Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-04 @ 8:41 PM
Study NCT ID:
NCT02937467
Status:
AVAILABLE
Last Update Posted:
2016-10-18
First Post:
2016-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Multi-Center Study of Shear Wave Elastography on Thyroid Nodules
Sponsor:
Peking University Cancer Hospital & Institute
Organization:
Study Overview
Official Title:
Evaluation of Shear Wave Elastography in the Diagnosis and Management of Thyroid Nodules in Chinese Population: A Prospective, Multicenter Study
Status:
AVAILABLE
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: