Use of an In Vivo Optical Probe to Discriminate Benign From Malignant Thyroid Nodules
Conditions
Cancer - Thyroid
Conditions: official terms
Thyroid Diseases
Conditions: Keywords
Diagnosis, Fine Needle Aspiration Biopsy
Study Type
Observational
Study Phase
Phase 1
Study Design
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Overall Status
Recruiting
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.
Detailed 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.

Results: All patients tolerated the procedure well and the additional time required for the ESS measurements was usually less than 30 seconds.under one minute. Initial analysis demonstrates that cellularity from the biopsy specimen was adequate for diagnosis, and spectra could be collected on all patients. Spectral appearance clearly differed between solid and liquid components portions of the thyroid nodule. Spectral analysis demonstrates a sensitivity to hemoglobin density. and ambient light, and a A signature of difference in waveforms could discriminate benign from malignant disease.

Conclusion: It is feasible to collect cytological material and ESS data real-time during an ultrasound-guided FNAB using a miniaturized combined ESS-biopsy needle probe in the usual clinical setting. The cytological specimen is adequate compared to conventional FNA biopsy, and the ESS data from this miniaturized optical probe is is of comparable quality to the standard ESS probe used in the diagnosis of other malignancies. Preliminary analysis reveals that there is a unique waveform signature that can differentiate benign from malignant thyroid nodules, using cytology or (or post-surgically histopathology) as the gold standard. With the collection of further data, an algorithm using ESS collected using our novel miniaturized ESS biopsy probe could potentially be used as an in-situ real time intra-operative diagnostic tool or as a minimally invasive adjunct to conventional FNA cytology with ultrasound or CT guidance.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Boston Medical Center
Boston, Massachusetts, United States
Status: Recruiting
Contact: Jennifer Rosen, MD, FACS - 617-414-8017 - jennifer.rosen@bmc.org
Start Date
June 2011
Completion Date
June 2014
Sponsors
Boston Medical Center
Source
Boston Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page