Bone metastases metastatic bone disease
Conditions
Interventions
Following standard EBRT (single or multiple fraction), patients will receive
one MR-HIFU treatment with the Profound Sonalleve MR-HIFU device on the most
painful of their bone metastases. Patients w
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Men and women with age * 18 years; - Patient capable of giving informed consent and able to attend study visits; - Uncomplicated painful bone metastases; - Weight 3 months.
Exclusion criteria
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 despite adequate pain medication; - Need for surgery; - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome of this study is feasibility of the procedure, in terms of plannability as well as patient-tolerability of the combined treatment within a short time frame (3 hours - 4 days interval). | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition, pain relief and safety of the combined procedure will be monitored. | — |
Countries
Netherlands
Outcome results
None listed