Axillary Lymph Node Metastasis, Breast Cancer
Conditions
Keywords
breast cancer staging, axillary lymph nodes
Brief 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.
Interventions
DIAGNOSTIC_TESTSupplementary 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.
Sponsors
Institute of Oncology Ljubljana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Single-arm study evaluating additional radiological imaging methods for assessing axillary lymph node involvement in breast cancer patients.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients aged 18 years or older * Diagnosed with breast cancer * Undergoing diagnostic evaluation and treatment at the Institute of Oncology Ljubljana * Ability to provide written informed consent
Exclusion criteria
* Contraindications to contrast-enhanced ultrasound (if applicable) * Inability to undergo required imaging procedures * Withdrawal of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Supplementary Imaging for Detecting Axillary Lymph Node Involvement | From baseline imaging assessment until surgery (up to 6 months) | Diagnostic accuracy of supplementary ultrasound-based imaging methods (elastography and contrast-enhanced ultrasound) for identifying axillary lymph node involvement in breast cancer patients, compared with standard clinical and pathological assessment. |
Countries
Slovenia
Outcome results
None listed