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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07573657

Enrollment

200

Registered

2026-05-07

Start date

2026-10-01

Completion date

2028-10-01

Last updated

2026-05-07

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

Conditions

Breast Neoplasms, Lymphatic Metastasis

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Maximum cortical thickness of the lymph node (mm)	Measurements should be performed prior to treatment initiation, with a time interval not exceeding 4 weeks between the measurement and pathological examination.	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.

Secondary

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

Contacts

CONTACTDezhi Zhang

dezhi@jlu.edu.cn18186876068

Outcome results