Status:
RECRUITING
MRI-guided Focused Ultrasound : Feasibility Study for the Treatment of Bone Metastases and osteoïd Osteoma
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Painful Bone Metastases
Superficial Osteoid Osteoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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....
Detailed Description
Ufoguide is a prospective single arm open study to assess the feasibility of a new type of HIFU system for the treatment of painful metastases (palliative intent) and osteoid osteoma (curative intent)...
Eligibility Criteria
Inclusion
- 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
Exclusion
- MRI contraindication
- Contraindication to the use of a gadolinium contrast or hypersensitivity to gadoteric acid, meglumine or any drug containing gadolinium
- General anesthesia contraindication
- Non-reversible hemostasis disorders
- Previous injury on the area to be treated (radiotherapy, surgery, ...)
- Tumors located on the spine or skull
- Tumors located on the ribs
- Pathological fracture
- For Osteoid Osteoma: nidus more than 1cm deep within cortical bone
- Pregnant woman (pregnancy test, urinary or HCG dosage, negative to inclusion) or lactating
- existence of dermatological pathologies
- Subject with a known latex allergy
- Subject under safeguarding of justice, under guardianship or curatorship
- Subject in an exclusion period by a previous or ongoing study
Key Trial Info
Start Date :
January 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 9 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04803773
Start Date
January 19 2021
End Date
November 9 2024
Last Update
July 23 2024
Active Locations (1)
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1
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67000