临床试验/NCT01640847

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

Imunon0 个研究点开始时间: 2012年7月最近更新: 2017年2月7日

适应症

干预措施

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

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

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

发起方

Imunon

申办方类型

Industry

责任方

Sponsor

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