Clinical Trial Testing Ultrasound System for Painful Bone Mets

Cancer that has spread to the bone can be excruciatingly painful.  Currently radiation treatment or opiate drugs are used to manage pain, but these are not always successful.

A system that combines magnetic resonance imaging (MRI) with ultrasound treatment to destroy bone tumors and treat pain is being evaluated in a randomized Phase III clinical trial at a number of centers in the United States, Canada, and Israel.

BM004: A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain in Patients Who are not Candidates for Radiation Therapy is sponsored by InSightec Ltd.

ExAblate 2000, magnetic resonance guided focused ultrasound (MRgFUS) was developed by Insightec and has been used to treat uterine fibroids since 2004.  Magnetic resonance imaging focuses high-intensity ultrasound waves on tumor tissue to destroy it and relieve pain.  Doctors can measure and adjust increasing temperature in tumors being treated during therapy.

Patients eligible for the trial include those

  • with 1 to 3 painful metastases to their bones.
  • whose pain has not improved despite radiotherapy or who are unable to use radiotherapy.
  • with pain scores at least 4 or higher.
  • whose bone tumors are less than 8 centimeters.
  • who are able to communicate sensations during the ExAblate treatment
  • have tumors clearly visible on MRI and accessible to MRgUS

Ineligible patients

  • have more than 3 painful bone tumors
  • are unable to remain in a stationary position for up to 2 hours
  • have metal stabilization of bones at the treatment site
  • need surgical or other treatment to prevent fractures at the treatment site
  • have medical conditions that don’t allow MRgUS treatment

The trial will be randomized, with some patients receiving a sham treatment.   The primary outcome of the trial will be a change in pain scores over the three months after treatment.  In addition, adverse events from use of the ExAblate device and reduction in the need for pain medicine will be measured.

To find a contact at a site where the trial is being offered go to the bottom of the study information page at ClinicalTrials.Gov.  The clinical trials identifier is NCT00656305.

Insightec Ltd. has additional information about ExAblate and the trial.

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