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NCT01964677 Clinical Trial

MR-HIFU for Bone Metastases

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01964677
Other study ID # 12/LO/0424 CCR3772
Secondary ID
Status Completed
Phase N/A
First received October 15, 2013
Last updated August 18, 2017
Start date January 2014
Est. completion date November 14, 2016

Study information
Verified date August 2017
Source Institute of Cancer Research, United Kingdom
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date November 14, 2016
Est. primary completion date November 14, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)

Locations
Country Name City State
United Kingdom The Royal Marsden NHS Foundation Trust Sutton Surrey

Sponsors (2)
Lead Sponsor Collaborator
Institute of Cancer Research, United Kingdom Philips Medical Systems

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain response 30 days post-treatment
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