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

Cancer Clinical Trial

Official title:

Optical Probe In Thyroid Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401855
• Other study ID #: H-29527
• Status: Completed
• Phase: Phase 1
• First received: July 22, 2011
• Last updated: June 15, 2016
• Start date: June 2011
• Est. completion date: June 2014

Study information

• Verified date: June 2016
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Background: Thyroid cancer is the most common endocrine malignancy. The current gold standard, fine-needle aspiration (FNA) biopsy, yields approximately 10-25% of indeterminate results, leading to patients undergoing thyroidectomy for diagnosis. Elastic scattering spectroscopy (ESS) is a new, minimally invasive optical-biopsy technique, mediated by fiber-optic probes, that which is sensitive to cellular and sub-cellular morphological features. We assessed the potential to incorporate an ESS probe into a 23-gauge needle biopsy to use in preoperative trans-cutaneous biopsy of the thyroid to differentiate benign from malignant thyroid nodules.

Methods: We designed and built a miniaturized ESS probe that can fit through a 23-gauge biopsy needle and tested it under an IRB-approved protocol on 34 patients undergoing ultrasound-guided FNA biopsy of thyroid nodules in the endocrine clinic. ESS data was collected during the conduct of their biopsy using optical 5 repetitive readings from three distinct locations within the thyroid nodule. Using cytology as our gold standard, spectral analyses were compared between benign and malignant thyroid nodules. For indeterminate cytology, final post-surgery pathology of the tissue was used for the comparison.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cancer
• Thyroid
• Thyroid Diseases

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Fraunhofer USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes