Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study.
- Conditions
- bone disseminations.Bone metastases1000594210027476
- Registration Number
- NL-OMON39361
- Lead Sponsor
- Philips Medical Systems, MR Finland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
Men and women with age * 18 years.
Capable of giving informed consent and able to attend study visits.
Weight < 140 kg.
Radiologic evidence of bone metastases from any solid tumor.
Diagnosis of dominant painful bone metastasis (NRS * 4), either refractory to standard of care (including radiotherapy and optimal pain medication) or standard of care is refused by patient or contra-indicated.
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 * 8 cm.
Intended target volume visible by non-contrast MR imaging.
Distance between target and skin * 1 cm.
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 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 < 3 cm from bladder / bowel / nerve along the beam path and < 1 cm 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 < 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is the pain response (dichotomous outcome) 30 days<br /><br>after treatment. Pain response is determined by comparing pain score (NRS) and<br /><br>pain medication at 30 days after treatment with baseline values in the same<br /><br>patient. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Incidence of adverse events.<br /><br>Quality-of-life.<br /><br>Time-related aspects of pain response.<br /><br>Changes in size/enhancement pattern on x-ray and MRI.</p><br>