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NCT Number: NCT07573657

Ultrasound-Guided Core Needle Biopsy to Assess Sensitivity and Specificity of 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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Maximum cortical thickness of the lymph node (mm)

    Time frame: 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 outcomes

  1. Age

    Time frame: Baseline

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

  2. Menstrual Status

    Time frame: 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.

  3. Lymph node axial ratio

    Time frame: 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.

  4. Lymph node margin regularity

    Time frame: 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.

  5. Lymph node hilum type

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dezhi Zhang

CONTACT

[email protected]

18186876068

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Collaborators

  • Baicheng Central Hospital
  • Jilin Central General Hospital
  • Siping Central People's Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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