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

This is an interventional treatment trial for Bone Metastasis Read More

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