NCT04343079招募中不适用
Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- investigate the ability of (micro)PET/CT to evaluate the excision margins and determine negativity of these margins, as compared to the gold standard of sectional histopathological evaluation.
研究概览
简要总结
Examination of the feasibility of intra-operative pet CT to detect surgical margins in breast conservative surgery to prevent re-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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• female and 18 years of age or older
- •diagnosed with an early-stage (T1 or T2, and N0 or N1; according to the TNM-classification) invasive breast cancer
- •eligible for breast conserving surgery
排除标准
- •• Pregnancy or lactation
- •Multifocal tumor disease
- •Diagnosis of inflammatory breast cancer
- •Appointment at the nuclear medicine department for 18F-FDG administration would result in a unacceptable delay of surgery
- •Subject has had exposure to ionizing radiation of more than 1 mSv in other research studies within the last 12 months
- •Subject has recently (<60 days) or is simultaneously participating in another clinical trial.
结局指标
主要结局
investigate the ability of (micro)PET/CT to evaluate the excision margins and determine negativity of these margins, as compared to the gold standard of sectional histopathological evaluation.
时间窗: 2 year
study the feasibility of PET/CT
次要结局
未报告次要终点
研究者
研究点 (2)
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