Clinical trial · Observational
Axillary LNs Evalution in Breast Cancer by Multimodal Us
"Axillary Nodal Evaluation in Breast Cancer by Multimodal US"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymph Node Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| multi modal Us | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Evaluation of axillary LNs in Breast Cancer by Grey Scale Ultrasound
- timeFrame
- Baseline
- description
- 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.
- measure
- Evaluation of axillary LNs in Breast Cancer by Color Doppler Ultrasound
- timeFrame
- Baseline
- description
- 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.
- measure
- Evaluation of axillary LNs in Breast Cancer by Elastography Ultrasound
- timeFrame
- Baseline
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDTsai WC, Lin CK, Wei HK, Yu BL, Hung CF, Cheng SH, Chen CM. Sonographic elastography improves the sensitivity and specificity of axilla sampling in breast cancer: a prospective study. Ultrasound Med Biol. 2013 Jun;39(6):941-9. doi: 10.1016/j.ultrasmedbio.2012.12.013. Epub 2013 Mar 7. PMID 23465139
- BACKGROUNDDeSantis CE, Ma J, Gaudet MM, Newman LA, Miller KD, Goding Sauer A, Jemal A, Siegel RL. Breast cancer statistics, 2019. CA Cancer J Clin. 2019 Nov;69(6):438-451. doi: 10.3322/caac.21583. Epub 2019 Oct 2. PMID 31577379