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The Role of an Optical Probe in the Detection of Thyroid Cancer and Normal Thyroid Tissue in a Thyroidectomy Specimen: A Pilot Study


N/A
N/A
N/A
Open (Enrolling)
Both
Thyroid Nodule, Thyroid Neoplasms, Thyroid Cancer

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Trial Information

The Role of an Optical Probe in the Detection of Thyroid Cancer and Normal Thyroid Tissue in a Thyroidectomy Specimen: A Pilot Study


The optical real-time readings will be compared to the histological analysis from the same
area. Subjects undergoing thyroid surgery for thyroid disease including thyroid nodules,
thyroid cancer and thyroid goiter with nodules will be eligible to participate. After the
removal of the thyroid gland, optical readings will be taken from the ex vivo 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 removed as
part of the surgery they will also be tested prior to histological standard processing. All
specimens and data will be de-identified.


Inclusion Criteria:



- Subjects undergoing thyroid surgery for thyroid nodules, thyroid cancer, and thyroid
goiter with nodules.

Exclusion Criteria:

- Subjects whose thyroid specimens have been put in formalin

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Assess optical probe for the differentiation of thyroid cancer from normal thyroid tissue and benign thyroid nodules

Outcome Description:

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 using a hand-held spectroscope, compare the spectra from benign and malignant thyroid nodules and use this to discriminate benign from malignant nodules based on final histopathology or cytology as the gold standard.

Outcome Time Frame:

two years

Safety Issue:

No

Principal Investigator

Jennifer E Rosen, M.D. FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston Medical Center

Authority:

United States: Institutional Review Board

Study ID:

H28135

NCT ID:

NCT01792492

Start Date:

June 2009

Completion Date:

November 2013

Related Keywords:

  • Thyroid Nodule
  • Thyroid Neoplasms
  • Thyroid Cancer
  • Thyroid Neoplasms
  • Optical Devices
  • Spectrum Analysis
  • Thyroid diseases
  • Neoplasms
  • Thyroid Neoplasms
  • Thyroid Diseases
  • Thyroid Nodule

Name

Location

Boston Medical CenterBoston, Massachusetts  02118