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临床试验/NCT06695052
NCT06695052尚未招募不适用

"Axillary Nodal Evaluation in Breast Cancer by Multimodal US"

Assiut University0 个研究点目标入组 30 人开始时间: 2024年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Evaluation of axillary LNs in Breast Cancer by Grey Scale Ultrasound

研究概览

简要总结

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.

详细描述

Breast cancer (BrCa) is the most common malignant tumor affecting women globally, with its incidence and cancer-related mortality rates continuing to rise. Accurate evaluation of the presence, extent, and status of ALNs is critical for prognosis, disease staging, and treatment planning in patients with breast cancer.

Historically, axillary lymph node dissection (ALND), followed by histopathological evaluation, was the standard method for staging breast cancer. However, ALND is associated with short- and long-term complications such as lymphedema, nerve injury, seroma formation, and infection. To reduce these risks, sentinel lymph node biopsy (SLNB) has largely replaced ALND. While SLNB is less invasive and has fewer complications, it is still associated with a risk of false-negative results. According to the American Society of Oncology Guidelines, if SLNB results are negative, no further ALND is performed, as it does not confer a survival benefit. Patients with positive SLNB results, however, undergo a "completion" ALND.

Role of Ultrasound and Color Doppler Ultrasound:

Gray-scale ultrasound (US) is a non-invasive imaging modality widely used for the preoperative evaluation of ALNs in breast cancer patients. It provides valuable morphological information and facilitates obtaining tissue samples. However, its diagnostic accuracy is operator-dependent and limited to structural features of the lymph nodes. Adding Color Doppler Ultrasound (CDU) enhances this evaluation by providing functional insights, such as assessing vascular patterns and calculating the resistive index (RI) of ALNs. Despite their potential, US and CDU exhibit highly variable sensitivity and specificity across studies, which limits their standalone diagnostic utility.

Role of Ultrasound Elastography (UE):

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Evaluation of axillary LNs in Breast Cancer by Grey Scale Ultrasound

时间窗: Baseline

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.

Evaluation of axillary LNs in Breast Cancer by Color Doppler Ultrasound

时间窗: Baseline

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.

Evaluation of axillary LNs in Breast Cancer by Elastography Ultrasound

时间窗: Baseline

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.

Comparison of Multimodal Ultrasound Findings with Histopathology Results

时间窗: Baseline

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heba Abo Elmakarem Ahmed

doctor

Assiut University

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