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

NCT01401855 | Completed

• 1 other identifier: H-29527
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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. 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

Cancer; Thyroid

Keywords

Diagnosis; Fine Needle Aspiration Biopsy

Outcome Measures

Primary Outcomes (1)

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

  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. The gold standard for diagnosis is ultrasound guided fine needle aspiration biopsy of the nodule. Based on cytology from Fine Needle Aspiration (FNA), 10% of nodules are cancer, 70% are benign (not cancer) and 20% are "indeterminate." The proposed device aims to decrease the number of patients that undergo surgery for diagnosis.

  2 years

Study Arms (2)

In Vivo Probe Prediction

Cytology Results

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects, male and female, undergoing thyroid fine needle aspiration biopsy at Boston Medical Center ages 18 and older. Study population includes all ethnic groups.

You may qualify if:

• Subjects undergoing thyroid biopsy for thyroid nodules, thyroid cancer, and thyroid goiter with nodules. Only those patients requiring sampling under established standard of care criteria and already scheduled to undergo biopsy for clinical purposes will undergo optical biopsy at the same time as their physical biopsy.

You may not qualify if:

• Subjects with nodules smaller than 1 cm, infectious diseases, on medication (such as coumadin) that may interfere with optical readings

Sponsors & Collaborators

• Boston Medical Center: lead
• Fraunhofer USA: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Neoplasms; Thyroid Diseases; Disease

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Rosen, MD/FACS

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 22, 2011
• First Posted: July 25, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 17, 2016

Record last verified: 2016-06

Locations

US (1)