Assessment of Left-sided Cardiac Sparing Through the Use of 3-dimensional Surface Matching-based Deep Inspiration Breath Hold and Active Breathing Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Reproducibility of ABC or vDIBH set-up as measured by Align RT.
研究概览
简要总结
The standard treatment for breast cancer is surgery followed by adjuvant breast radiation therapy in most cases. For left sided breast cancers, the heart dose delivered by the radiation treatment is often of particular concern. In order to spare the heart, different strategies are currently available, including active breathing control (ABC) and voluntary deep in inspiration breath hold (DIBH) (both strategies are currently being used at our centre). To perform accurate heart-sparing treatments, it is important to ensure that patients are positioned consistently. One available approach is through surface imaging which tracks the position of a portion of the skin surface, known as the AlignRT system (VisionRT Ltd, London, UK).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Women with diagnosis of left-sided breast malignancy
- •Women who require left chest wall or breast irradiation status post mastectomy or lumpectomy
- •Treatment with modified wide tangents to include IMCs
- •Treatment with four-field technique
- •Age >18 years
- •Performance status ECOG <3
- •Patient must be able to maintain a 30 second breath hold
- •Conventional chest wall or breast radiation delivery dose of 50Gy/25 or hypofractionated chest wall/breast radiation delivery dose of 42.56Gy/16 with or without a boost
排除标准
- •Right sided breast cancer patients
- •Treatment with partial breast irradiation
- •Previous left breast/chest wall irradiation
- •Locally advanced breast cancer
- •Pregnant patients
- •Unable to follow commands
结局指标
主要结局
Reproducibility of ABC or vDIBH set-up as measured by Align RT.
时间窗: 2 years
Reproducibility of set-up will be evaluated by determining discrepancies in patient's surface between treatment and CT simulation which will be acquired with the Align RT system using multiple measures along with daily portal images during treatment and weekly CBCTs.
Mean heart dose as determined using Align RT.
时间窗: 2 years
Estimate the change in mean heart dose for each breath-hold/heart sparing strategy by: i. Converting differences in heart position on 2D portal images acquired during treatment to 3D volumes on Pinnacle plans. ii. Using the CBCT images (acquired weekly), to recalculate dose to heart based on the patient's position and anatomy that day.
次要结局
- The impact of Align RT with vDIBH as compared to vDIBH without AlignRT on quality of life as assessed by the EORTC core QoL questionnaire.(2 years)
研究者
Dr. Irene Karam
Radiation Oncologist
Sunnybrook Health Sciences Centre