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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Boston Medical Center
Sponsor:
Collaborator:
Fraunhofer USA
Information provided by (Responsible Party):
Jennifer Rosen, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01401855
First received: July 22, 2011
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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.


Condition Phase
Cancer
Thyroid
Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Optical Probe In Thyroid Cancer

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Assess optical probe for the differentiation of thyroid cancer from normal thyroid tissue and benign thyroid nodules [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 300
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
In Vivo Probe Prediction
Cytology Results

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401855

Contacts
Contact: Jennifer Rosen, MD,FCAS 617-414-8017 jennifer.rosen@bmc.org

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Jennifer Rosen, MD, FACS    617-414-8017    jennifer.rosen@bmc.org   
Principal Investigator: Jennifer Rosen, MD, FACS         
Sponsors and Collaborators
Boston Medical Center
Fraunhofer USA
Investigators
Principal Investigator: Jennifer Rosen, MD/FACS Boston University
  More Information

No publications provided

Responsible Party: Jennifer Rosen, Assistant Professor of Medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01401855     History of Changes
Other Study ID Numbers: H-29527
Study First Received: July 22, 2011
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
Diagnosis
Fine Needle Aspiration Biopsy

Additional relevant MeSH terms:
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 27, 2014