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Clinical Trials/NCT01964677
NCT01964677
Completed
Not Applicable

Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study

Institute of Cancer Research, United Kingdom1 site in 1 country12 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Institute of Cancer Research, United Kingdom
Enrollment
12
Locations
1
Primary Endpoint
Pain response
Status
Completed
Last Updated
8 years ago

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

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
November 14, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Institute of Cancer Research, United Kingdom
Responsible Party
Principal Investigator
Principal Investigator

NdeSouza

Professor of Translational Imaging

Institute of Cancer Research, United Kingdom

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pain response

Time Frame: 30 days post-treatment

Study Sites (1)

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