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

Thyroid Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03887611
• Other study ID #: 2019(S074)
• Status: Recruiting
• Start date: January 18, 2019
• Est. completion date: March 18, 2020

Study information

• Verified date: March 2019
• Source: Tongji Hospital
• Contact: Li-Qiang Zhou, MD
• Phone: 15387076275
• Email: zlq_1118[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 18, 2020
• Est. primary completion date: January 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Intervention

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

Locations

Country	Name	City	State
China	Xin-Wu Cui	Wuhan	Hubei

Sponsors (22)

Lead Sponsor

Collaborator

Xin-Wu Cui

Affiliated Hospital of Jiangsu University, Anqing People's Hospital, Enshi State Central Hospital, Huai'an First People's Hospital, Huainan People's Hospital, Huangshi Central Hospital, Jiangxia District First People's Hospital, Lianyungang Third People's Hospital, Macheng People's Hospital, Taizhou Hospital, The Central Hospital of Lishui City, The First People's Hospital of Yichang, the Second Affiliated Hospital of Anhui Medical University, The Second People's Hospital of Yichang, Wenzhou Central Hospital, WISCO General Hospital, Wuhan Hospital of Traditional Chinese and Western Medicine, Xiangyang Central Hospital, Xiangyang First People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Xuzhou First People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Choi YJ, Baek JH, Park HS, Shim WH, Kim TY, Shong YK, Lee JH. A Computer-Aided Diagnosis System Using Artificial Intelligence for the Diagnosis and Characterization of Thyroid Nodules on Ultrasound: Initial Clinical Assessment. Thyroid. 2017 Apr;27(4):546 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Benign or malignant lesions as determined by pathology	The pathological diagnosis of benign or malignant lesions from surgery samples	Before surgery or biopsy
Primary	Elastic ratio	Clear ECI value	Before surgery or biopsy