JPRN-UMIN000030296已完成未知
A clinical study of Safety and Practicality of Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) treatment for painful bone metastases - A study of MRgFUS treatment for painful bone metastases
Teikyo University School of Medicine0 个研究点目标入组 10 人开始时间: 2017年12月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Patients with uncontrolled pain lesion except for targeted tumor. 2) More than 4 painful lesions. 3) Patients with NRS (0-10 scale) pain score <4 irrespective of medication. 4) No radiation therapy or chemotherapy in the past two weeks. 5) Patients with unstability of targeted tumor: -Pathological fracture -Need surgical stabilization in impending fracture. -Patients with surgical stabilization with metallic hard ware. 6) Patients on dialysis. 7) Patients with unstable cardiac status which interfere with daily life. -Unstable angina pectoris on medication. -Patients developed myocardial infarction within six months of protocol entry. -Congestive heart failure requiring medication (other than siuretic). -Any patients disqualified by a study physician because of their cardiac status. 8) Patients with severe hypertension (diastolic BP > 100 on medication). 9) Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight > 113kilograms) and claustrophobia. 10) Known hypersensitivity to the MRI contrast agent (e.g. Magnevist etc.) including advanced kidney disease. 11) Karnofsky Performance Status < 60. 12) Severe cerebrovascular disease (multiple CVA or CVA within 6 months). 13) Individuals who are not able to tolerate prolonged stationary position during treatment (approximately 2 hrs). 14) Patients whose targeted tumor is less than 10-mm from nurve bundle, intestine or bladder. 15) Patients who are participating or have participated in another clinical trial in last 30 days. 16) Patients unable to communicate with the investigator and staff. 17) Pain source unidentifiable. 18) Patients who are pregnant or lactating. 19) Conspicuous prolong of coagulation time (limit to INR>1.5). 20) Any patients disqualified by a study physician or any other reason.
研究者
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