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MR-HIFU for Bone Metastases

Not Applicable
Completed
Conditions
Bone Metastases
Cancer
Interventions
Device: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)
Registration Number
NCT01964677
Lead Sponsor
Institute of Cancer Research, United Kingdom
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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
MR-HIFU of painful bone metastasesMagnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)-
Primary Outcome Measures
NameTimeMethod
Pain response30 days post-treatment
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The Royal Marsden NHS Foundation Trust

🇬🇧

Sutton, Surrey, United Kingdom

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