Actively Recruiting
MRI-guided Focused Ultrasound : Feasibility Study for the Treatment of Bone Metastases and osteoïd Osteoma
Led by University Hospital, Strasbourg, France · Updated on 2024-07-23
15
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MRI-guided Focused Ultrasound : Feasibility Study for the Treatment of Bone Metastases and osteoïd Osteoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- One or more painful bone metastases with a pain score of 5 or higher
- Sub-periosteal or cortical osteoid osteoma
- For painful bone metastases, first-line treatment or radiotherapy failure
- Weight less than 140 kg
- Target tumor accessible by HIFU-MRI
- Maximum lesion size of 20 cm squared
- Lesion depth between 4 mm and 10 cm
- Affiliated with a health insurance social protection
- Able to understand research objectives and risks and provide informed signed consent
- Informed of pre-medical visit results
You will not qualify if you...
- Contraindication to MRI
- Contraindication or hypersensitivity to gadolinium contrast agents (gadoteric acid, meglumine, or any gadolinium-containing drug)
- Contraindication to general anesthesia
- Non-reversible blood clotting disorders
- Previous injury to the treatment area (radiotherapy, surgery, etc.)
- Tumors located on the spine or skull
- Tumors located on the ribs
- Presence of pathological fracture
- For osteoid osteoma, nidus located more than 1 cm deep within cortical bone
- Pregnant or lactating women
- Existing skin diseases
- Known latex allergy
- Under legal protection such as guardianship or curatorship
- Participation in another study with exclusion period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67000
Actively Recruiting
Research Team
A
Afshin GANGI, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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