A study to test the efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound in reducing pain associated with painful bone cancer
- Conditions
- Health Condition 1: null- Painful Bone Metastases
- Registration Number
- CTRI/2013/04/003572
- Lead Sponsor
- Philips Medical Systems MR Finland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 62
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain Response to treatment on the Numerical Representative Scale (NRS 0-10)Timepoint: measured 30 days post treatment
- Secondary Outcome Measures
Name Time Method 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