A Pilot Study to Evaluate Safety of Intraoperative MRI-Based Image Guidance for Laser Ablation of Epidural Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Safety determined by 0% frequency of intraoperative and perioperative adverse events
研究概览
简要总结
The goal of this clinical research study is to learn about the safety and accuracy of using MRI as a guidance system during laser ablation surgery of tumors that have spread to the spine.
详细描述
Study Visits:
If you agree to take part in this study, before your surgery:
- You will have a physical exam.
- You will have a neurological exam (tests to check the functioning of your nerves, including tests of your balance and reflexes).
- You will complete questionnaires about pain and other symptoms that should take about 10-15 minutes.
- You will sign a separate consent for your spinal surgery that explains the risks.
During the Surgery:
You will be positioned lying face down on your stomach during surgery. While you are under anesthesia, an MRI will be used to take images of your spine. This is an intraoperative MRI, meaning that it is performed in a special magnet located inside a specifically designed operating room. These images will be loaded into a computer navigation program and will be used to help the doctor perform surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Age =/> 18 years old.
- •Must have epidural metastasis to be treated with MRI-guided laser ablation.
- •Vertebral body site to be treated is located from C3 to L
- •Signed informed consent.
排除标准
- •Requires open spinal procedure or a percutaneous procedure without the use of image guidance.
- •Unable to tolerate general anesthesia and prone position.
- •Unable to undergo MRI of the spine.
- •Pregnant female.
研究组 & 干预措施
MRI-Based Image Guidance
MRI images of the spine taken of anesthetized participant in the operative prone position. These images are exported into a computer navigation program, and used to help the doctor perform surgery.
Pain and symptom questionnaires completed at baseline and at follow up.
干预措施: Magnetic Resonance Imaging (MRI) (Procedure)
MRI-Based Image Guidance
MRI images of the spine taken of anesthetized participant in the operative prone position. These images are exported into a computer navigation program, and used to help the doctor perform surgery.
Pain and symptom questionnaires completed at baseline and at follow up.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Safety determined by 0% frequency of intraoperative and perioperative adverse events
时间窗: 3 weeks
Safety of Intraoperative MRI-Based Image Guidance to Perform Laser Ablation of Epidural Metastasis
次要结局
- Accuracy of MRI-Based Image Guidance to Perform Laser Ablation of Epidural Metastasis(1 day)