NCT01432002进行中（未招募）不适用
Application of 18F-[FDG] PET/CT to Simulation and Planning of Radiotherapy (RT) for Breast Cancer. Definition of Target Volume for 3-D RT and for Partial Breast Irradiation (PBI) by IMRT Technique
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Drawing of target volumes
研究概览
简要总结
The purpose of the study is:
- to assess the potential benefits of 18F-[FDG] PET/CT and PET/MRI for operable breast cancer in order to define the size and location of the primary tumor, as well as axillary, supraclavicular and internal mammary lymph nodes.
- to apply the imaging results to the simulation and the radiation treatment planning and partial breast for 3-D radiation treatment and partial breast irradiation with intensity modulated radiation treatment (IMRT).
详细描述
Pre-operative FDG PET/CT, and in option PET/IRM, are intended for women with histologically confirmed operable clinically node-negative breast cancer, in whom breast conserving and post-operative radiotherapy are planned.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed breast carcinoma
- •Clinical stage T1-2 N0 M0
- •Age > 18 years
- •Signed informed consent
排除标准
- •WHO performance index 3
- •Premenopausal women without contraception
- •Gestation
- •Lactating
- •Prior surgery or radiotherapy on the same breast
- •Unable to understand study participation
- •Bilateral breast cancer
- •Prior CT thorax-abdomen and breast MRI within 4 months of interview
- •Presence of electromechanical implant and/or body ferromagnetic material
- •Previous history of renal insufficiency requiring dialysis and/or hospitalisation
- •Ureum and/or creatinine within 2 weeks of interview above lab's reference limits
- •History of contrast allergy
- •Hyperthyroidy
- •Claustrophobia.
结局指标
主要结局
Drawing of target volumes
时间窗: Up to 12 weeks after surgery
Compare the drawing of target volumes using the PET/CT, PET/IRM information, or without these imaging informations.
次要结局
- Correlate the FDG PET/CT PET/IRM with surgical pathology findings(Up to 12 weeks after surgery)
研究者
Vincent Vinh-Hung
Privat Docent
University of Geneva, Switzerland
研究点 (1)
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