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OpenTrials
Completed

NCT Number: NCT01964677

MR-HIFU for Bone Metastases

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

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Key information

Conditions

Cancer Bone Metastases Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Primary outcomes

  1. Pain response

    Time frame: 30 days post-treatment

Sponsors and collaborators

Lead sponsor

Institute of Cancer Research, United Kingdom

Other

Collaborators

  • Philips Medical Systems

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 17, 2013
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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