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Construction and validity testing of an ultrasound artificial intelligence diagnosis platform for breast diseases

Construction and validity testing of an ultrasound artificial intelligence diagnosis platform for breast diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043655
Enrollment
Unknown
Registered
2021-02-24
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-22

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

Conditions

Breast cancer

Interventions

Gold Standard:Pathological diagnosis
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ultrasound&#32
imaging&#32
histological&#32
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Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Patients with breast masses on examinations such as ultrasound, mammography, or MRI of any kind, especially BI-RADS category 3 and 4 patients; (2) Informed of this study and signed an informed consent form. Voluntary shear wave elastography examination; (3) Agreed and combined with puncture biopsy, rotary biopsy, or surgical treatment, and finally obtained the pathological diagnosis.

Exclusion criteria

Exclusion criteria: (1) Pregnancy or lactation; (2) Implants in the breast; (3) History of surgery on the affected side; (4) History of malignant tumor and other cachexia.

Design outcomes

Primary

MeasureTime frame
Radiomic features;assess the breast cancer risk via deep-learning based AI system;Mammogram breast density types;BI-RADS classification (mammogram);Biopsy Method;Histological type;WHO histological grading;Vessel carcinoma embolus;Nerve Violation;ER;PR;HER2;FISH;KI-67;Molecular subtypes (biopsy);Lymph node biopsy results;cTNM staging;Neoadjuvant treatment programs;Surgery Date;Surgical method;Histological type (surgery);Number of positive SLN by intraoperative cryopreservation;Number of positive SLN by postoperative paraffin examination;Number of NSLN positives;pTNM staging;Molecular subtypes (surgery);Concordance of biopsy and postoperative molecular subtypes;Miller-Payne Classification;RCB Classification;Whether or not pCR;Adjunctive therapy programs;Prognosis Information;Pathogenomic features;Mass size;Echo;Boundary of the mass;Mass pattern;Calcification;BI-RADS Classification;PSV;EDV;RI;S/D;Emax;Emin;Emean;SD;Eratio;Area;Berg' color scoring;Tozaki M four-color model;

Secondary

MeasureTime frame
age;Menstrual status;Personal Cancer History;Family history of cancer;Location;Distance to nipple;

Countries

China

Contacts

Public ContactJing Pei

The First Affiliated Hospital of Anhui Medical University

peijing@ahmu.edu.cn+86 13966668272

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026