Multicenter Study of Magnetic Resonance-guided High Intensity Focused Ultrasound for Pain Palliation of Bone Metastases

Inclusion Criteria: * Men and women with age ≥ 18 years * Patient capable of giving informed consent and able to attend study visits * Weight \< 140kg * Radiologic evidence of bone metastases from any solid tumor * Diagnosis of dominant painful bone metastasis (Numerical Representative Scale (NRS) pain score ≥4), 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 ≤ 8cm * Intended target volume visible by non-contrast MRI * Distance between target and skin ≥ 1cm * Patient is able to communicate sensation during MR-HIFU treatment * MR-HIFU treatment date ≥ 4 weeks from last local treatment of the target lesion 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 * 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 (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