Axillary LNs Evalution in Breast Cancer by Multimodal Us

November 17, 2024 updated by: Heba Abo Elmakarem Ahmed, Assiut University

"Axillary Nodal Evaluation in Breast Cancer by Multimodal US"

The present study is designed to evaluate the role of simultaneous multi-modal sonographic tools-Ultrasound (US), Color Doppler Ultrasound (CDU), and Ultrasound Elastography (UE)-in determining the nature (benign or malignant) of axillary lymph nodes (ALNs) in patients with primary breast cancer. It aims to compare the diagnostic indices of each modality individually against their combined performance. Specifically, the study will assess whether adding UE to conventional gray-scale US and CDU improves diagnostic accuracy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast cancer (BrCa) is the most common malignant tumor affecting women globally, with its incidence and cancer-related mortality rates continuing to rise. Accurate evaluation of the presence, extent, and status of ALNs is critical for prognosis, disease staging, and treatment planning in patients with breast cancer.

Historically, axillary lymph node dissection (ALND), followed by histopathological evaluation, was the standard method for staging breast cancer. However, ALND is associated with short- and long-term complications such as lymphedema, nerve injury, seroma formation, and infection. To reduce these risks, sentinel lymph node biopsy (SLNB) has largely replaced ALND. While SLNB is less invasive and has fewer complications, it is still associated with a risk of false-negative results. According to the American Society of Oncology Guidelines, if SLNB results are negative, no further ALND is performed, as it does not confer a survival benefit. Patients with positive SLNB results, however, undergo a "completion" ALND.

Role of Ultrasound and Color Doppler Ultrasound:

Gray-scale ultrasound (US) is a non-invasive imaging modality widely used for the preoperative evaluation of ALNs in breast cancer patients. It provides valuable morphological information and facilitates obtaining tissue samples. However, its diagnostic accuracy is operator-dependent and limited to structural features of the lymph nodes. Adding Color Doppler Ultrasound (CDU) enhances this evaluation by providing functional insights, such as assessing vascular patterns and calculating the resistive index (RI) of ALNs. Despite their potential, US and CDU exhibit highly variable sensitivity and specificity across studies, which limits their standalone diagnostic utility.

Role of Ultrasound Elastography (UE):

Real-time strain ultrasound elastography (UE) is an advanced imaging technique that measures tissue stiffness, a property often associated with malignancy. Unlike US and CDU, UE can quantify stiffness, providing additional diagnostic insights. Elastography utilizes rhythmic manual compression to produce color-coded elastograms, which display differences in tissue stiffness. These elastograms are generated alongside conventional gray-scale US to ensure precise imaging of the same lymph node. Although UE has been explored for ALN assessment, existing studies report inconsistent results.

Recent meta-analyses suggest that UE offers valuable supplementary information for preoperative ALN evaluation and may influence surgical decision-making.

Other Imaging Modalities:

Alternative imaging techniques, including mammography, magnetic resonance imaging (MRI), multi-detector computed tomography (CT), and positron-emission tomography (PET-CT), have also been employed for ALN assessment. However, their widespread application is limited by moderate sensitivity, low specificity, high costs, radiation exposure, and the need for specialized imaging protocols for ALNs.

Multimodal Imaging:

Multimodal imaging, which combines two or more imaging techniques, provides a more comprehensive diagnostic approach than individual modalities alone. This study investigates the combined use of gray-scale US, CDU, and UE to improve diagnostic accuracy for ALN assessment in breast cancer patients.

This version addresses the study's purpose, methodology, and the role of each modality in greater detail

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

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

Study Contact

Study Contact Backup

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female patients with primary breast cancer and metastatic axillary LNs

Description

Inclusion Criteria:

- Patients with primary breast cancer (BrCa) and axillary lymph nodes (ALNs) referred to the Department of Diagnostic Radiology for pre-operative assessment of presence, extent and nature of ALNs.

Exclusion Criteria:

  • Patients with secondary or recurrent Breast Ca
  • Patients exposed to loco-regional radio- or chemotherapy
  • Patients with previous axilla surgery
  • ± Patients with confirmed metastatic tumor to bone, liver and/or lungs
  • Patients who deny or refuse to participate in the study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of axillary LNs in Breast Cancer by Grey Scale Ultrasound
Time Frame: Baseline
Evaluate axillary lymph nodes (LNs) in breast cancer patients using grey scale ultrasound to assess specific characteristics such as size, shape, and cortical thickening. Results will be compared to Fine Needle Aspiration Cytology (FNAC) or histopathology findings.
Baseline
Evaluation of axillary LNs in Breast Cancer by Color Doppler Ultrasound
Time Frame: Baseline
Evaluate axillary lymph nodes (LNs) in breast cancer patients using color Doppler ultrasound to assess vascularity patterns. Results will be compared to FNAC or histopathology findings.
Baseline
Evaluation of axillary LNs in Breast Cancer by Elastography Ultrasound
Time Frame: Baseline
Evaluate axillary lymph nodes (LNs) in breast cancer patients using elastography ultrasound to measure stiffness and elasticity. Results will be compared to FNAC or histopathology findings.
Baseline
Comparison of Multimodal Ultrasound Findings with Histopathology Results
Time Frame: Baseline
Compare the findings from grey scale ultrasound, color Doppler ultrasound, and elastography ultrasound with histopathology results to assess diagnostic accuracy for evaluating axillary lymph nodes in breast cancer.
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Abul Hassan H Mohammed, AP.radiology, Assiut University
  • Study Director: Sara M Ahmed, AP.radiology, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

November 20, 2024

Primary Completion (Estimated)

November 20, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 17, 2024

First Posted (Estimated)

November 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 17, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Axillary LNs in BC by multi US

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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