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

February 18, 2026 updated by: Institute of Oncology Ljubljana

Additional Radiological 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Institute of Oncology Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breast Cancer Patients Undergoing Additional Axillary Imaging
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline imaging assessment until surgery (up to 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Oncology Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2016

Primary Completion (Actual)

October 3, 2016

Study Completion (Actual)

October 3, 2016

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OI-BC-AXLN-IMAGING-2016-312
  • ERID-KSOPKR/77 (Other Identifier: Institute of Oncology Ljubljana - KSOPKR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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