Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Pain response
Study Overview
Brief Summary
The aim of this study is to evaluate effectiveness of the Philips Sonalleve MR-HIFU device for the palliation of pain in patients with bone metastases.
Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) uses ultrasound to palliate pain caused by bone metastases. The main palliative mechanism of the method is due to local bone denervation, caused by the heat denaturation of the periosteum layer in the treated area. The importance of this therapy is that it offers a non-invasive, focal therapy, avoiding side-effects to surrounding normal tissue that occur with radiation therapy or the need for needle insertion as with radio-frequency(RF)ablation.
The study hypothesis is that MR-HIFU will be effective in treating the pain associated with bone metastases
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •radiologic evidence of bone metastases from any solid tumour
- •diagnosis of dominant painful bone metastasis
- •target lesion less than 8cm
Exclusion Criteria
- •primary bone tumours rather than metastases
- •Inability to tolerate stationary position during treatment
- •pregnancy
- •MRI incompatible metal implants
Arms & Interventions
MR-HIFU of painful bone metastases
Intervention: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU) (Device)
Outcomes
Primary Outcomes
Pain response
Time Frame: 30 days post-treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
NdeSouza
Professor of Translational Imaging
Institute of Cancer Research, United Kingdom