Magnetic Resonance Imaging in RadiotheRapy fOr bReast Cancer (MIRROR): A Pilot Study of MRI Simulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percentage of participants who completed scan
研究概览
简要总结
This is a single-center, prospective pilot study evaluating feasibility and efficacy of incorporating magnetic resonance imaging (MRI) simulation into the planning of radiation treatment (RT) for breast cancer.
详细描述
PRIMARY OBJECTIVE:
I. To determine feasibility of acquiring MRI simulation prior to RT planning.
EXPLORATORY OBJECTIVE:
I. To determine change in target volume with MRI simulation compared to Computerized tomography (CT) simulation.
OUTLINE: MRI simulation will be performed once at baseline. There is no follow up planned for study purposes. Patients will be followed as part of their regular clinical care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participants with an Eastern Cooperative Oncology Group (ECOG) performance status <=2 (or Karnofsky ≥>=60%, see Appendix A).
- •Participants with the ability to understand and the willingness to sign a written informed consent document.
- •Participants may separately enroll on therapeutic clinical trials when they enroll on this trial. Note: All interventions on this protocol are standard of care, so enrollment on other therapeutic protocols is allowed at the discretion of the treating physician.
- •Patients must have pathologically confirmed invasive or in situ breast cancer.
- •Patients must have tumors in which adjuvant breast radiotherapy following breast conserving surgery is indicated, as determined by the treating physician.
- •Patients must be female. Note: Male patients are excluded due to the rarity of male breast cancer and difficulty in pursuing breast conserving surgery for male patients.
排除标准
- •Participants with a contraindication to MRI per the MRI checklist.
- •Patients with breast tumor or tumor bed not visualized at CT or MRI during RT planning.
结局指标
主要结局
Percentage of participants who completed scan
时间窗: Day of MR imaging (1 day)
Feasibility feasibility of acquiring MRI simulation prior to RT planning is defined as successfully acquiring MRI data at the specified time point in a participant's radiotherapy (RT) care plan
次要结局
未报告次要终点