The Multi-Center Study of Shear Wave Elastography on Thyroid Nodules

October 15, 2016 updated by: Kun Yan, Peking University Cancer Hospital & Institute

Evaluation of Shear Wave Elastography in the Diagnosis and Management of Thyroid Nodules in Chinese Population: A Prospective, Multicenter Study

The incidence rates of thyroid cancers have increased in the past decade. Additionally, up to 68% of people have thyroid nodules. Consequently, a precise evaluation of thyroid nodules is very important and can avoid unnecessary biopsy of benign nodules. Shear wave elastography(SWE), a novel ultrasound-based elastographic method, is a new real-time, quantitative, operator-independent, and reproducible technique. Briefly, shear wave elastography uses a radiation force produced by an ultrasonic beam to stress tissues and ultrafast sonographic tracking techniques to measure the speed of shear waves. Based on the Young modulus formula, tissue elasticity can be derived from the shear wave propagation speed, and a real-time color-coded elastogram can be displayed, showing softer tissue in blue and stiffer tissue in red.

There are lots of research confirmed that SWE has a certain value in the diagnosis of thyroid carcinoma. These studies include prospective studies and retrospective studies, but both belong to a single center study. It has not been applied to the study of the multicenter of thyroid disease.

The main purpose of the study is to assess the performance of SWE for identification of benign and malignant thyroid nodules and calculate the optimal cutoff value for each parameter in multicenter study; the secondary purpose is to evaluate the application value of SWE for uncertain nodules by FNA.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Detailed Description

SWE can prove the diagnostic performance in the differentiation of benign and malignant thyroid lesions

  1. Main purpose

    1. to assess the performance of SWE for identification of benign and malignant thyroid nodules in multicenter study;
    2. calculate the optimal cutoff value for each parameter in multicenter study
  2. Secondary purpose to evaluate the application value of SWE for uncertain nodules by FNA.

Study Type

Expanded Access

Contacts and Locations

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

Study Contact

  • Name: liu wenying, Doctor
  • Phone Number: 86-10-88196941
  • Email: liuwy23@sina.com

Study Contact Backup

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. the size of the lesion is between 0.5～4cm
  2. the solid components in the lesion>50%；
  3. all patients perform FNA or surgery in one month after SWE examination

Exclusion Criteria:

  1. patients who are unwilling or unable to provide informed consent
  2. Woman who is pregnant or breastfeeding;
  3. Thyroid nodules with calcified which is beyond 1/2 diameter of lesion
  4. patients who have history of surgery、FNA or thermal ablation in ipsilateral thyroid
  5. patients who have serious cardiopulmonary diseases

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?

Collaborators and Investigators

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

Sponsor

Peking University Cancer Hospital & Institute

Collaborators

Shanghai 10th People's Hospital

Investigators

  • Principal Investigator: yan kun, Doctor, Peking University Cancer Hospital & Institute
  • Principal Investigator: xu huixiong, Doctor, Shanghai 10th People's Hospital

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

December 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 15, 2016

First Submitted That Met QC Criteria

October 15, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 15, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHSY-IEC-3.0/15-78/01

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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