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New treatment option for Painful Bone Metastases
Official title MRI-guided Focused Ultrasound : Feasibility Study for the Treatment of Bone Metastases and osteoïd Osteoma
ClinicalTrials.gov ID: NCT04803773
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Strasbourg, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strasbourg, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.