NCT01964677

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2016

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

2.9 years

First QC Date

October 15, 2013

Last Update Submit

August 18, 2017

Conditions

CancerBone Metastases

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Pain response

    30 days post-treatment

Study Arms (1)

MR-HIFU of painful bone metastases

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

Interventions

Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)DEVICE
MR-HIFU of painful bone metastases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • radiologic evidence of bone metastases from any solid tumour
  • diagnosis of dominant painful bone metastasis
  • target lesion less than 8cm

You may not qualify if:

  • primary bone tumours rather than metastases
  • Inability to tolerate stationary position during treatment
  • pregnancy
  • MRI incompatible metal implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Nandita deSouza, Professor

    ICR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Translational Imaging

Study Record Dates

First Submitted

October 15, 2013

First Posted

October 17, 2013

Study Start

January 1, 2014

Primary Completion

November 14, 2016

Study Completion

November 14, 2016

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

GB(1)