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NCT04549558

Multimodal Ultrasonographic Assessment of Ipsilateral Axillary Lymph Nodes in Patients With Breast Cancer: A STARD Study

Status unknown Last updated 31 March 2022
What this trial tests

trial testing Multimodal Ultrasound in Multimodal Ultrasonographic Assessment of Axillary Lymph Nodes in Patients With Breast Cancer in 30 participants. Status unknown.

Timeline
15 May 2022
Primary endpoint
15 May 2023
15 June 2023

Quick facts

Lead sponsorAssiut University
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment30
Start date15 May 2022
Primary completion15 May 2023
Estimated completion15 June 2023

Drugs / interventions tested

Conditions studied

Sponsor

Assiut University

Who can join

Adults 18 to 80, female only, with Multimodal Ultrasonographic Assessment of Axillary Lymph Nodes in Patients With Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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