Viewing Study NCT03887611



Ignite Creation Date: 2024-05-06 @ 12:54 PM
Last Modification Date: 2024-10-26 @ 1:06 PM
Study NCT ID: NCT03887611
Status: UNKNOWN
Last Update Posted: 2019-03-26
First Post: 2019-03-21

Brief Title: Application of Ultrasound Artificial Intelligence and Elastography in Differential Diagnosis of Thyroid Nodules
Sponsor: Xin-Wu Cui
Organization: Tongji Hospital

Study Overview

Official Title: A Multi-center Study of Differential Diagnosis Thyroid Nodules by Ultrasound Artificial Intelligence and Ultrasound Elastography
Status: UNKNOWN
Status Verified Date: 2019-03
Last Known Status: RECRUITING
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 application of computer-aided diagnosis CAD technology S-DetectTM enables qualitative and quantitative automated analysis of ultrasound images to obtain objective repeatable and more accurate diagnostic results The Elastic Contrast Factor ECI technique unlike conventional strain-elastic imaging techniques can evaluate the elastic distribution in the region of interest The purpose of the study was to evaluate the differential diagnosis value of ultrasound S-DetectTM technology for benign and malignant thyroid nodules and evaluate the consistency of ultrasound S-DetectTM technology and sonographer in the differential diagnosis of thyroid nodules and explore the differential diagnosis value of Samsung ultrasound ECI technology for benign and malignant thyroid nodules
Detailed Description: Thyroid nodules are one of the most common nodular lesions in adults and their incidence is increasing Clinical studies have found that about 10-15 of adults have thyroid nodules most of which are benign nodules only 7 of thyroid nodules tend to be malignant but if not treated promptly 5 of patients will still from benign to malignant The incidence of thyroid cancer increases with age According to the National Cancer Research Center about 64300 new cases of thyroid cancer occurred in the world in 2016 and about 1980 died of thyroid cancer Timely and accurate detection of thyroid nodules and differentiation of benign and malignant are important for improving clinical treatment and improving patient prognosis

S-Detect technology is a computer-aided CAD system recently developed by Samsung Medical Center for thyroid ultrasound to assist in morphological analysis based on the Thyroid Imaging Reporting and Data System TI-RADS description and final assessmentThis provides a new way to identify the benign and malignant thyroid nodules

The ECI technique unlike conventional strain-elastic imaging technology performs an elastic analysis of the entire two-dimensional image Moreover when measuring the elastic ratio it is only necessary to place a region of interest ROI at the nodule Compared with the average elasticity of the surrounding area it is more reflective of the elastic ratio of the mass to the surrounding tissue

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None