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

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.

Study Overview

• Status: Unknown
• Conditions: Thyroid Nodule
• Intervention / Treatment: Device: Ultrasound diagnosis

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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Li-Qiang Zhou, MD; Phone Number: 15387076275; Email: zlq_1118@hust.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Xin-Wu Cui
      • Contact: Xin-Wu Cui, PhD,MD; Phone Number: 15927103161; Email: cuixinwu@live.cn
      • Contact: You-Bin Deng, PhD,MD; Phone Number: 13871197838; Email: ybdeng2007@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with thyroid nodules in large tertiary hospitals

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

thyroid nodules; Those with one or more breast nodules, age 18 or older, upcoming FNAB or surgery and signed informed consent.Those without adverse effects on the test or threatening other candidates, such as mental illness, pregnancy, poor ultrasound image quality, history of thyroid surgery or thyroid biopsy, simple cystic nodules, calcification, excessive mass or too small, the S-DetectTM system can not identify the boundary of the tumor, the basic information is incomplete.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Benign or malignant lesions as determined by pathology	The pathological diagnosis of benign or malignant lesions from surgery samples	Before surgery or biopsy
Elastic ratio	Clear ECI value	Before surgery or biopsy

Collaborators and Investigators

• Sponsor: Xin-Wu Cui
• Collaborators: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; The Central Hospital of Lishui City; Wenzhou Central Hospital; Affiliated Hospital of Jiangsu University; Taizhou Hospital; The Second Hospital of Anhui Medical University; Huai'an First People's Hospital; Xiangyang Central Hospital; Wuhan Hospital of Traditional Chinese Medicine; Huangshi Central Hospital, China; Macheng People's Hospital; The First People's Hospital of Yichang; The Second People's Hospital of Yichang; Anqing People's Hospital; Huainan People's Hospital; Xuzhou First People's Hospital; WISCO General Hospital; Enshi State Central Hospital; Lianyungang Third People's Hospital; Xiangyang First People's Hospital; Jiangxia District First People's Hospital
• Investigators: Study Chair: Xin-Wu Cui, PhD,MD, Tongji Hospital; Study Chair: You-Bin Deng, PhD,MD, Tongji Hospital

Publications and helpful links

General Publications

• 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):546-552. doi: 10.1089/thy.2016.0372. Epub 2017 Feb 28.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2019
• Primary Completion (Anticipated): January 18, 2020
• Study Completion (Anticipated): March 18, 2020

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 23, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Ultrasound;Thyroid nodule; ECI
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: 2019(S074)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Not public because of the personal information of the participants

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No