The purpose of this study is to evaluate the effectiveness of the Philips Sonalleve Magnetic
Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) device for treating
painful bone metastases.
Device: MR-HIFU treatment for pain palliation of bone metastases
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Locations near you
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Full eligibility criteria for NCT01586273
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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)
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
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