MR-HIFU for Bone Metastases

NCT ID: NCT01964677

Last Updated: 2017-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-11-14

Brief Summary

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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

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Conditions

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Cancer Bone Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MR-HIFU of painful bone metastases

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Interventions

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philips Medical Systems

INDUSTRY

Sponsor Role collaborator

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role lead

Responsible Party

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NdeSouza

Professor of Translational Imaging

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nandita deSouza, Professor

Role: PRINCIPAL_INVESTIGATOR

ICR

Locations

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The Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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12/LO/0424 CCR3772

Identifier Type: -

Identifier Source: org_study_id

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