NCT01640847撤回2 期
Phase II Trial of Phillips MRI-Guided High Intensity Focused Ultrasound (Sonalleve) and Lyso-thermosensitive Liposomal Doxorubicin (ThermoDox) for Palliation of Painful Bone Metastases
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Imunon
- 主要终点
- Rate of complete pain response
研究概览
简要总结
This study will evaluate treatment with High Intensity Focused Ultrasound (HIFU)in combination with ThermoDox (liposomal doxorubicin) is safe and effective in reducing pain for patients with painful bone metastases.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of breast carcinoma, non-small cell lung cancer, small cell lung cancer, or adenocarcinoma of the prostate
- •Bone metastases index lesion in the ribs, clavicle, scapula, upper extremities, pelvis, or posterior aspects of the lumbar vertebra L3-L5 or sacral S1-S
- •Patients will have failed at least one prior attempt or will not be eligible for external beam radiation therapy (EBRT)
排除标准
- •Greater than 450 mg/m2 of prior free doxorubicin and/or non-heat activated liposomal doxorubicin
- •LVEF < 50%
- •Significant Cardiac History
- •Brain Metastases
- •Contraindication for MR imaging (as incompatible implanted metallic device, weight >250 lbs etc) or known intolerance or allergy to MRI contrast agents.
研究组 & 干预措施
Arm NRT: HIFU plus ThermoDox
Experimental
Subjects have no yet received any radiation to the index lesion.
干预措施: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox (Drug)
Arm RT: HIFU plus ThermoDox
Experimental
Index lesion has been treated with EBRT and is currently painful, but these subjects have already received their maximum cumulative EBRT dose.
干预措施: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox (Drug)
结局指标
主要结局
Rate of complete pain response
时间窗: 12 months
次要结局
- Adverse Events(3 months)
研究者
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