Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases
Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - A Pilot Study
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Locais de estudo
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Ontario
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Toronto, Ontario, Canadá, M4N 3M5
- Sunnybrook Health Sciences Centre
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Patients with painful bone metastasis
Patients with bone metastasis causing pain
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Reduction of Pain Score
Prazo: 90 Days
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Determine the efficacy of MR-Guided HIFU in reducing pain scores related to the site treated as measured on the Brief Pain Inventory (BPI).
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90 Days
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Reduction of Pain Medication
Prazo: 90 Days
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Determine the efficacy of MR-Guided HIFU in reducing pain medication usage
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90 Days
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Complications and Adverse Events
Prazo: 90 Days
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Document complications and adverse events as well as the number of unintended lesions that occur as a result of treatment with MR-Guided HIFU.
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90 Days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes in bone density
Prazo: 90 Days
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Measure changes in bone density between X-ray and CT images taken prior to and following treatment.
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90 Days
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Quality of Life
Prazo: 90 Days
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Measure patient quality of life using both the EORTC QLQ-BM22 and FACT-BP scales
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90 Days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Greg Czarnota, M.D., Radiation Oncology, Sunnybrook Health Sciences Centre
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 02082011
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