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Application of Ultrasound Artificial Intelligence and Elastography in Differential Diagnosis of Thyroid Nodules

A Multi-center Study of Differential Diagnosis Thyroid Nodules by Ultrasound Artificial Intelligence and Ultrasound Elastography

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03887611
Enrollment
2000
Registered
2019-03-25
Start date
2019-01-18
Completion date
2020-03-18
Last updated
2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Nodule

Keywords

Artificial Intelligence; Ultrasound;Thyroid nodule; ECI

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 64,300 new cases of thyroid cancer occurred in the world in 2016, and about 1,980 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 assessment.This 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.

Interventions

Ultrasound diagnosis of lesions with Samsung S-Detect and ECI technology

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Wuhan Hospital of Traditional Chinese Medicine
CollaboratorOTHER
Macheng People's Hospital
CollaboratorUNKNOWN
Huangshi Central Hospital
CollaboratorOTHER
Affiliated Hospital of Jiangsu University
CollaboratorOTHER
The First People's Hospital of Yichang
CollaboratorUNKNOWN
Yichang Second People's Hospital
CollaboratorOTHER
Xiangyang Central Hospital
CollaboratorOTHER
The Second Hospital of Anhui Medical University
CollaboratorOTHER
Anqing People's Hospital
CollaboratorUNKNOWN
Huainan People's Hospital
CollaboratorUNKNOWN
Taizhou Hospital
CollaboratorOTHER
Wenzhou Central Hospital
CollaboratorOTHER
Xuzhou First People's Hospital
CollaboratorUNKNOWN
The Central Hospital of Lishui City
CollaboratorOTHER
Huai'an First People's Hospital
CollaboratorOTHER
WISCO General Hospital
CollaboratorUNKNOWN
Jiangxia District First People's Hospital
CollaboratorUNKNOWN
Enshi State Central Hospital
CollaboratorUNKNOWN
Lianyungang Third People's Hospital
CollaboratorUNKNOWN
First People's Hospital of Xianyang
CollaboratorOTHER
Xin-Wu Cui
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Had thyroid lesions detected by ultrasound 2. Age 18 or older 3. Upcoming FNAB or surgery 4. Signing informed consent

Exclusion criteria

1. Patients who had received a biopsy of thyroid lesion before the ultrasound examination 2. Can not cooperate with the test operation 3. Patients who were pregnant or lactating 4. Patients who were undergoing neoadjuvant treatment.

Design outcomes

Primary

MeasureTime frameDescription
Benign or malignant lesions as determined by pathologyBefore surgery or biopsyThe pathological diagnosis of benign or malignant lesions from surgery samples
Elastic ratioBefore surgery or biopsyClear ECI value

Countries

China

Contacts

Primary ContactLi-Qiang Zhou, MD
zlq_1118@hust.edu.cn15387076275

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026