Magnetic Resonance-guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study
Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) is a
non-invasive outpatient modality. In MR-HIFU, a specially designed ultrasound transducer is
used to focus a beam of ultrasound energy into a small volume at a specific target site in
the body. The focused beam is intended to produce therapeutic hyperthermia in the target
field while only harmlessly warming the immediately surrounding tissue. Magnetic Resonance
Imaging is used during the ultrasound treatment, both to focus the ultrasound beam on the
target field and to perform real-time thermal mapping at and around the target.
The Philips Sonalleve MR-HIFU system is expected to be efficacious in reducing pain scores
in patients with painful bone metastases and in reducing their pain medication usage.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pain response to therapy
Pain is measured using the Brief Pain Inventory (BPI) questionnaire. Patients are categorized into: Complete response (CR): Pain score 0 without analgesic increase Partial response (PR): Pain reduction of 2 or more without analgesic increase; or analgesic reduction of 25% without pain increase Pain Progression (PP): Pain increase of 2 or more with stable analgesic use; or increase of 25% or more in analgesic use, with pain score stable or 1 point above baseline No response corresponds to all other cases Patients with PR or CR at 30 days are considered responders to therapy.
30 days after treatment
Maurice A van den Bosch, MD, PhD
Netherlands: Medical Ethics Review Committee (METC)