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