Multicenter Study of Magnetic Resonance-guided High Intensity Focused Ultrasound for Pain Palliation of Bone Metastases

April 3, 2017 updated by: Philips Healthcare

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

The purpose of this study is to evaluate the effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) device for treating painful bone metastases.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) is a non-invasive outpatient modality. In MR-HIFU, a specially designed ultrasound transducer is used to focus a beam of ultrasound energy into a small volume at a specific target site in the body. The focused beam is intended to produce therapeutic hyperthermia in the target field while only harmlessly warming the immediately surrounding tissue. Magnetic Resonance Imaging is used during the ultrasound treatment, both to focus the ultrasound beam on the target field and to perform real-time thermal mapping at and around the target.

The Philips Sonalleve MR-HIFU system is expected to be efficacious in reducing pain scores in patients with painful bone metastases and in reducing their pain medication usage.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Samsung Medical Center
  • Netherlands
      • Utrecht, Netherlands, 3508
        • University Medical Center Utrecht
  • United Kingdom
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Royal Marsden Hospital / Institute of Cancer Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women with age ≥ 18 years
  • Patient capable of giving informed consent and able to attend study visits
  • Weight < 140kg
  • Radiologic evidence of bone metastases from any solid tumor
  • Diagnosis of dominant painful bone metastasis (Numerical Representative Scale (NRS) pain score ≥4), either refractory to standard of care (including radiotherapy and optimal pain medication) or standard of care is contra-indicated or refused by patient.
  • Patient has been on stable pain medication for at least 1 week prior to HIFU treatment date
  • Pain is localized to the targeted area, or is likely to be referred pain arising from the targeted area
  • Patient has 1-3 painful lesions, and only the most painful lesion will be treated
  • Intended Target Volume accessible for MR-HIFU procedure
  • Target lesion maximum dimension ≤ 8cm
  • Intended target volume visible by non-contrast MRI
  • Distance between target and skin ≥ 1cm
  • Patient is able to communicate sensation during MR-HIFU treatment
  • MR-HIFU treatment date ≥ 4 weeks from last local treatment of the target lesion

Exclusion Criteria:

  • Planned treatment lesion is a primary bone tumor or due to lymphoma, multiple myeloma, or leukemia.
  • Communication barrier present
  • Patient enrolled in another clinical study related to bone metastases treatment or pain relief treatment
  • Unable to tolerate required stationary position during treatment
  • Need for surgical stabilization in case of (impending) fracture (lytic lesion in weight-bearing bone larger than 50% of bone diameter)
  • Pregnant woman
  • Pain related to target lesion is predominantly due to fracture or impending fracture
  • Pain related to target lesion is due to involvement of a neighboring major nerve by the metastatic tumor (cord or nerve compression)
  • Target < 3cm from bladder / bowel / nerve along the beam path and < 1cm in the plane orthogonal to the beam
  • Target in contact with hollow viscera
  • Target located in skull, joints, ribs (when HIFU beam overlapping with lung), spine (excluding sacrum which is allowed) or sternum
  • Scar along proposed HIFU beam path
  • Internal or external fixation device along the proposed HIFU beam path or at the target
  • MRI contraindicated (e.g. paramagnetic implants, pacemaker, claustrophobia)
  • MRI contrast agent contraindicated (e.g. previous anaphylaxis or Glomerular Filtration Rate (GFR) < 30 ml/min/1.73m2)
  • Sedation contraindicated
  • Previous surgery or minimally invasive treatment at targeted site
  • Clinically relevant medical history or abnormal physical findings that could interfere with the safety of the participant as judged by the treating physician or investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MR-HIFU treatment
Subjects undergo a MR-HIFU treatment for pain palliation of bone metastases on their most painful metastasis.
Device: MR-HIFU treatment for pain palliation of bone metastases
A treatment session with the Philips Sonalleve MR-HIFU device for bone pain palliation with high-intensity focused ultrasound.
Other Names:
  • Philips Sonalleve MR-HIFU Bone Pain Palliative Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain response to therapy
Time Frame: 30 days after treatment

Pain is measured using the Brief Pain Inventory (BPI) questionnaire. Patients are categorized into:

  • Complete response (CR): Pain score 0 without analgesic increase
  • Partial response (PR): Pain reduction of 2 or more without analgesic increase; or analgesic reduction of 25% without pain increase
  • Pain Progression (PP): Pain increase of 2 or more with stable analgesic use; or increase of 25% or more in analgesic use, with pain score stable or 1 point above baseline
  • No response corresponds to all other cases

Patients with PR or CR at 30 days are considered responders to therapy.
30 days after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of Adverse Events
Time Frame: within the first 90 days within treatment
Total number of complications and adverse events, including the number of unintended lesions that occur as a result of treatment with MR-HIFU.
within the first 90 days within treatment
Quality of Life (as measured by questionnaire)
Time Frame: at day 0 before treatment, and at 7, 14, 30, 60 and 90 days after treatment
Quality of Life will be measured at the given time points using a dedicated questionnaire for patients in palliative care: the European Organisation on Research and Treatment of Cancer (EORTC) C15-PAL questionnaire.
at day 0 before treatment, and at 7, 14, 30, 60 and 90 days after treatment
Subgroup analysis: pain response in radiation naïve patients
Time Frame: 30 days after treatment
Assessment of positive response on pain (as determined by the Primary Outcome Measure) will be documented separately for radiation naïve patients and radiation failure patients, and a comparison between the two sub-groups will be performed.
30 days after treatment
Temporal evolution of pain response during the first 30 days after treatment
Time Frame: during the first 30 days after treatment
Patients are given a diary to complete during the first 30 days after treatment, which documents their daily pain level on a 0-10 scale and their pain medication usage.
during the first 30 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Healthcare

Investigators

  • Principal Investigator: Maurice A van den Bosch, MD, PhD, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

April 24, 2012

First Submitted That Met QC Criteria

April 24, 2012

First Posted (Estimate)

April 26, 2012

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 906273

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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