Clinical trial · Observational
Multimodal Ultrasonographic Assessment of Ipsilateral Axillary Lymph Nodes in Patients With Breast Cancer: A STARD Study
- 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)
Breast cancer (BrCa) is the most common malignant neoplasm in women worldwide with a continuous rise on both its incidence and cancer-related deaths. Accurate evaluation of the presence, extent and status (benign or malignant) of axillary lymph nodes (ALNs) in patients with BrCa has an important prognostic value, and is essential for disease staging and treatment planning. Many radiological diagnostic modalities have been utilized to assess the nature of ALNs in the pre-operative stage. Each modality has its weaknesses and strengths. Multimodal imaging combines two or more imaging modalities into one system to produce details in clinical diagnostic imaging that are more precise than any conventional imaging alone. Therefore, the present study is designed to assess the role of simultaneous multi-modal sonographic tools \[conventional grey-scale ultrasound; US, Color-Doppler ultrasound; CDU, strain ultrasound elastography; UE) in evaluating the nature (benign or malignant) of ipsilateral ALNs in patients with primary BrCa together with comparing the diagnostic indices of each with that of all-together (combined modalities). A total of 30 patients with BrCa and US-visible ALNs will be included. All will be subjected to simultaneous examination by US, CDU, UE and US-guided FNA cytology examination of their ipsilateral ALNs. Data will be collected and analyzed using SPSS version 23. Area under the receiver Operating Characteristic (ROC) curve will be calculated and the diagnostic indices of each modality and of all modalities will be measured.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multimodal Ultrasonographic Assessment of Axillary Lymph Nodes in Patients With Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal Ultrasound | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluate the role of Strain Elastography and other US modalities
- timeFrame
- 6-8 month
- description
- Assessment of the role of multimodal ultrasonography in diagnosis/recognition of the nature of ALNs (benign or malignant) in patients with 1ry BrCa.
Secondary outcomes (1)
- measure
- Develop a Scoring system
- timeFrame
- 6-8 month
- description
- Using the 4 modalities, a scoring system will be generated to predict the nature of ALNs (malignancy)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Female 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 BrCa Patients exposed to loco-regional radio- or chemotherapy Patients with previous axilla surgery Presence of Distant metastasis (Liver, Bone, Lung) Patients who deny or refuse to participate in the study
References
Publications (3)
- BACKGROUNDSiegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34. doi: 10.3322/caac.21551. Epub 2019 Jan 8. PMID 30620402
- 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
- BACKGROUNDBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593