NCT07418411

Additional Imaging Methods for Assessing Axillary Lymph Node Involvement in Breast Cancer

Additional Radiological Methods for Assessing Axillary Lymph Node Involvement in Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Institute of Oncology Ljubljana · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Breast cancer frequently spreads to the axillary lymph nodes, and accurate assessment of axillary lymph node involvement is essential for staging and treatment planning. Standard imaging methods may not always reliably determine the extent of axillary disease before treatment. This study evaluates the usefulness of additional radiological imaging methods for assessing axillary lymph node involvement in patients with breast cancer. The aim is to improve pre-treatment identification of lymph node metastases and to better estimate the extent of axillary disease.

Detailed description

Accurate evaluation of axillary lymph node involvement is a key component of breast cancer staging and influences surgical and systemic treatment decisions. Current routine diagnostic methods, including standard ultrasound and other imaging techniques, may have limited sensitivity and specificity in detecting and characterizing axillary lymph node metastases. This interventional clinical study investigates whether additional radiological imaging methods can improve the assessment of axillary lymph node involvement in breast cancer patients. Participants undergo supplementary radiological examinations of the breast and axilla beyond routine diagnostic procedures. These examinations are performed in order to evaluate the diagnostic performance of additional imaging techniques in determining the presence and extent of axillary lymph node disease. The study is designed as a prospective cohort study and includes patients diagnosed with breast cancer who are undergoing clinical evaluation and treatment at the Institute of Oncology Ljubljana. The primary objective is to determine whether the additional radiological methods provide improved accuracy for detecting axillary lymph node involvement compared with standard diagnostic assessment. The results of this study may support improved diagnostic pathways and assist clinicians in selecting the most appropriate therapeutic strategy for breast cancer patients.

Conditions

• Breast Cancer
• Axillary Lymph Node Metastasis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Supplementary Axillary Imaging (Ultrasound Elastography and Contrast-Enhanced Ultrasound)	Participants will undergo additional radiological imaging of the breast and axilla using ultrasound elastography and contrast-enhanced ultrasound in order to assess the presence and extent of axillary lymph node involvement in breast cancer. These supplementary imaging methods are performed in addition to routine diagnostic evaluation.

Timeline

• Start date: 2016-06-16
• Primary completion: 2016-10-03
• Completion: 2016-10-03
• First posted: 2026-02-18
• Last updated: 2026-02-20

Locations

1 site across 1 country: Slovenia