Breast CancerNCT07418411
Additional Imaging Methods for Assessing Axillary Lymph Node Involvement in Breast Cancer
A study testing Supplementary Axillary Imaging (Ultrasound Elastography and Contrast-Enhanced Ultrasound) in people with Breast Cancer and Axillary Lymph Node Metastasis, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Axillary Lymph Node Metastasis
- What is being tested?
- Supplementary Axillary Imaging (Ultrasound Elastography and Contrast-Enhanced Ultrasound)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSlovenia
- Study dates
- 16 Jun 2016to 3 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindications to contrast-enhanced ultrasound (if applicable)
- Inability to undergo required imaging procedures
- Withdrawal of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Supplementary Axillary Imaging (Ultrasound Elastography and Contrast-Enhanced Ultrasound)
- Keywords
- breast cancer staging, axillary lymph nodes
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Patients Undergoing Additional Axillary Imaging | Experimental | Not described Receives: Diagnostic Test: Supplementary Axillary Imaging (Ultrasound Elastography and Contrast-Enhanced Ultrasound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline imaging assessment until surgery (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start16 Jun 2016
- Primary completion3 Oct 2016
- Study completion3 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm study evaluating additional radiological imaging methods for assessing axillary lymph node involvement in breast cancer patients.
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418411
- Sponsor's protocol ID
- OI-BC-AXLN-IMAGING-2016-312
- Other IDs
- ERID-KSOPKR/77
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Radiological Methods for Assessing Axillary Lymph Node Involvement in Breast Cancer
- ClinicalTrials.gov ID
- NCT07418411
- Acronym / sponsor ID
- OI-BC-AXLN-IMAGING-2016-312
- Conditions
- Breast Cancer, Axillary Lymph Node Metastasis
- Keywords
- breast cancer staging, axillary lymph nodes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 16 Jun 2016 (actual)
- Primary completion
- 3 Oct 2016 (actual)
- Study completion
- 3 Oct 2016 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm study evaluating additional radiological imaging methods for assessing axillary lymph node involvement in breast cancer patients.
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Patients Undergoing Additional Axillary Imaging | Experimental | Diagnostic Test: Supplementary Axillary Imaging (Ultrasound Elastography and Contrast-Enhanced Ultrasound) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Contraindications to contrast-enhanced ultrasound (if applicable)
- Inability to undergo required imaging procedures
- Withdrawal of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Breast Cancer Patients Undergoing Additional Axillary Imaging |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplementary Axillary Imaging (Ultrasound Elastography and Contrast-Enhanced Ultrasound) in people with Breast Cancer and Axillary Lymph Node Metastasis, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Supplementary Imaging for Detecting Axillary Lymph Node Involvement (time frame: From baseline imaging assessment until surgery (up to 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026; AzTrials last refreshed its copy on 28 Oct 2026.