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

N/ANot Yet RecruitingNCT07573657

The First Hospital of Jilin University200 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Lymphatic Metastasis Breast Neoplasms

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Age

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Central Contacts

Dezhi Zhang

CONTACT

18186876068 dezhi@jlu.edu.cn

Data from ClinicalTrials.gov

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