Intra-patient Comparison of Active Breathing Coordinator-based vs VisionRT-based Deep Inspiration Breath-hold for Left-chest Wall Irradiation, a Pilot Study for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Residual Motion During Deep Inspiratory Breath-Hold (DIBH)
研究概览
简要总结
Female patients treated with radiation for left-sided breast malignancy will undergo alternate fractions of Active Breathing Coordinator (ABC)-assisted and VisionRT-assisted Deep Inspiration Breath-Hold (DIBH).
详细描述
Female patients treated with radiation for left-sided breast malignancy will undergo alternate fractions of ABC-assisted and VisionRT-assisted DIBH. Residual motion during breath-hold will be quantitatively assessed using MV fluoroscopy from the treatment beam itself (i.e., no additional radiation dose). The dosimetric impact of residual motion on organs at risk (heart and lung) will be assessed by applying rigid and/or deformable displacements to the planning CT images, computing the 3D dose map and comparing with the original planned dose map.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with diagnosis of breast malignancy
- •Women whom requires left chest wall post-mastectomy radiation with or without bolus
- •Age ≥ 18 years.
- •Performance status ECOG </=3
- •Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Ability to understand and the willingness to sign a written informed consent.
- •Patient must be able to maintain a 30 second breath hold.
- •Conventional chest wall radiation delivery dose of 50.4 Gy/ 28 fractions with or without a boost (boost will not be evaluated for endpoints)
排除标准
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
研究组 & 干预措施
ABC (Active Breathing Coordinator ), Then VRT
Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-assisted DIBH, followed by 14 fractions with VRT-assisted DIBH
干预措施: Active Breathing Coordinator (ABC) (Device)
ABC (Active Breathing Coordinator ), Then VRT
Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-assisted DIBH, followed by 14 fractions with VRT-assisted DIBH
干预措施: VisionRT (Device)
VisionRT (VRT), Then ABC
VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-assisted DIBH, followed by 14 fractions with ABC-assisted DIBH
干预措施: Active Breathing Coordinator (ABC) (Device)
VisionRT (VRT), Then ABC
VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-assisted DIBH, followed by 14 fractions with ABC-assisted DIBH
干预措施: VisionRT (Device)
结局指标
主要结局
Residual Motion During Deep Inspiratory Breath-Hold (DIBH)
时间窗: All patients received treatment for 2 hours for a minimum of 6 weeks
Residual motion is measured as range of breast/chest wall motion during the ABC or VisionRT assisted DIBH beam delivery. The range of motion will be measured in a unit of millimeter.
次要结局
- Time of Simulation(All patients received treatment for 2 hours for a minimum of 6 weeks)
- Time of Treatment in Minutes(All patients received treatment for 2 hours for a minimum of 6 weeks)
- Reproducibility as Measure of Absolute Change of Breathing Chest Wall Excursion(All patients received treatment for 2 hours for a minimum of 6 weeks)
- Radiation Dose to Heart(All patients received treatment for 2 hours for a minimum of 6 weeks)
- Radiation Dose to Lung(All patients received treatment for 2 hours for a minimum of 6 weeks)
研究者
Asal Rahimi
ASSOC PROFESSOR, Radiation Oncology - RO-Radiation Oncology
University of Texas Southwestern Medical Center