Bone Metastases, Cancer
Conditions
Keywords
Magnetic Resonance Imaging (MRI), High Intensity Focused Ultrasound (HIFU)
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
Interventions
Sponsors
Philips Medical Systems
Institute of Cancer Research, United Kingdom
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain response | 30 days post-treatment |
Countries
United Kingdom
Outcome results
None listed