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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Neoplasms; Lymphatic Metastasis

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Dezhi Zhang; Phone Number: 18186876068; Email: dezhi@jlu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age of participants at the time of initial diagnosis of primary breast cancer, reported in years.	Baseline
Menstrual Status	Menstrual status at initial diagnosis of primary breast cancer, assessed by medical record review and categorized as premenopausal, perimenopausal, postmenopausal, or unknown.	At initial diagnosis of primary breast cancer
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.	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	Categorized as either regular or irregular.	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	Lymph node hilum type assessed on pre-treatment imaging, categorized according to the presence or absence of the lymph node hilum.	Within 4 weeks before pathological examination and prior to treatment initiation

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University
• Collaborators: Siping Central People's Hospital; Jilin Central General Hospital; Baicheng Central Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: May 1, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplastic Processes; Skin Diseases; Breast Diseases; Neoplasm Metastasis; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Breast Neoplasms; Lymphatic Metastasis
• Other Study ID Numbers: 25K072-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No