Multicenter Study of Magnetic Resonance-guided High Intensity Focused Ultrasound for Pain Palliation of Bone Metastases
|Bone Metastasis||Device: MR-HIFU treatment for pain palliation of bone metastases|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Magnetic Resonance-guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study|
- Pain response to therapy [ Time Frame: 30 days after treatment ]
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.
- Total number of Adverse Events [ Time Frame: within the first 90 days within treatment ]Total number of complications and adverse events, including the number of unintended lesions that occur as a result of treatment with MR-HIFU.
- Quality of Life (as measured by questionnaire) [ Time Frame: at day 0 before treatment, and at 7, 14, 30, 60 and 90 days after treatment ]Quality of Life will be measured at the given time points using a dedicated questionnaire for patients in palliative care: the European Organisation on Research and Treatment of Cancer (EORTC) C15-PAL questionnaire.
- Subgroup analysis: pain response in radiation naïve patients [ Time Frame: 30 days after treatment ]Assessment of positive response on pain (as determined by the Primary Outcome Measure) will be documented separately for radiation naïve patients and radiation failure patients, and a comparison between the two sub-groups will be performed.
- Temporal evolution of pain response during the first 30 days after treatment [ Time Frame: during the first 30 days after treatment ]Patients are given a diary to complete during the first 30 days after treatment, which documents their daily pain level on a 0-10 scale and their pain medication usage.
|Study Start Date:||September 2012|
|Study Completion Date:||November 2016|
|Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Experimental: MR-HIFU treatment
Subjects undergo a MR-HIFU treatment for pain palliation of bone metastases on their most painful metastasis.
Device: MR-HIFU treatment for pain palliation of bone metastases
A treatment session with the Philips Sonalleve MR-HIFU device for bone pain palliation with high-intensity focused ultrasound.
Other Name: Philips Sonalleve MR-HIFU Bone Pain Palliative Therapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586273
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of|
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3508|
|Royal Marsden Hospital / Institute of Cancer Research|
|Sutton, Surrey, United Kingdom, SM2 5PT|
|Principal Investigator:||Maurice A van den Bosch, MD, PhD||UMC Utrecht|