyroid diseases

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results