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Application of Deep-learning and Ultrasound Elastography in Opportunistic Screening of Breast Cancer

A Multi-center Study of Deep Learning Diagnosis and Ultrasound Elastography in Opportunistic Screening of Breast Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03851497
Enrollment
1200
Registered
2019-02-22
Start date
2019-01-01
Completion date
2021-01-01
Last updated
2021-03-26

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

Conditions

Breast Cancer

Brief summary

As the most common cancer expected to occur all over the world, breast cancer still faces with the unsatisfied diagnostic accuracy in US imaging. S-detect is a sophisticated CAD system for breast US imaging based on deep learning algorithms. E-breast is a software installed in US machines which automatically reveals tumor elastographic features. This multi-center study intends to further validate the diagnostic efficiency of S-detect and E-breast in opportunistic breast cancer screening populations in China. Our hypothesis is that S-detect and E-breast can increase the diagnostic accuracy and specificity as compared to routinely US examinations by doctors.

Interventions

None listed

Sponsors

Peking University Third Hospital
CollaboratorOTHER
Beijing Hospital
CollaboratorOTHER_GOV
Beijing Chao Yang Hospital
CollaboratorOTHER
Beijing Zhongguancun Hospital
CollaboratorUNKNOWN
Peking University Aerospace Center Hospital
CollaboratorOTHER
Beijing Anzhen Community Health Service Center
CollaboratorUNKNOWN
First Hospital of Tsinghua University
CollaboratorOTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
CollaboratorOTHER
The First Affiliated Hospital of Zhengzhou University
CollaboratorOTHER
Henan Provincial People's Hospital
CollaboratorOTHER
Third Affiliated Hospital of Zhengzhou University
CollaboratorOTHER
Xinxiang Central Hospital
CollaboratorOTHER
Henan Cancer Hospital
CollaboratorOTHER_GOV
First Hospital of China Medical University
CollaboratorOTHER
Shengjing Hospital
CollaboratorOTHER
Liaoning Cancer Hospital & Institute
CollaboratorOTHER
West China Hospital
CollaboratorOTHER
Sichuan Provincial People's Hospital
CollaboratorOTHER
Yan'an Hospital of Kunming City
CollaboratorUNKNOWN
Xi'an Central Hospital
CollaboratorOTHER
Ningxia Medical University
CollaboratorOTHER
First Hospital of Shijiazhuang City
CollaboratorOTHER
Chengde Central Hospital
CollaboratorOTHER_GOV
Qinghai Province Cancer Hospital
CollaboratorUNKNOWN
Gansu Cancer Hospital
CollaboratorOTHER
Shanghai Zhongshan Hospital
CollaboratorOTHER
Ruijin Hospital
CollaboratorOTHER
The Affiliated Hospital of Qingdao University
CollaboratorOTHER
Qingdao Central Hospital
CollaboratorOTHER
Jining First People's Hospital
CollaboratorOTHER
Linyi Tumour Hospital
CollaboratorOTHER
The First Affiliated Hospital of Shanxi Medical University
CollaboratorOTHER
The Second Affiliated Hospital of Harbin Medical University
CollaboratorOTHER
Second Hospital of Jilin University
CollaboratorOTHER
The Second Hospital of the West Coast New Area of Qingdao
CollaboratorUNKNOWN
Fudan University
CollaboratorOTHER
Tongji Hospital
CollaboratorOTHER
Jiangsu Province People's Hospital
CollaboratorUNKNOWN
Peking University Shougang Hospital
CollaboratorOTHER
Gansu Jiugang Hospital
CollaboratorUNKNOWN
Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Female over 18 years of age; * Had breast lesions detected by ultrasound. * No clinical symptoms such as nipple discharge, while breast lesions were not palpable. * Received breast surgery within one week of ultrasound examination. * Agreed to participant in this study and signed informed consent.

Exclusion criteria

* Patients who had received a biopsy of breast lesion before the ultrasound examination. * Patients who were pregnant or lactating. * Patients who were undergoing neoadjuvant treatment.

Design outcomes

Primary

MeasureTime frameDescription
Benign or malignant lesions as determined by pathologyFrom 2019.1.1 to 2020.1.1The pathological diagnosis of benign or malignant lesions from surgery samples

Countries

China

Outcome results

None listed

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