Diagnostic Performance of Ultrasound Elastography for Detection of Thyroid Cancer (Elastography)

October 30, 2016 updated by: Dong Jun Lim

Validation of Diagnostic Performance of Ultrasound Elastography for Detection of Thyroid Cancer

For patients with thyroid gland nodule, fine-needle aspiration biopsy has been proved to be an efficient tool for thyroid cancer diagnosis. However, it is somewhat an invasive procedure and is subject to sampling and analysis uncertainties. Thus, improved, more reliable criteria for determining which nodule should be be aspirated are needed. Ultrasound elastography has been shown to be useful in the differential diagnosis of breast and prostate cancers. Ultrasound elastography also may discriminate malignant from benign nodule.

Study Overview

Status

Unknown

Conditions

Detailed Description

To prospectively evaluate the elastographic appearance of thyroid cancer and explore the potential sensitivity and specificity of elastography for differentiating benign and malignant tumors, with histopathologic analysis as the reference standard.

Study Type

Observational

Enrollment (Anticipated)

590

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Seocho-gu, Seoul, Korea, Republic of, 137-701
        • Recruiting
        • Seoul St Mary's Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Min Hee Kim, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The patients with thyroid nodule who visit tertiary hospital for fine needle aspiration biopsy

Description

Inclusion Criteria:

- The patients with thyroid nodule who are supposed to take fine needle aspiration biopsy

Exclusion Criteria:

- The patients who do not want to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
FNAB of Thyroid nodule
The Patients with thyroid nodule who are scheduled for FNAB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of elastography using in-vivo compression for detection of thyroid cancer
Time Frame: 1 year
Measuring ECI(Elasticity contrast index) of thyroid nodule by ultrasound elastography
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of the parameters which could have influence on the diagnostic performance of ultrasound elastography using in-vivo compression
Time Frame: One year
Analysis of clinical characteristics of thyroid nodules and patients which are related to the diagnostic performance of ultrasound elastography
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong Jun Lim

Investigators

  • Principal Investigator: Dong Jun Lim, Dr., Associate Professor, Head, Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, The Catholic University of Korea
  • Study Director: Min Hee Kim, Dr., Clinical Assistant Professor, Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, The Catholic University of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (Estimate)

June 4, 2015

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 30, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SeoulStMary

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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