MRI-guided Focused Ultrasound : Feasibility Study for the Treatment of Bone Metastases and osteoï… (NCT04803773) | Clinical Trial Compass
RecruitingNot Applicable
MRI-guided Focused Ultrasound : Feasibility Study for the Treatment of Bone Metastases and osteoïd Osteoma
France15 participantsStarted 2021-01-19
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Device feasibility
Timeframe: Assessed in real time during the procedure