MR-HIFU for Bone Metastases
This trial is active, not recruiting.
|Conditions||cancer, bone metastases|
|Treatment||magnetic resonance image-guided high intensity focused ultrasound (mr-hifu)|
|Sponsor||Institute of Cancer Research, United Kingdom|
|Collaborator||Philips Medical Systems|
|Start date||January 2014|
|End date||April 2017|
|Trial size||12 participants|
|Trial identifier||NCT01964677, 12/LO/0424 CCR3772|
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
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
time frame: 30 days post-treatment
Male or female participants at least 18 years old.
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
|Official title||Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study|
|Principal investigator||Nandita deSouza, Professor|
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