A Study to Determine Correlation of MR Thermal Imaging to Actual Size of Ablation During Laser Therapy of Metastases to Bone
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Correlation of Maximal Dimensions of 60-degree Celsius Isotherm + Ablation Zone Dimensions as determined by MRI
研究概览
简要总结
The goal of this clinical research study is to learn how well magnetic resonance thermal imaging (MRTI) can check the amount of tumor being destroyed using a therapy called laser ablation (a procedure that uses lasers to create heat that is designed to destroy cancer cells).
详细描述
Laser ablation is designed to destroy tumor tissue with the use of fiber optics that are placed directly into the tumor to deliver laser light energy into the tissue.
In this study, tumor destruction will be checked using MRTI. MRTI is very similar to other MRI techniques, but instead of providing imaging data, MRTI will provide temperature data for cancerous areas in the body during the laser ablation process. If tumor temperature can be measured more accurately, the laser ablation process may be safer.
Laser Ablation and the MRTI Scan:
If you are found to be eligible to take part in this study, on the day you have laser ablation, you will have an intravenous (IV) line placed. You will receive sedation or general anaesthesia (drugs to make you sleep) through a needle in your vein over 1-3 hours to lessen any pain you may have during the procedure. This process will be explained to you.
After receiving the anaesthesia, the following tests and procedures will be performed:
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
- 否
入选标准
- •Patients with tumor metastases to the skeleton who are referred to interventional radiology for percutaneous ablation
- •Surgery is not a viable or desirable alternative therapy at the time of enrollment
- •Radiation therapy has failed or not indicated or can be safely postponed
- •Symptomatic or asymptomatic tumor size less than or equal to 3 cm in its largest diameter.
- •Performance status is Eastern Cooperative Oncology Group 2 or better in adults
- •Patient is able to undergo MRI
- •Patients at least 18 years of age
排除标准
- •Patients with uncorrectable coagulopathy
- •Patients with pacemaker or defibrillator
- •Patients with metallic prosthesis at the site of the intended ablation
- •Patients with spinal cord compression or epidural tumor extension
- •Patients with vertebral body metastases exhibiting posterior wall destruction
- •Patients with any soft tissue extension of a vertebral tumor
- •Patients with any metastasis that is extrinsically located in vertebra or any long bones of the extremities compromising the cortex
- •Patients with tumors having direct extension or involvement of a joint capsule or a major nerve
- •Patients with Neutropenia (ANC less then 1000) or known active infection
- •Patients unable to undergo conscious sedation
- •Children under 18 years of age will be excluded from this study
结局指标
主要结局
Correlation of Maximal Dimensions of 60-degree Celsius Isotherm + Ablation Zone Dimensions as determined by MRI
时间窗: 2 Years
Magnetic resonance thermal imaging (MRTI) data to determine the correlation between observed temperatures determined from MRTI and the actual size of ablation as determined by post-ablation contrast-enhanced magnetic resonance imaging (MRI) during Laser Induced Thermal Therapy (LITT) of soft tissue metastases in bone.
次要结局
未报告次要终点