Ultrasound Guided Core Needle Biopsy Versus Fine Needle Aspiration of Morphologically Abnormal Axillary Lymph Node in Patients With New Diagnosis or Suspected Diagnosis of Invasive Breast Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Accuracy of FNA and CNB
研究概览
简要总结
To compare accuracy of ultrasound guided fine needle aspiration (FNA) to core needle biopsy (CNB) of ultrasound detected abnormal axillary lymph nodes in patients with newly diagnosed invasive breast cancer or suspected invasive breast cancer.
Hypothesis: FNA and CNB have equivalent diagnostic accuracies
In order to prove our hypothesis, we will perform FNA and CNB on the same lymph node in each consented patient. The two samples will be evaluated separately by different pathologists blinded to the material in the other sample.
The results of the biopsies will be compared to the gold standard (lymph node excision).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent or suspected diagnosis of invasive breast cancer with abnormal ipsilateral axillary lymph node
- •Able to provide informed consent
排除标准
- •Lymph node not amenable to core biopsy
- •Patient is unlikely to undergo lymph node excision (i.e. elderly patient with co-morbidities)
研究组 & 干预措施
Abnormal lymph nodes
There is only one arm to this study and includes all eligible and consented patients with abnormal axillary lymph node on ultrasound.
干预措施: FNA and Core biopsy (Procedure)
结局指标
主要结局
Accuracy of FNA and CNB
时间窗: 2 years
Accuracy will be determined by comparing the results of the FNA and CNB performed on the same lymph node to the gold standard using a paired test of equivalence. The gold standard is the final pathologic diagnosis of excised lymph node containing biopsy marker (either sentinel lymph node biopsy or axillary dissection). Surgical excision of pre-operatively sampled lymph node marks the end of study participation for each patient.
次要结局
- Pain associated with FNA and CNB(2 years)