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A study to optimize decision making for axillary sentinel lymph node biopsy in breast cancer based on multimodal ultrasound radiomics combined with puncture

A study to optimize decision making for axillary sentinel lymph node biopsy in breast cancer based on multimodal ultrasound radiomics combined with puncture

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121950
Enrollment
Unknown
Registered
2026-04-07
Start date
2026-04-08
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

breast carcinoma

Interventions

Gold Standard:Intraoperative SLNB localization and frozen section analysis of SLNB
Index test:1.A risk prediction model for SLNM based on clinical-pathological and multimodal ultrasound data
2.A radiomics score based on breast ultrasound and ALN multimodal ultrasound imaging data
3.A combined diagnostic model integrating the clinical and radiomics models

Sponsors

Cancer Hospital Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Female patients with cT1-2N0M0 breast cancer; 2.Age = 18 years; 3.Patients scheduled to undergo intraoperative sentinel lymph node biopsy (SLNB); 4.Patients who voluntarily participate in the study and have provided written informed consent;

Exclusion criteria

Exclusion criteria: 1.History of prior ipsilateral breast or axillary surgery, radiotherapy, or receipt of neoadjuvant chemotherapy; 2.Patients with bilateral breast cancer; 3.Patients unable to undergo the complete ultrasound examination or needle biopsy; 4.Pregnant patients or those with a known allergy to ultrasound contrast agents; 5.Patients with incomplete clinical-pathological data or ultrasound image;

Design outcomes

Primary

MeasureTime frame
Diagnostic concordance rate of CEUS-guided biopsy of sentinel lymph nodes;Accuracy of percutaneous contrast-enhanced ultrasound (CEUS) lymphography in localizing sentinel lymph nodes (SLNs);Diagnostic performance of intravenous contrast-enhanced ultrasound (CEUS) for characterizing sentinel lymph node metastasis;

Secondary

MeasureTime frame
Contrast-enhanced ultrasound enhancement patterns of sentinel lymph nodes;

Countries

China

Contacts

Public ContactFeng Li

Cancer Hospital, Chinese Academy of Medical Sciences

fyljasmine@126.com+86 10 8778 8551

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026