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Completed

NCT Number: NCT07418411

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Supplementary Axillary Imaging (Ultrasound Elastography and Contrast-Enhanced Ultrasound)

Diagnostic Test

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.

Primary outcomes

  1. Accuracy of Supplementary Imaging for Detecting Axillary Lymph Node Involvement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 18, 2026
Registry last updated
Feb 20, 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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