CTRI/2013/04/003572招募中4 期
Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study
Philips Medical Systems MR Finland0 个研究点目标入组 62 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 62
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
入选标准
- •Men and women with age 18 years or older
- •Patient capable of giving informed consent and able to attend study visits
- •Weight less than 140kg
- •Radiologic evidence of bone metastases from any solid tumor
- •Diagnosis of dominant painful bone metastasis (NRS 4 or more), either refractory to standard of care (including radiotherapy and optimal pain medication) or standard of care is contra-indicated or refused by patient.
- •Patient has been on stable pain medication for at least 1 week prior to HIFU treatment date
- •Pain is localized to the targeted area, or is likely to be referred pain arising from the targeted area
- •Patient has 1-3 painful lesions, and only the most painful lesion will be treated
- •Intended Target Volume accessible for MR-HIFU procedure
- •Target lesion maximum dimension less or equal 8cm
- •Intended target volume visible by non-contrast MR imaging
- •Distance between target and skin greater or equal 1cm
- •Patient is able to communicate sensation during MR-HIFU treatment
- •MR-HIFU treatment date greater or equal 4 weeks from last local treatment of the target lesion
- •MR-HIFU treatment date greater or equal 4 weeks from participation in another clinical trial
排除标准
- •Patients with the following Exclusion Criteria cannot be enrolled in the study:
- •Planned treatment lesion is a primary bone tumor or due to lymphoma, multiple myeloma, or leukemia.
- •Communication barrier present
- •Unable to tolerate required stationary position during treatment
- •Need for surgical stabilization in case of (impending) fracture (lytic lesion in weight-bearing bone larger than 50 percent of bone diameter)
- •Pregnant woman
- •Pain related to target lesion is predominantly due to fracture or impending fracture
- •Pain related to target lesion is due to involvement of a neighboring major nerve by the metastatic tumor (cord or nerve compression)
- •Target less than 3cm from bladder / bowel / nerve along the beam path and less than 1cm in the plane orthogonal to the beam
- •Target in contact with hollow viscera
- •Target located in skull, joints, ribs (when HIFU beam overlapping with lung), spine (excluding sacrum which is allowed) or sternum
- •Scar along proposed HIFU beam path
- •Internal or external fixation device along the proposed HIFU beam path or at the target
- •MRI contraindicated (e.g. paramagnetic implants, pacemaker, claustrophobia)
- •MRI contrast agent contraindicated (e.g. previous anaphylaxis or GFR less than 30 ml/min/1.73m2)
- •Sedation contraindicated
- •Previous surgery or minimally invasive treatment at targeted site
- •Clinically relevant medical history or abnormal physical findings that could interfere with the safety of the participant as judged by the treating physician or investigator
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