MR-HIFU for Bone Metastases

Institute of Cancer Research, United Kingdom

Status: Completed

Conditions: Cancer; Bone Metastases

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01964677

12/LO/0424 CCR3772

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

MR-HIFU of painful bone metastases

Experimental group

Treatment:

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