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

18 Years
Open (Enrolling)
Bone Metastasis

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Trial Information

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

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.

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 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

- MR-HIFU treatment date ≥ 4 weeks from participation in another clinical trial

Exclusion Criteria:

- Planned treatment lesion is a primary bone tumor or due to lymphoma, multiple
myeloma, or leukemia.

- Communication barrier present

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pain response to therapy

Outcome Description:

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.

Outcome Time Frame:

30 days after treatment

Safety Issue:


Principal Investigator

Maurice A van den Bosch, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMC Utrecht


Netherlands: Medical Ethics Review Committee (METC)

Study ID:




Start Date:

September 2012

Completion Date:

September 2013

Related Keywords:

  • Bone Metastasis
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Bone Neoplasms
  • Bone Marrow Diseases