跳至主要内容
临床试验/NCT03163316
NCT03163316已完成不适用

The Role of Unenhanced Magnetic Resonance Imaging in Quantitative Assessment of Metastatic Involvement of Axillary Lymph Nodes in Patients With Breast Cancer: Observational Descriptive Study.

Assiut University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Accuracy of unenhanced magnetic resonance imaging in assessment of axillary lymph node metastasis in breast cancer patients.

研究概览

简要总结

Breast cancer is the most common cancer among women worldwide.The main cause of cancer related death is the invasion and metastasis. The usual site of spread outside the breast is to lymph nodes in the axilla.

详细描述

The presence of axillary metastasis is important for prognosis and determining of treatment plan, so identification of axillary metastasis in early stage newly diagnosed breast cancer is important for staging of disease and treatment. However, approximately 40% of women who presents with early stage breast cancer also have axillary metastasis.

The status of lymph nodes in patients with breast cancer used to be evaluated with axillary lymph node dissection. During the last 15 years, sentinel lymph node biopsy has replaced for grading of patients with clinically lymph node negative breast cancer. Despite being a less invasive method when compared to axillary lymph node dissection, sentinel lymph node biopsy also leads to complications such as lymphedema, seroma, localized swelling, pain, paresthesia, decrease in arm strength, infectious neuropathy and shoulder stiffness in 20% of patients.

The imaging modalities for assessing the axillary lymph nodes are rapidly evolving. Ultrasound is applied widely for its convincing and dynamic observation. However, the sensitivity and specificity of ultrasound for lymph node metastasis were unreliable and controversial.

Owing to radiation and relative lower diagnostic accuracy, computed tomography is limited in clinic.

Positron emission tomography and positron emission tomography/computed tomography can reflect metabolism of glycolytic activity. Undoubtedly, they have shown the higher diagnostic significance in assessing distant metastasis and regional metastatic axillary lymph nodes, but their high radiation and expensive fee keep the common people away. Ultrasmall super paramagnetic iron oxide is the same.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

性别
Female
接受健康志愿者

入选标准

  • Patients who proved positive for primary breast cancer by histopathology with axillary lymph nodes detected clinically or with superficial ultrasound on both axillae.
  • The included lymph nodes with minimal axial diameter (4mm).

排除标准

  • Patients who have a heart pacemaker as they are absolutely contraindicated for magnetic resonance imaging.
  • Patients with severe claustrophobia. 3) Patients undergoing any type of neoadjuvant chemo-, immune- or endocrine therapy.
  • Patients with history of axillary surgery or treatment. 5) Patients with recurrent axillary disease.

结局指标

主要结局

Accuracy of unenhanced magnetic resonance imaging in assessment of axillary lymph node metastasis in breast cancer patients.

时间窗: one month

number of malignant axillary lymph nodes are accurately diagnosed by unenhanced magnetic resonance imaging in compared with histopathological result.

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

Sandy Harby

Principal Investigator

Assiut University

研究点 (2)

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