NCT03801850已完成不适用
Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: Monocentric Feasibility Study MorphoBreast3D
Centre Paul Strauss2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年2月22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
- 60
- 试验地点
- 2
- 主要终点
- Impact of breast morphology or volume changes during the breast irradiation on the total dose administered
研究概览
简要总结
Quantitative evaluation of the breast's morphological variations during radiotherapy consisting in performing three-dimensional surface acquisitions of the breast in order to study its shape and volume. Evaluation of the dosimetric impact of these variations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •In situ or invasive breast carcinoma
- •Treated by conservative breast surgery
- •Pre-treatment with authorized chemotherapy
- •Eligible for conventional breast irradiation in 25 sessions of 2 Gy with or without irradiation of the tumor bed and lymph nodes area
- •Conventional 3D radiotherapy technique
- •Bra cup size from A to D included
- •Speaking and understanding french
- •Having given written consent
- •Patient with health insurance
排除标准
- •Surgical treatment by mastectomy
- •No indication for breast radiotherapy
- •Local or diffuse inflammatory state of the breast at inclusion
- •History of epilepsy or anticonvulsive treatment for preventive or curative purposes
- •BMI> 30kg / m2
- •T4 stage tumor
- •Bilateral breast tumor
- •Use of a ventilatory control to treat the patient
- •Minor patient or major incompetent
- •Patient deprived of liberty
- •Patient under safeguard of justice
结局指标
主要结局
Impact of breast morphology or volume changes during the breast irradiation on the total dose administered
时间窗: Change of the dose delivered in the breast from the baseline treatment planification at the end of the treatment (at 5 weeks for in-situ carcinoma and at 6.5 weeks for invasive carcinoma)
To analyse the effect of morphological changes in the breast during breast radiotherapy on the dose really administered in the remaining mammary gland after breast-conserving surgery compared to the dose initially planned.
次要结局
- Preliminary quantitative assessment of breast volume changes (mL) during breast radiotherapy following breast cancer conservative surgery(At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33))
- Correlation between textural data and radio-induced erythema(At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33))
- Preliminary quantitative assessment of breast deformations (mm) during breast radiotherapy following breast cancer conservative surgery(At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33))
- Breast deformation and volume measurements reproducibility(before treatment start)
- Deviation between the breast volume calculated and the breast volume manually delineated(before treatment start)
- Potential dose distribution alteration despite no variation of the 95Recalculated or the D2Recalculated(at the end of each treatment (at 5 weeks for in-situ carcinoma and at 6.5 weeks for invasive carcinoma))
- Required measurement time (surface scan)(At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33))
研究者
研究点 (2)
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