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

Philips

Status and phase

Completed

Phase 2

Phase 1

Conditions

Bone Metastasis

Treatments

Device: Philips MR-guided HIFU system

Study type

Interventional

Funder types

Industry

Identifiers

NCT01309048

02082011

Details and patient eligibility

About

This study is to confirm the safety and technical of MRI guided High Intensity Focused Ultrasound (HIFU) for Palliation for Pain of Skeletal Metastases.

MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate tissue. The MRI system identifies the ultrasound path and monitors heat rise in the tissue. The goal of the study is to show treatment safety and effectiveness. MR-guided HIFU will be performed in patients who pass inclusion/exclusion criteria.

Full description

Bone metastases are common among patients with advanced cancer and have been reported in up to 85% of cancer patients at autopsy. Complications of bone metastases include pain, functional limitation, decreased quality of life, pathological fracture, spinal cord compression and cauda equina syndrome.

External beam radiotherapy is the current standard treatment for patients with painful uncomplicated bone metastases. Unfortunately up to 30 % of patients treated with radiotherapy do not respond to therapy, and 30% of responders have their pain recur at some point after treatment. Radiotherapy re-treatment is also limited by cumulative doses delivered to sensitive structures. Ablative techniques such as cryotherapy and percutaneous radiofrequency ablation are not similarly limited by cumulative effects, however, they are invasive procedures that place patients at risk of complications.

MR-guided high intensity focused ultrasound (MR-HIFU) is a non-invasive, outpatient modality being investigated for the treatment of cancer. In MR-HIFU, a specially designed 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 produces therapeutic hyperthermia in the target field but only harmlessly warms the immediately surrounding tissue. Magnetic resonance (MR) imaging is used both to focus the ultrasound beam on the target field in the bone (the metastatic lesion and adjacent periosteum containing the nerves and vasculature for the tumor) and to perform real-time thermal mapping at and around the target. The mechanism of action of pain response is thought to be thermal periosteal denervation and / or thermal ablation of the tumor mass that diminishes pressure on the surrounding tissue.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥18 years
Able to give informed consent
Weight <140kg
Radiologic evidence of bone metastases from any solid tumor
Able to characterize pain specifically at the site of interest (target lesion)
Pain score related to target lesion of ≥4 on a 0-10 point scale irrespective of medications
Target lesion accessible for MR-HIFU procedure
Target lesion maximum dimension ≤8cm
Target lesion is uncomplicated (i.e.: no fracture / spinal cord compression / cauda equina syndrome / soft tissue component)
Target lesion visible by non-contrast MRI
Interface between bone and skin lies ≥1cm from surface
Able to communicate sensation during MR-HIFU treatment
MR-HIFU treatment date ≥2 weeks from most recent treatment of primary tumor or any chemotherapy.

Exclusion criteria

Prior radiotherapy / surgery / ablative therapy / other local therapy to target lesion.
Unable to characterize pain specifically at the site of interest (target lesion)
Pregnant / Nursing woman
Target lesion is complicated (i.e.: presence of one of fracture / spinal cord compression / cauda equina syndrome / soft tissue component).
Target lesion <1cm from nerve bundles / bladder / bowel
Target lesion in contact with hollow viscera
Target lesion located in skull, spine (excluding sacrum which is allowed) or sternum
Scar along proposed HIFU beam path
Orthopaedic implant along proposed HIFU beam path or at site of target lesion.
Serious cardiovascular, neurological, renal or hematological chronic disease
Active infection
Unable to tolerate required stationary position during treatment
Allergy to MRI contrast agent or sedation