Axillary LNs Evalution in Breast Cancer by Multimodal Us

NCT06695052 | Not Yet Recruiting

• 1 other identifier: Axillary LNs in BC by multi US
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Breast Cancer; Lymph Node Metastasis

Keywords

breast cancer; Lymph Node Metastasis; multimodal ultrasound

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

Interventions

multi modal Us DEVICE

Greyscale US: grey scale ultrasound Color Doppler US: Color Doppler ultrasound Elastography US: Elastography ultrasound

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients with primary breast cancer and metastatic axillary LNs

You may qualify if:

• \- 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 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Tsai 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 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

MeSH Terms

Conditions

Breast Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Abul Hassan H Mohammed, AP.radiology

  Assiut University

  STUDY DIRECTOR

• Sara M Ahmed, AP.radiology

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Heba Abo EM Ahmed, AL.Radiology

CONTACT

+01122112561; hoobamakarem@gmail.com

Nagham N Omar, P. Radiology

CONTACT

+201028820041; nagham.omar@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 19, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11