A prospective non-interventional multicenter cohort study to evaluate different imaging-guided methods for localization of malignant breast lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- 1. Intended target lesion and/or marker removal, independent of margin status on final
研究概览
简要总结
This is a multivcentre international observational study. The aim of the proposed study is to comparatively evaluate different imaging-guided localization methods used for surgical removal of non-palpable malignant breast lesions with regard to oncological safety and patient-reported outcomes.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Signed consent
- •Malignant breast lesion requiring breast-conserving surgery and imaging-guided localization (either DCIS or invasive breast cancer; multiple or bilateral lesions and the use of neoadjuvant chemotherapy are allowed)
- •Planned surgical removal of the lesion using one or more of the following imaging guided localization techniques (Wire, intraoperative USG, Dye, seed).
排除标准
- •Patients not suitable for surgical treatment
- •Patients requiring mastectomy as first surgery
- •Surgical removal without imaging-guided localization.
结局指标
主要结局
1. Intended target lesion and/or marker removal, independent of margin status on final
时间窗: 1. At Baseline before image-guided localisation | 2. During Surgery | 3. At 2 weeks after Surgery | 4. At 4 weeks after Surgery
histopathology
时间窗: 1. At Baseline before image-guided localisation | 2. During Surgery | 3. At 2 weeks after Surgery | 4. At 4 weeks after Surgery
2. Negative resection margin rates (defined as lesion removal with no invasive or
时间窗: 1. At Baseline before image-guided localisation | 2. During Surgery | 3. At 2 weeks after Surgery | 4. At 4 weeks after Surgery
non-invasive carcinoma on ink) at first surgery
时间窗: 1. At Baseline before image-guided localisation | 2. During Surgery | 3. At 2 weeks after Surgery | 4. At 4 weeks after Surgery
次要结局
- - Rates of second surgery, mastectomy, resection ratio, marker dislocation rates(- Volume and weight of resected tissue)
研究者
Jyoutishman Saikia
AIIMS New Delhi