Primary Pain Palliation and Local Tumor Control in Bone Metastases Treated With Magnetic Resonance-guided Focused Ultrasound
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- To evaluate the safety and efficacy of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for the primary treatment of painful bone metastases
研究概览
简要总结
Magnetic Resonance guided Focused Ultrasound (MRgFUS) has demonstrated to be effective for pain control through thermally-induced cell death and periosteal denervation caused by cortical heating relative to acoustic energy absorption. There is also evidence that a high intensity focused ultrasound beam can penetrate through the cortical bone to the medullary space, producing thermal necrosis of cancer tissue. However, little is known about the potential effects of MRgFUS as first line therapeutic modality for pain palliation in skeletal metastases.
Our hypothesis sought to assess the clinical performance of MRgFUS primary treatment of painful bone metastases and determine the potential of this technique for local tumor control.
详细描述
Unlike previous studies, in which patients were enrolled for MRgFUS treatment because of the failure of other therapies, our study will be conducted in patients not previously treated with EBRT to the targeted lesion.
This is an important new feature, especially given the advantages of MRgFUS, such as lack of ionizing radiation, the ability to conduct treatment on an outpatient basis and the possibility to repeat the treatment as necessary.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the presence of a known primary cancer and bone metastases confirmed by two or more imaging modalities;
- •exhaustion or refusal of all other pain palliation methods including EBRT;
- •confirmation of MRgFUS treatment feasibility at a preliminary MR planning examination (presence of an adequate acoustic window between the transducer, skin and target lesion and absence of bowel loops across the planned ultrasound path)
排除标准
- •general contraindication to MR imaging (including pacemaker, ferromagnetic devices or implants)
- •general contraindication to gadolinium-based contrast agents (intolerance and/or clinically proven chronic renal failure)
- •general contraindication to general/epidural anesthesia or deep sedation
研究组 & 干预措施
MRgFUS
High intensity focused ultrasound energy, delivered under the guidance of the MR images (MgFUS) allows for a predefined amount of energy to be delivered in the desired target (Metastasis). Bone readily absorbs focused ultrasound energy resulting in a thermo-related neurolysis of the periostium with consequent pain palliation. The amount of energy delivered can be modulated with the objective to penetrate cortical space and obtain necrosis of the metastasis thus preventing local recurrence.
干预措施: MRgFUS (Procedure)
结局指标
主要结局
To evaluate the safety and efficacy of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for the primary treatment of painful bone metastases
时间窗: 6 months
Patients will be monitored for major or minor adverse events
次要结局
- To correlate the treatment response to extent of tumor necrosis as determined by follow-up imaging(6 months)
研究者
Alessandro Napoli
MD, PhD
University of Roma La Sapienza