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
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|
SWE can prove the diagnostic performance in the differentiation of benign and malignant thyroid lesions
- to assess the performance of SWE for identification of benign and malignant thyroid nodules in multicenter study;
- calculate the optimal cutoff value for each parameter in multicenter study
- Secondary purpose to evaluate the application value of SWE for uncertain nodules by FNA.
|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|
- Device: SWE
a novel ultrasound-based elastographic method, a new real-time, quantitative, operator-independent, and reproducible technique
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
|Contact: liu wenying, Doctorfirstname.lastname@example.org|
|Contact: liu boji, Doctoremail@example.com|
|Principal Investigator:||yan kun, Doctor||Beijing Cancer Hospital|
|Principal Investigator:||xu huixiong, Doctor||Shanghai 10th People's Hospital|