Thyroid Nodule Clinical Trial
Official title:
A Multi-center Study of Differential Diagnosis Thyroid Nodules by Ultrasound Artificial Intelligence and Ultrasound Elastography
NCT number | NCT03887611 |
Other study ID # | 2019(S074) |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 18, 2019 |
Est. completion date | March 18, 2020 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Xin-Wu Cui | Wuhan | Hubei |
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 |
China,
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
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 |
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