NL-OMON39361已完成不适用
Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study. - MR-HIFU for Bone Metastases - Multicenter.
Philips Medical Systems, MR Finland0 个研究点目标入组 14 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Men and women with age * 18 years.
- •Capable of giving informed consent and able to attend study visits.
- •Weight < 140 kg.
- •Radiologic evidence of bone metastases from any solid tumor.
- •Diagnosis of dominant painful bone metastasis (NRS * 4), either refractory to standard of care (including radiotherapy and optimal pain medication) or standard of care is refused by patient or contra-indicated.
- •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 * 8 cm.
- •Intended target volume visible by non-contrast MR imaging.
- •Distance between target and skin * 1 cm.
- •Patient is able to communicate sensation during MR-HIFU treatment.
- •MR-HIFU treatment date * 4 weeks from last local treatment of the target lesion.
排除标准
- •Planned treatment lesion is a primary bone tumor or due to lymphoma or leukemia.
- •Communication barrier present.
- •Patient enrolled in another clinical study related to bone metastases treatment or pain relief treatment.
- •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% 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 < 3 cm from bladder / bowel / nerve along the beam path and < 1 cm 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 < 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.
研究者
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