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Multimodal Ultrasound Artificial Intelligence Model for Assessing the Feasibility of Exempting Sentinel Lymph Node Biopsy in Early Breast Cancer

Multi-modal Ultrasound AI for Avoiding Sentinel Axillary Lymph Node Biopsy in Breast Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129675
Enrollment
Unknown
Registered
2026-08-07
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-08-10

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:Postoperative histopathological examination of axillary lymph nodes (including pathological results from paraffin sections of sentinel lymph node biopsy and axillary lymph node dissectio

Sponsors

Northern Jiangsu People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Female patients with pathologically confirmed breast cancer by core needle biopsy or surgical biopsy; 2.unilateral disease with maximum tumor diameter (measured by 2D ultrasound) = 2 cm; 3.candidates for planned breast-conserving surgery or total mastectomy (radiotherapy will be administered after breast-conserving surgery); 4.voluntary acceptance of preoperative multimodal ultrasound examinations including conventional grayscale ultrasound, elastography, and percutaneous/intravenous contrast-enhanced ultrasound.

Exclusion criteria

Exclusion criteria: 1.Patients with multiple fused, fixed, highly suspected metastatic lymph nodes identified on preoperative ultrasound or physical examination; 2.patients with extensive multifocal or multicentric lesions, bilateral breast cancer, or distant metastasis; 3.patients with a prior history of breast cancer or previous chest radiotherapy; 4.pregnant or lactating women; 5.patients with known allergy to ultrasound microbubble contrast agents such as Sonovue; 6.patients who are unable to complete follow-up or refuse to sign the written informed consent.

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy of multimodal ultrasound AI model for axillary lymph node metastasis prediction in breast cancer;

Countries

China

Contacts

Public ContactXiong Chunjin

Northern Jiangsu People's Hospital

yzsbxcj@163.com+86 514 8737 3037

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026