Overview

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 December 2016
Trial size 12 participants
Trial identifier NCT01964677, 12/LO/0424 CCR3772

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
magnetic resonance image-guided high intensity focused ultrasound (mr-hifu)

Primary Outcomes

Measure
Pain response
time frame: 30 days post-treatment

Eligibility Criteria

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

Additional Information

Official title Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study
Principal investigator Nandita deSouza, Professor
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Institute of Cancer Research, United Kingdom.