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MR-HIFU for Bone Metastases

Primary Purpose

Cancer, Bone Metastases

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Cancer focused on measuring Magnetic Resonance Imaging (MRI), High Intensity Focused Ultrasound (HIFU)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

The Royal Marsden NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MR-HIFU of painful bone metastases

Arm Description

Outcomes

Primary Outcome Measures

Pain response

Secondary Outcome Measures

Full Information

NCT ID

NCT01964677

First Posted

October 15, 2013

Last Updated

August 18, 2017

Sponsor

Institute of Cancer Research, United Kingdom

Collaborators

Philips Medical Systems

1. Study Identification

Unique Protocol Identification Number

NCT01964677

Brief Title

MR-HIFU for Bone Metastases

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

November 14, 2016 (Actual)

Study Completion Date

November 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Institute of Cancer Research, United Kingdom

Collaborators

Philips Medical Systems

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Bone Metastases

Keywords

Magnetic Resonance Imaging (MRI), High Intensity Focused Ultrasound (HIFU)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MR-HIFU of painful bone metastases

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

Pain response

Time Frame

30 days post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nandita deSouza, Professor

Organizational Affiliation

ICR

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Royal Marsden NHS Foundation Trust

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

MR-HIFU for Bone Metastases

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