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临床试验/NCT00181363
NCT00181363已完成不适用

Mamma Board Project: Prone Breast Irradiation for Pendulous Breasts

Maastricht Radiation Oncology2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2003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
发起方
入组人数
10
试验地点
2
主要终点
Dose Homogeneity 1: PTV

研究概览

简要总结

We hypothesize that for large pendulous breasts, breast irradiation in supine and prone position are equivalent with regard to coverage of the PTV, but with a better dose homogeneity in prone position and a smaller radiation exposure of lung and heart.The purpose of this study is to compare the 3-D dose distribution in PTV(Planning Target Volume) and normal tissues in prone position versus supine position.

详细描述

Local excision followed by adjuvant radiotherapy has become standard treatment for women with early-stage breast cancer. Adjuvant radiotherapy may encounter technical difficulties in patients with pendulous breasts when treated in supine position.

Based upon literature and our own preliminary experiences, we hypothesize that for large pendulous breasts, breast irradiation in supine and prone position are equivalent with regard to coverage of the PTV, but with a better dose homogeneity in prone position and a smaller radiation exposure of lung and heart. However, no quantitative data are yet available to test this hypothesis. Therefore, the aim of our study is to compare the 3-D dose distribution in PTV and normal tissues in prone position versus supine position. For treatment in prone-position an in-house developed device, the "mammaboard" was used.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients should have had breast-conserving surgery for breast cancer or DCIS (Ductal Carcinoma in Situ)
  • No indication for radiotherapy of regional nodes
  • Large, pendulous breasts (bra size D and over)

排除标准

  • Regional radiotherapy is indicated
  • Unable to lie in prone position

结局指标

主要结局

Dose Homogeneity 1: PTV

时间窗: 1 day after treatment planning

Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) and normal tissues in prone position versus supine position

Dose Homogeneity 3: V95 %

时间窗: 1 day after treatment planning

PTV coverage (% of PTV \< 95% of prescribed dose) in prone position versus supine position

Dose Homogeneity 2: V105% and V107%

时间窗: 1 day after treatment planning

Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) in prone position versus supine position

次要结局

  • PTV Coverage in Organs at Risk: Heart V30(during treatment planning)
  • PTV Coverage in Organs at Risk: MLD (Gy)(during treatment planning)

研究者

发起方
Maastricht Radiation Oncology
申办方类型
Other
责任方
Sponsor

研究点 (2)

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