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

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ClinicalTrials.gov Identifier: NCT02937467
Expanded Access Status : Available
First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Collaborator:
Shanghai 10th People's Hospital
Information provided by (Responsible Party):
Kun Yan, Beijing Cancer Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment
Thyroid Nodules Device: SWE

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.

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Study Type : Expanded Access
Official Title: Evaluation of Shear Wave Elastography in the Diagnosis and Management of Thyroid Nodules in Chinese Population: A Prospective, Multicenter Study
Study Start Date : December 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases


Intervention Details:
  • Device: SWE
    a novel ultrasound-based elastographic method, a new real-time, quantitative, operator-independent, and reproducible technique

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02937467


Contacts
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Contact: liu wenying, Doctor 86-10-88196941 liuwy23@sina.com
Contact: liu boji, Doctor 86-13641668014 jxjj1990@126.com

Sponsors and Collaborators
Beijing Cancer Hospital
Shanghai 10th People's Hospital
Investigators
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Principal Investigator: yan kun, Doctor Beijing Cancer Hospital
Principal Investigator: xu huixiong, Doctor Shanghai 10th People's Hospital
Publications of Results:
Other Publications:
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Responsible Party: Kun Yan, chief director, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT02937467    
Other Study ID Numbers: SHSY-IEC-3.0/15-78/01
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Keywords provided by Kun Yan, Beijing Cancer Hospital:
SWE
diagnosis
Additional relevant MeSH terms:
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Thyroid Nodule
Thyroid Diseases
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms