{
"info": {
"nct_id": "NCT04803773",
"official_title": "MRI-guided Focused Ultrasound for Bone Tumors Treatment: Feasibility Study for the Treatment of Bone Metastases and osteoïd Osteoma",
"inclusion_criteria": "* Subject with one or more painful bone metastases (EVA≥5)\n* Subject with sub-perolate or cortical osteoid osteoma\n* For people with painful bone metastases: first-line treatment or radiotherapy failure\n* Weight < 140kg.\n* Target tumor accessible by HIFU-MRI\n* Maximum size of the lesion - 20cm²\n* Depth of the lesion to be treated - 4mm and 10cm\n* Subject affiliated with a health insurance social protection.\n* A subject capable of understanding research objectives and risks and giving informed and signed consent\n* Subject who has been informed of the pre-medical visit results\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* MRI contraindication\n* Contraindication to the use of a gadolinium contrast or hypersensitivity to gadoteric acid, meglumine or any drug containing gadolinium\n* General anesthesia contraindication\n* Non-reversible hemostasis disorders\n* Previous injury on the area to be treated (radiotherapy, surgery, ...)\n* Tumors located on the spine or skull\n* Tumors located on the ribs\n* Pathological fracture\n* For Osteoid Osteoma: nidus more than 1cm deep within cortical bone\n* Pregnant woman (pregnancy test, urinary or HCG dosage, negative to inclusion) or lactating\n* existence of dermatological pathologies\n* Subject with a known latex allergy\n* Subject under safeguarding of justice, under guardianship or curatorship\n* Subject in an exclusion period by a previous or ongoing study",
"miscellaneous_criteria": ""
},
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"cortical"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "sub-perolate or cortical osteoid osteoma",
"criterion": "osteoid osteoma",
"requirement": {
"requirement_type": "location",
"expected_value": "sub-perolate"
}
},
{
"exact_snippets": "sub-perolate or cortical osteoid osteoma",
"criterion": "osteoid osteoma",
"requirement": {
"requirement_type": "location",
"expected_value": "cortical"
}
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}