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Ultrasoundomics and Pathomics with Artifificial Intelligence for Preoperative Prediction of Axillary Lymph Node Metastasis in Early Breast Cancer: a Multi-Center Clinical Study

Ultrasoundomics and Pathomics with Artifificial Intelligence for Preoperative Prediction of Axillary Lymph Node Metastasis in Early Breast Cancer: a Multi-Center Clinical Study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900027497
Enrollment
Unknown
Registered
2019-11-16
Start date
2019-12-01
Completion date
Unknown
Last updated
2020-05-18

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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Sponsors

Sun Yat-Sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Ultrasound is classified as a single breast mass lesion of 4A to 5; 2) The maximum diameter of the lesion is less than 4cm, the width of the probe covers the entire lesion, and the normal tissue image is required on both sides of the lesion; 3) Perform a needle biopsy before surgery to determine malignancy (pathological image of the needle biopsy to be scanned); 4) After the patient underwent ultrasound examination, the sentinel lymph biopsy or axillary lymph node dissection was performed to determine the number of axillary lymph node metastasis.

Exclusion criteria

Exclusion criteria: 1) Excisional biopsy or Mammoto minimally invasive surgery on the target lesion before image acquisition. 2) New adjuvant chemotherapy for target lesions before image acquisition. 3) Patients who have not undergone biopsy or surgical treatment of breast lesions in this hospital, and patients with incomplete pathological data.

Design outcomes

Primary

MeasureTime frame
Deep learning model;Axillary lymph node metastasis.;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactZhou Jianhua

Sun Yat-Sen University Cancer Center

zhoujh@sysucc.org.cn+86 13711757623

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026