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

NCT07418411 | Completed

• 2 other identifiers: OI-BC-AXLN-IMAGING-2016-312ERID-KSOPKR/77
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Axillary Lymph Node Metastasis

Keywords

breast cancer staging; axillary lymph nodes

Outcome Measures

Primary Outcomes (1)

• Accuracy of Supplementary Imaging for Detecting Axillary Lymph Node Involvement

  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)

Study Arms (1)

Breast Cancer Patients Undergoing Additional Axillary Imaging

EXPERIMENTAL

Diagnostic Test: Supplementary Axillary Imaging (Ultrasound Elastography and Contrast-Enhanced Ultrasound)

Interventions

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.

Breast Cancer Patients Undergoing Additional Axillary Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindications to contrast-enhanced ultrasound (if applicable)
• Inability to undergo required imaging procedures
• Withdrawal of informed consent

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm study evaluating additional radiological imaging methods for assessing axillary lymph node involvement in breast cancer patients.

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: June 16, 2016
• Primary Completion: October 3, 2016
• Study Completion: October 3, 2016
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)