NCT02626858已完成不适用
Optimizing the Delineation of the Tumour Bed in Breast Irradiation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- the interobserver variability (IOV) (%) of the delineated Clinical Target Volume (CTV) boost (cm3) with and without the fusion of the pre-operative CT-scan.
研究概览
简要总结
The aim of the present study is:
- to verify whether the delineation of the tumour bed, based on the combination of the visible postoperative changes and the position of the surgical clips on a CT scan in treatment position acquired 1 week before the start of the radiotherapy (RT), provides an accurate localisation of the boost volume compared to the localisation of the tumour on a pre-operative CT-scan.
- to document the changes that occur in the tumour bed as seen on a CT scan as a function of the delay between surgery and radiotherapy.
- to determine the ideal number and the positioning of the clips needed to reproduce the best treatment volume for the boost.
- to propose new guidelines for tumour bed definition and delineation based on the study findings.
详细描述
Start of the study: february 2012
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
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast Cancer patients, without metastases, who will undergo breast conserving surgery and probably will receive adjuvant chemotherapy and thereafter radiotherapy.
排除标准
- •Metastases at time of diagnosis
结局指标
主要结局
the interobserver variability (IOV) (%) of the delineated Clinical Target Volume (CTV) boost (cm3) with and without the fusion of the pre-operative CT-scan.
时间窗: 2 years
the volume of the delineated CTVboost (cm3) with and without the fusion of the pre-operative CT-scan.
时间窗: 2 years
次要结局
- the correlation of the Cavity Visibility Scale (CVS) to volume changes and IOV(2 Years)
- the volume changes over time (in case of adjuvant chemotherapy)(2 years)
- the usefulness of the surgical clips assessed by the 6 observers.(2 years)
研究者
研究点 (2)
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