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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-70
SponsorThe First Hospital of Jilin University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years and <70 years;

Histologically confirmed primary breast cancer;

Underwent ultrasound examination to assess axillary lymph node metastasis status.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

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

Secondary outcomes

1

Age

Age of participants at the time of initial diagnosis of primary breast cancer, reported in years.

Time frame
Baseline
2

Menstrual Status

Menstrual status at initial diagnosis of primary breast cancer, assessed by medical record review and categorized as premenopausal, perimenopausal, postmenopausal, or unknown.

Time frame
At initial diagnosis of primary breast cancer
3

Lymph node axial ratio

The ratio of the maximum longitudinal diameter to the maximum transverse diameter of the lymph node. The maximum longitudinal diameter and maximum transverse diameter of the lymph node are measured separately, and the axial ratio is obtained by dividing the measured longitudinal diameter value by the transverse diameter value.

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

Lymph node margin regularity

Categorized as either regular or irregular.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Hospital of Jilin University

Lead sponsor

Siping Central People's Hospital

Collaborator

Baicheng Central Hospital

Collaborator

Jilin Central General Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: