跳至主要内容
临床试验/NCT03878485
NCT03878485已完成不适用

Pilot Study of Same-session MR-only Simulation and Treatment With Stereotactic MRI-guided Adaptive Radiotherapy (SMART) for Oligometastases of the Spine

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Number of Participants to Receive Delivery of the First Fraction of Same-session MRI-only Simulation and Treatment With SMART on the First On-table Attempt

研究概览

简要总结

In light of the increasing experience with magnetic resonance image-guided radiotherapy (MRgRT) and adaptive planning and advances in magnetic resonance (MR)-only planning, the investigators propose here to evaluate the feasibility and safety of same-session MR-only simulation and treatment with SMART for spinal metastases. Although spine SBRT is a standard-of-care treatment modality, this expedited same-session MR-only simulation and treatment with SMART workflow is novel. Previously, delivery of spine SBRT has typically required several days from time of consultation to simulation and then 1-2 weeks from simulation to the initiation of treatment. On this proposed study, patients will not undergo computed tomography (CT) simulation and will instead have same-session MR-only simulation and treatment planning, on-table, using SMART. In this manner, patients would initiate treatment within just several days from the consult. Feasibility of the workflow will be defined as successful delivery of the first fraction of same-session MRI-only simulation and treatment with SMART on the first on-table attempt for at least 70% of patients. Patients will be treated in five fractions over 1-2 weeks. Although the long-term goal will be to achieve a significantly shortened time from consult to treatment as compared to traditional stereotactic body radiation therapy (SBRT) using simulation, the present study will be driven by short-term goals of workflow feasibility and safety.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • At least one disease site deemed to be suitable for treatment with spine SBRT as per radiation oncology evaluation.
  • Karnofsky Performance Status (KPS) ≥
  • Deemed medically fit for SBRT by treating physician
  • Diagnostic CT with images through the projected treatment area within six months prior to enrollment.
  • At least 18 years of age.
  • Ability to understand and willingness to sign an IRB approved written informed

排除标准

  • Past history of radiotherapy within the projected treatment field to be treated by MRI-guided SBRT
  • Medical contraindication to undergoing MR imaging.
  • Spine metastasis resulting in symptomatic spinal cord compression.
  • Any other condition that, in the opinion of the treating radiation oncologist, renders the patient unfit for SBRT.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.

结局指标

主要结局

Number of Participants to Receive Delivery of the First Fraction of Same-session MRI-only Simulation and Treatment With SMART on the First On-table Attempt

时间窗: First on-table attempt of first fraction of radiation (an average of 1 day)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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