Single Center Observational Study Using Spinal Laser Interstitial Thermal Therapy (sLITT) in the Treatment of Spine Metastases and Tumors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Local tumor control
研究概览
简要总结
The objective of this clinical study is to evaluate the efficacy and safety of spinal laser interstitial therapy in the treatment of metastatic spinal tumors. The investigators hypothesize that rates of local tumor control are comparable between conventional open surgical techniques and spinal laser interstitial therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histology confirmed spinal tumor involving the T2-T12 spine segments.
- •Indication for spine stereotactic radiosurgery or palliative intervention.
- •Normal neurologic exam at the time of presentation (Frankel grade E).
排除标准
- •Contraindication to MRI
- •ANY neurologic deficit
- •Tumor spanning more than 3 consecutive vertebral segments
- •Contraindication to general anesthesia
研究组 & 干预措施
Spinal Laser Interstitial Thermal Therapy (sLITT)
Patients will undergo surgery utilizing the Visualase Thermal Therapy System (Medtronic) device.
干预措施: ClearPoint Prism (Device)
结局指标
主要结局
Local tumor control
时间窗: Local control rate at 12 months
Any increase in the epidural spinal cord compression score (ESCC grade 1 (no compression) to 3 (spinal cord compression) compared to the initial post-procedure MRI will be considered local radiographic failure or evidence of tumor recurrence.
次要结局
- Evaluate neurologic function before and after sLITT.(3, 6, 9, and 12 months post-operatively)
研究者
Linton T. Evans
Director, Neuro-oncology, Principle Investigator, Assistant Professor
Dartmouth-Hitchcock Medical Center