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

NCT04549558 | Unknown

• 1 other identifier: AssiutU AAHelmy
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Multimodal Ultrasonographic Assessment of Axillary Lymph Nodes in Patients With Breast Cancer

Keywords

Strain Elastography, Grey-Scale Ultrasound, Carcinoma, Nodal, Axilla, Color-Doppler,

Outcome Measures

Primary Outcomes (1)

• Evaluate the role of Strain Elastography and other US modalities

  Assessment of the role of multimodal ultrasonography in diagnosis/recognition of the nature of ALNs (benign or malignant) in patients with 1ry BrCa.

  6-8 month

Secondary Outcomes (1)

• Develop a Scoring system

  6-8 month

Interventions

Multimodal Ultrasound DIAGNOSTIC_TEST

Multimodal Ultrasound (Strain Ultrasound Elastography, Conventional Grey-Scale Ultrasound, Color-Doppler Ultrasound, and Ultrasound Guided Fine Needle Aspirate) on Axillary Lymph Nodes

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive female patients with primary breast cancer (BrCa) and axillary lymph nodes (ALNs) of unknown nature (benign or malignant) referred to the Department of Diagnostic Radiology for pre-operative assessment of presence, extent and nature of ALNs.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Siegel 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 BACKGROUND

• DeSantis 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 BACKGROUND

• Bray 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 BACKGROUND

MeSH Terms

Conditions

Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: May 15, 2022
• Primary Completion: May 15, 2023
• Study Completion: June 15, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-03