Magnetic Resonance-Guided High Intensity Focused Ultrasound for Pain Management of Osteoid Osteoma and Benign Bone Tumors in Children and Young Adults
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
- Change in pain intensity scores from baseline related to the site treated target lesion.
研究概览
简要总结
The Philips Sonalleve HIFU system is expected to be efficacious in reducing pain scores in patients with painful osteoid osteoma and other benign bone tumors, and in reducing their pain medication usage. No serious adverse effects are expected to result from this treatment.
详细描述
The objective of this study is to determine if MR-guided high-intensity focused ultrasound (MR-HIFU) is safe and effective technique for alleviating the pain associated with osteoid osteoma and other benign bone tumors in paediatric patients and adults(up to age 40 yrs). This technique meant to be an alternative to the standard-of-care, radiofrequency and laser-based percutaneous ablation. Safety of the technique will be assessed through evaluating non-targeted heating using MRI based temperature mapping. and inspecting patients post treatment for skin burns or other signs of serious adverse events. Efficacy of the technique will be assessed by evaluating/recording patients observed pain, quality of life, and pain medication usage both before and up to 6 months following treatment.
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
- 5 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5-40 years.
- •Able to give informed consent and have parent or guardian give informed consent if applicable.
- •Weight <140 kg (requirement to fit safely on top of the HIFU table and inside the MRI).
- •Definitive radiographic & clinical presentation of osteoid osteoma or other benign tumor lesion(avoiding need for biopsy).
- •Pain specifically at the site of interest target lesion.
- •Pain score for target lesion >/= 4 (indicating at least moderate pain) or an age-appropriate pain scale.
- •Target lesion is uncomplicated (i.e. no fracture/spinal cord compression/cauda equina syndrome/soft tissue component).
- •MR-HIFU treatment date >/= 2 weeks from most recent surgical treatment of lesion.
排除标准
- •Unable to characterize pain specifically at the site of interest (target lesion).
- •Pregnant/nursing females.
- •Target lesion is complicated (i.e. presence of one of fracture/spinal cord compression/cauda equina syndrome/soft tissue component).
- •Target lesion < 1cm from neurovascular bundles/bowel/hollow viscera or regions of cartilage/ bone growth).
- •Target lesion located in skull, spine (excluding sacrum, which is allowed) or sternum.
- •Scar along proposed HIFU beam path.
- •Orthopaedic implant along proposed HIFU beam path or at site of target tissue.
- •Serious cardiovascular, neurological, renal or haematological chronic disease.
- •Active infection.
- •Contraindication to general anaesthetic or gadolinium MRI contrast agent.
- •Requirement for general anesthesia for non-HIFU related MRI's.
结局指标
主要结局
Change in pain intensity scores from baseline related to the site treated target lesion.
时间窗: 2, 7, 14, 30 and 90 days following treatment.
As measured on the pain diaries before and at day 2, 7, 14, 30 and 90 days after treatment.
次要结局
- Reduction in in pain medication usage (NSAIDS, Opioids).(2, 7, 14, 30 and 90 days following treatment.)
研究者
James Drake
Neurosurgeon
The Hospital for Sick Children