Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Role of an Optical Probe in Thyroid Cancer Diagnosis: Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01792492
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
Stephanie Lee, Boston Medical Center

Brief 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.

Condition or disease
Thyroid Nodule Thyroid Neoplasms Thyroid Cancer

Detailed Description:
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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of an Optical Probe in the Detection of Thyroid Cancer and Normal Thyroid Tissue in a Thyroidectomy Specimen: A Pilot Study
Study Start Date : June 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid




Primary Outcome Measures :
  1. Assess optical probe for the differentiation of thyroid cancer from normal thyroid tissue and benign thyroid nodules [ Time Frame: two 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 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tertiary hospital setting Urban hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792492


Locations
Layout table for location information
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Jennifer E Rosen, M.D. FACS Boston Medical Center

Layout table for additonal information
Responsible Party: Stephanie Lee, Assistant Professor of Medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01792492     History of Changes
Other Study ID Numbers: H28135
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Stephanie Lee, Boston Medical Center:
Thyroid Neoplasms
Optical Devices
Spectrum Analysis
Thyroid diseases
Additional relevant MeSH terms:
Layout table for MeSH terms
Thyroid Neoplasms
Thyroid Nodule
Thyroid Diseases
Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms