Feasibility of Combined Focused Ultrasound and Radiotherapy Treatment in Patients With Painful Bone Metastasis

Inclusion Criteria: * Men and women with age ≥ 18 years * Patient capable of giving informed consent and able to attend study visits * Uncomplicated painful bone metastases * Weight \<140kg and able to fit in the MRI gantry * Radiologic evidence of bone metastases from any solid tumor * Pain is localized to the targeted area, or is likely to be referred pain arising from the targeted area * Pain related to the target lesion is refractory to less invasive treatments for pain relief * Multiple metastatic lesions, with one predominantly painful lesion (\>=2 points higher pain score than other lesions). The lesion should be clearly distinguishable from other painful lesions. * Device accessible tumors: extremities (excluding joints), pelvis, shoulders, posterior vertebral spine below L5, in selected cases ribs and sternum * Target lesion maximum dimension ≤ 8cm * Intended target volume visible by non-contrast MR imaging * Distance between target and skin ≥ 1cm * Numeric Rating Scale (NRS) score \>= 4 or equivalent * Life expectancy \>3 months Exclusion Criteria: * Planned treatment lesion is a primary bone tumor or due to lymphoma, multiple myeloma, 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 despite adequate pain medication * Need for surgery * 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 in most cases sternum * 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 \< 20 ml/min/1.73m2) * Sedation contraindicated * Previous surgery or minimally invasive treatment at targeted site within the last three months * 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 * Karnofsky performance score (KPS) \< 60% * Oligometastatic disease planned for curative treatment * Indication for stereotactic radiotherapy (e.g. patients with radioresistant histology such as renal cell, melanoma, sarcoma metastases) * History of photodermatoses (of the skin overlying the target area) * Need for remineralisation