4D CT Scan With Respiratory Gating Versus 3D CT Scan Concerning Cardiac Dosimetry Assesment for Left Sided Breast Cancers Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- 3D LAD mean dose vs 4D LAD mean dose
研究概览
简要总结
To establish if the cardiac radiation dose assesment is well aproximated with routine 3D CT scan compared to 4D CT experimental scan with respiratory gating (breath motion monitoring). The study population relates to left side breast cancers female patients that require a radiation therapy treatment.
详细描述
As a standard of care, the postoperative breast cancers radiation therapy is generally based on a 3 dimensions CT scan that does not incorporate the breathing motion by definition.
Meanwhile, the patients must commonly receive the treatment in free motion breathing condition.
More of that, the Cardiac dose, especially the LAD (left anterior descending artery) dose has been established as the main cause of radiation induced ischemic heart disease (RIHD) and should be consider in the first place.
In more concrete terms, the higher the LAD dose is, the greater the RIHD relates: arise the LAD dose by 1 Gy means a 7.4% higher risk to cause a RIHD during the next 5 years.
That being said, to determine if the cardiac dosimetry and the dose-volume histograms (specifically for the left side breast cancer treatments including or not the internal mammary artery) obtained from a 3D CT scan reflect well or not the reality (which is widely subject to the breathing motion).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •Age ≥ 18 yo
- •Patients diagnoses with a left side breast cancer for which a radiation therapy is indicated and confirmed in a multidisciplinary consultation meeting.
- •Be able to understand and give her personal free consent, no judicial protection measure.
- •Written or oral consent, in compliance with the clinical investigation rules and regulation.
- •Patient affiliated with social security system
- •Treatment expected to be realized in Saint Quentin Hospital
排除标准
- •Patient < 18 yo
- •Pregnant women.
- •Breastfeeding women.
- •Consent not given
- •Claustrophobia
- •Incapacited subject or judicial protection measure
- •Other research with exclusion period time ongoing
- •All the inclusion criteria not met
结局指标
主要结局
3D LAD mean dose vs 4D LAD mean dose
时间窗: 1 week
To determine if the mean LAD (left anterior descending artery) dose significantly changes statistically between an usual 3D CT scan versus a 4D CT with breathing motion monitoring (10 breathing phases are monitored). Based on stastical test with 95% confidence intervals, to evaluate if there is a significant difference between 4D CT LAD mean dose and 3D CT LAD mean dose.
次要结局
未报告次要终点