Pilot Study for Palliation of Pain in Bone Metastases by MR-HIFU
Condition: Secondary Malignant Neoplasm of Bone
MeSH terms: Neoplasm Metastasis; Neoplasms; Bone Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed description: 
      Bone is the third most common site of metastases spread after the liver and the lungs, with a
      great incidence in breast, prostate, lung, kidney and thyroid cancers. For example, 90% of
      patients dying from breast cancer and most of patients with advanced prostate cancer suffer
      from bone metastases, which are frequently responsible of chronic pain and lead to an
      increase in morbidity and mortality with pathological fractures, compression syndrome and
      hypercalcemia..Moreover, the increasing longevity of patients with cancer resulting from the
      improvement of the effectiveness of the treatments leads to a higher incidence and prevalence
      of metastating bone lesions.

      Palliative treatment with management of pain and improvement of quality of life remains the
      first goal of therapy. Current treatments options include systemic drug therapy
      (chemotherapy, hormonal therapy, analgesics and bi-phosphonates), local invasive treatment
      (surgery), local mini-invasive treatment with interventional radiological techniques
      (cimentoplasty, cryotherapy and radiofrequency ablation) and radiation therapy.

      External-beam radiation therapy remains the current standard of care for patients with bone
      metastases in first intention. However, up to 20-30 % of patients treated do not experience
      pain relief and recurrence of pain appear in 27 % after treatment. Moreover radiation
      treatment is limited due to accumulation of dose. Since few years, cryotherapy and
      percutaneous radiofrequency ablation have shown good results in management of pain with bone
      metastases, however these techniques are still invasive.

      In MRI-guided High Intensity Focused Ultrasound (HIFU), the ultrasound generated by the
      transducer is focused into a small focal tissue volume at specific target locations. During
      treatment, the beam of focused ultrasound energy penetrates through soft tissue and causes
      localized temperatures elevation up 55-70°C for a few seconds within the target producing
      well defined regions of irreversible protein denaturation, cell damage, and coagulative
      necrosis. A single exposure of focused ultrasound energy is called a "sonication." Multiple
      sonications are necessary to ablate the targeted tissue. Tight focusing is designed to limit
      the ablation to the targeted location.

      Applying HIFU energy to a patient's lesion requires treatment planning, targeting of the
      ultrasound (US) beam to desired locations and monitoring of the energy delivery. In some
      applications this can be performed using diagnostic ultrasound imaging in combination with
      the HIFU. While diagnostic US provides some anatomical details and helps with procedure
      planning and treatment targeting, it does not provide 3D planning, means of measuring the
      temperature increase generated by HIFU, or metrics for quantifying the energy/dose delivered
      to the treatment zone. Currently, only MR imaging can provide a validated non-invasive
      temperature measurement and thermal dose quantification in the treated tissue. Furthermore,
      these real-time MR temperature measurements can be used to control the HIFU system to deliver
      optimal temperatures to the target locations. The Philips MR-guided focused ultrasound system
      will provide real-time tissue temperature mapping in multiple planes and control of the
      temperature delivering dose to the target location. Recent advances in MR temperature mapping
      make it possible to achieve temperature accuracy of 1°C in stationary soft tissues.
    

Intervention name(s): High Intensity Focused Ultrasound
Intervention type(s): Device
Intervention description(s): HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein and nerve denaturation, irreversible cell damage, and coagulative necrosis.
Other intervention name(s): • HIFU; • Ablation; • High Intensity Focused Ultrasound
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: bone metastasis; pain palliation