Health Condition 1: null- Painful Bone Metastases
Conditions
Interventions
Intervention1: Sonalleve MR-HIFU for Palliation of Painful Bone Metastases: Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) is a non-invasive outpatient modality being investigat
Sponsors
Philips Medical Systems MR Finland
Eligibility
Inclusion criteria
Inclusion criteria: Men and women with age 18 years or older Patient capable of giving informed consent and able to attend study visits Weight less than 140kg Radiologic evidence of bone metastases from any solid tumor Diagnosis of dominant painful bone metastasis (NRS 4 or more), 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 less or equal 8cm Intended target volume visible by non-contrast MR imaging Distance between target and skin greater or equal 1cm Patient is able to communicate sensation during MR-HIFU treatment MR-HIFU treatment date greater or equal 4 weeks from last local treatment of the target lesion MR-HIFU treatment date greater or equal 4 weeks from participation in another clinical trial
Exclusion criteria
Exclusion criteria: Patients with the following Exclusion Criteria cannot be enrolled in the study: Planned treatment lesion is a primary bone tumor or due to lymphoma, multiple myeloma, or leukemia. Communication barrier present 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 percent 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 less than 3cm from bladder / bowel / nerve along the beam path and less than 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 GFR less than 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Response to treatment on the Numerical Representative Scale (NRS 0-10)Timepoint: measured 30 days post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Complications / Safety Events, including Unintended Lesions on MRITimepoint: throughout 90 day follow-up period;Exploratory Imaging Endpoint: change in lesion characteristics on X-ray and MRITimepoint: 30, 60 and 90 days post-treatment;Quality of Life on the EORTC-QLQ-C15-PAL scaleTimepoint: 0, 7, 14, 30, 60 and 90 days post treatment;Subgroup analysis: pain response in radiation naive patientsTimepoint: measured 30 days post-treatment;Temporal evolution of pain responseTimepoint: during the first 30 days after treatment | — |
Countries
India, Netherlands, United Kingdom
Contacts
Public ContactDr Avinash Auti
SRL Diagnostics - Jankharia Imaging
Outcome results
None listed