A Pilot Study Investigating Active Breathing Coordinator (ABC) to Reduce Radiation Dose to Normal Structures in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Proportion of Patients With Reduction in Radiation
研究概览
简要总结
The purpose of this study is to evaluate the use of a device that helps coordinate the breathing cycle in the radiation treatment of the breast in order to minimize the radiation dose to the normal structures around the breast.
详细描述
The Active Breathing Coordinator (ABC) allows for temporary and reproducible immobilization of internal thoracic structures by monitoring the patient's breathing cycle and implementing a breath hold at a predefined lung volume level. While ABC is FDA approved and commercially available, only preliminary dosimetric data is available on a small number of patients with breast cancer. There is some data using ABC for intrathoracic malignancies, which shows that it is feasible and safe to use. ABC can be used to optimize the distance between chest wall, heart and liver. This allows adequate treatment of the breast and underlying chest wall while minimizing irradiated cardiac and liver volume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requiring adjuvant or post mastectomy radiation therapy with tangential fields or 3-fields
- •Adequate pulmonary function
- •Presence of 5 cc of the heart or liver with the simulation fields
- •Karnofsky Performance Status (KPS) equal to or greater than 70
排除标准
- •Pregnant women
- •Patients who have had previous ipsilateral breast or thoracic radiation therapy
研究组 & 干预措施
Active Breathing Coordinator
Patients breathe through the ABC device
干预措施: Active Breathing Coordinator (ABC) (Device)
Active Breathing Coordinator
Patients breathe through the ABC device
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Proportion of Patients With Reduction in Radiation
时间窗: 30 days
Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues
时间窗: At time of radiation
To evaluate the magnitude of reduction in irradiated normal tissues (heart and lung) when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing. The generated dose distributions from the free-breathing vs. ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. Specifically, for the heart, the volume receiving 55 and 40 Gy will be evaluated; for the liver the volume receiving 50 and 36 Gy, and for the lung, the volume receiving 20 Gy. For the contralateral breast the volume receiving 20 Gy, 30 Gy and 50 Gy will be evaluated. Patients will be treated with the ABC device if there is at least 5 % relative reduction in the volume of a normal tissue irradiated to prescription dose.
次要结局
- Toxicity Evaluation(30 days post-treatment)
- Change in Organs at Risk (OAR) Dosimetric Paramaters(30 days post-treatment)
- Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device.(30 days post-treatment)