About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial population
Female patients with primary breast cancer and metastatic axillary LNs
Trial design
Cohort
Prospective
Treatments tested in this trial
multi modal Us
DeviceGreyscale US: grey scale ultrasound Color Doppler US: Color Doppler ultrasound Elastography US: Elastography ultrasound
Treatment groups
Trial outcomes
Primary outcomes
Evaluation of axillary LNs in Breast Cancer by Grey Scale Ultrasound
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.
Evaluation of axillary LNs in Breast Cancer by Color Doppler Ultrasound
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.
Evaluation of axillary LNs in Breast Cancer by Elastography Ultrasound
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.
Comparison of Multimodal Ultrasound Findings with Histopathology Results
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.
Locations
Sponsors and contacts
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