Use of an In Vivo Optical Probe to Discriminate Benign From Malignant Thyroid Nodules
Condition: Cancer; Thyroid
MeSH terms: Thyroid Diseases
Study type: Observational

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.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
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.
      
Keywords: Diagnosis; Fine Needle Aspiration Biopsy