Breast Cancer Clinical Trial
Official title:
A Multi-center Study of Differential Diagnosis Breast Nodules by Ultrasound Artificial Intelligence and Ultrasound Elastography
The application of computer-aided diagnosis (CAD) technology "S-Detect" enables qualitative and quantitative automated analysis of ultrasound images to obtain objective, repeatable and more accurate diagnostic results. The Elastic Contrast Index (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-Detect technology for benign and malignant breast nodules and evaluate the differential diagnosis consistency of the ultrasound S-Detect technique and the examiner for benign and malignant breast nodules and explore the differential diagnosis value of Samsung ultrasound elastic contrast Index (ECI) technique for benign and malignant breast nodules.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | February 18, 2020 |
Est. primary completion date | January 18, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Had breast 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 breast 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, First People's Hospital of Jiangxia District, Wuhan City, Huai'an First People's Hospital, Huainan People's Hospital, Huangshi Central 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 JH, Kang BJ, Baek JE, Lee HS, Kim SH. Application of computer-aided diagnosis in breast ultrasound interpretation: improvements in diagnostic performance according to reader experience. Ultrasonography. 2018 Jul;37(3):217-225. doi: 10.14366/usg.17046 — View Citation
Di Segni M, de Soccio V, Cantisani V, Bonito G, Rubini A, Di Segni G, Lamorte S, Magri V, De Vito C, Migliara G, Bartolotta TV, Metere A, Giacomelli L, de Felice C, D'Ambrosio F. Automated classification of focal breast lesions according to S-detect: vali — View Citation
Kim K, Song MK, Kim EK, Yoon JH. Clinical application of S-Detect to breast masses on ultrasonography: a study evaluating the diagnostic performance and agreement with a dedicated breast radiologist. Ultrasonography. 2017 Jan;36(1):3-9. doi: 10.14366/usg. — View Citation
Kowal M, Filipczuk P, Obuchowicz A, Korbicz J, Monczak R. Computer-aided diagnosis of breast cancer based on fine needle biopsy microscopic images. Comput Biol Med. 2013 Oct;43(10):1563-72. doi: 10.1016/j.compbiomed.2013.08.003. Epub 2013 Aug 19. — 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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