Ultrasound-Guided Core Needle Biopsy to Assess Sensitivity and Specificity of Axillary Lymph Node Metastasis in Breast Cancer

NCT07573657 | Not Yet Recruiting

• 1 other identifier: 25K072-001
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study plans to find the most suitable lymph node cortex thickness and abnormal lymph node features to define suspicious lymph nodes. Then, ultrasound-guided core needle biopsy of axillary lymph nodes will be done, aiming to provide some guidance for the biopsy.

Conditions

Lymphatic Metastasis; Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Maximum cortical thickness of the lymph node (mm)

  The maximum thickness of the lymph node's cortical layer. Measured via conventional ultrasound examination of the lymph node's long-axis cross-section, perpendicular to the capsule surface, determining the maximum distance from the capsule to the corticomedullary junction.

  Measurements should be performed prior to treatment initiation, with a time interval not exceeding 4 weeks between the measurement and pathological examination.

Secondary Outcomes (5)

• Age

  Baseline

• Menstrual Status

  At initial diagnosis of primary breast cancer

• Lymph node axial ratio

  Measurements should be performed prior to treatment initiation, with a time interval not exceeding 4 weeks between the measurement and pathological examination.

• Lymph node margin regularity

  Measurements should be performed prior to treatment initiation, with a time interval not exceeding 4 weeks between the measurement and pathological examination.

• Lymph node hilum type

  Within 4 weeks before pathological examination and prior to treatment initiation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients newly diagnosed with primary breast cancer and assessed for axillary lymph node metastasis by ultrasound, prospectively enrolled from November 2025 to November 2026 across multiple hospitals.

You may qualify if:

• Age ≥18 years and \<70 years;
• Histologically confirmed primary breast cancer;
• Underwent ultrasound examination to assess axillary lymph node metastasis status.

You may not qualify if:

• Presence of other malignancies (e.g., lymphoma, lung cancer, thyroid cancer, etc., with axillary metastasis);
• Pregnant or lactating women;
• Previous receipt of neoadjuvant radiotherapy or chemotherapy;
• Lymph node metastasis status not confirmed by pathology, or time interval between ultrasound examination and pathological confirmation exceeding 6 weeks.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead
• Siping Central People's Hospital: collaborator
• Baicheng Central Hospital: collaborator
• Jilin Central General Hospital: collaborator

MeSH Terms

Conditions

Lymphatic Metastasis; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Dezhi Zhang

CONTACT

18186876068; dezhi@jlu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (PI)

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share