MRI-guided Focused Ultrasound for Bone Tumors Treatment: Feasibility Study for the Treatment of Bone Metastases and osteoïd Osteoma
Ufoguide is a prospective single arm open study to assess the feasibility of a new type of HIFU system to treat bone tumors. HIFU is classically delivered by a transducer integrated in the MRI table. This study assesses a new type of approach in which the HIFU transducer is manually placed on the skin of the patient, under the assistance of optical navigation, and held in place by MR-compatible passive arms. The primary goal of this study is to assess the feasibility of heating the tumor accurately with this new HIFU system. The evaluation and monitoring of the treatment will be performed by MR thermometry. Secondary endpoints include the evaluation of clinical efficacy, quality of life and safety.
• Subject with one or more painful bone metastases (EVA≥5)
• Subject with sub-perolate or cortical osteoid osteoma
• For people with painful bone metastases: first-line treatment or radiotherapy failure
• Weight \< 140kg.
• Target tumor accessible by HIFU-MRI
• Maximum size of the lesion - 20cm²
• Depth of the lesion to be treated - 4mm and 10cm
• Subject affiliated with a health insurance social protection.
• A subject capable of understanding research objectives and risks and giving informed and signed consent
• Subject who has been informed of the pre-medical visit results