Use of an In Vivo Optical Probe to Discriminate Benign From Malignant Thyroid Nodules
|ClinicalTrials.gov Identifier: NCT01401855|
Recruitment Status : Completed
First Posted : July 25, 2011
Last Update Posted : June 17, 2016
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|Official Title:||Optical Probe In Thyroid Cancer|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
|In Vivo Probe Prediction|
- Assess optical probe for the differentiation of thyroid cancer from normal thyroid tissue and benign thyroid nodules [ Time Frame: 2 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. 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401855
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Jennifer Rosen, MD/FACS||Boston University|