3 Tesla Magnetic Resonance Guided High Intensity Focused Ultrasound (MR-HIFU) in the Treatment of Pain From Bone Metastases of Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pain response
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of the Philips Sonalleve 3 Tesla MR-HIFU device for treating painful bone metastases.
详细描述
This study is a single centre, single arm, non-randomized, non-blinded study. All eligible subjects will receive MR-HIFU therapy, and no blinding is necessary.
All patients will receive one session of MR-HIFU treatment with the Philips Sonalleve MR-HIFU device on the most painful of their bone metastases.
Will be enrolled in the study consecutive patients with painful skeletal metastases from any solid tumours. Patients with all severity grade of pain (mild, moderate and severe pain) will be included in the study.
At HIFU day (day 0) before treatment patient will be performed a bone lesion MRI and a functional brain MRI. The functional brain MRI is not clinical practice: it is not dangerous for the patient, it only involves a longer time of exam for the patient in the MRI site.
A Brief Pain Inventory, a EORTC-quality of life questionnaire-C15-paired-associate learning and information about pain medication recording will be collected always before treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Radiologic evidence of bone metastases (BM) from any solid tumors in patients with age ≥ 18 years
- •Patient capable of giving informed consent and able to attend study visits
- •All target lesion (s) at intended treatment site accessible for MR-HIFU Distance Skin-lesion (target) > 1 cm
- •Patient has 1-3 painful lesions, and only the most painful lesion will be treated
- •Weight < 140 Kg
- •Intended target volume visible by non-contrast MRI
- •Patient able to characterize pain at site of target lesion (s), before and after the procedure.
- •MR-HIFU treatment date ≥ 2 weeks from last local treatment of the target lesion
排除标准
- •Planned treatment lesion is a primary bone tumor 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 < 3cm from bladder / bowel / nerve along the beam path and < 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 glomerular filtration rate < 30 ml/min/1.73m2)
- •Sedation contraindicated
- •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.
研究组 & 干预措施
MR-HIFU Treatment
The Philips MR-HIFU Sonalleve System integrates a high intensity phased array focused ultrasound transducer with a 3 Tesla Magnetic Resonance (MR) imaging system and electromechanical transducer positioning system to deliver spatially and temporally controlled ultrasound energy and thermal heat to tissues non-invasively.
At HIFU day (day 0) before treatment patient will be performed a bone lesion MRI and a functional brain MRI.
During the treatment procedure, an intravenous catheter will deliver MR contrast media and medications (such as sedation and analgesics if required) within the MR room.
Following the MR-HIFU procedure, a set of MR images of the target region will be acquired with the use of a MR contrast agent, together with a functional brain MRI.
干预措施: MR-HIFU Treatment (Procedure)
MR-HIFU Treatment
The Philips MR-HIFU Sonalleve System integrates a high intensity phased array focused ultrasound transducer with a 3 Tesla Magnetic Resonance (MR) imaging system and electromechanical transducer positioning system to deliver spatially and temporally controlled ultrasound energy and thermal heat to tissues non-invasively.
At HIFU day (day 0) before treatment patient will be performed a bone lesion MRI and a functional brain MRI.
During the treatment procedure, an intravenous catheter will deliver MR contrast media and medications (such as sedation and analgesics if required) within the MR room.
Following the MR-HIFU procedure, a set of MR images of the target region will be acquired with the use of a MR contrast agent, together with a functional brain MRI.
干预措施: MR contrast media and medications (Drug)
MR-HIFU Treatment
The Philips MR-HIFU Sonalleve System integrates a high intensity phased array focused ultrasound transducer with a 3 Tesla Magnetic Resonance (MR) imaging system and electromechanical transducer positioning system to deliver spatially and temporally controlled ultrasound energy and thermal heat to tissues non-invasively.
At HIFU day (day 0) before treatment patient will be performed a bone lesion MRI and a functional brain MRI.
During the treatment procedure, an intravenous catheter will deliver MR contrast media and medications (such as sedation and analgesics if required) within the MR room.
Following the MR-HIFU procedure, a set of MR images of the target region will be acquired with the use of a MR contrast agent, together with a functional brain MRI.
干预措施: MR images (Procedure)
结局指标
主要结局
Pain response
时间窗: up to 90 days after study treatment
multidimensional score: the Brief Pain Inventory
次要结局
- Side effects(up to 90 days after study treatment)
- reduction/increase of tumor markers(at day 14, 30 and 90 after study treatment)
- Time to pain palliation(up to 30 days after study treatment)
- Time to pain progression(up to 30 days after study treatment)
- Duration of pain palliation(up to 30 days after study treatment)
- Recording of pain medication(24 hours before study treament)
- Quality of Life on the EORTC-QLQ-C15-PAL scale12(0, 3, 7, 14 and 30 days following treatment, and additionally at 60 and at 90 days if the subject has not been referred to an alternative local treatment)
- Local Tumor Control(at 30 days and 90 days after study treatment)
- identification of the brain regions involved in oncological pain(up to 90 days after study treatment)