Using MRI-guided Focused Ultrasound to treat painful bone tumors
MRI-guided Focused Ultrasound for Bone Tumors Treatment: Feasibility Study for the Treatment of Bone Metastases and osteoïd Osteoma
NA · University Hospital, Strasbourg, France · NCT04803773
This study is testing a new way to treat painful bone tumors using focused ultrasound to see if it can help relieve pain and improve quality of life for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France (other) |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT04803773 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of a novel high-intensity focused ultrasound (HIFU) system for treating painful bone metastases and osteoid osteoma. Unlike traditional methods, the HIFU transducer is manually placed on the patient's skin and guided by optical navigation, allowing for precise targeting of tumors. The primary goal is to assess the accuracy of tumor heating using MR thermometry, while secondary endpoints include evaluating clinical efficacy, quality of life, and safety. The study aims to provide insights into a new approach for managing bone tumors.
Who should consider this trial
Good fit: Ideal candidates include individuals with painful bone metastases or superficial osteoid osteoma who have not responded to first-line treatments.
Not a fit: Patients with contraindications for MRI or those with tumors located on the spine or skull may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a non-invasive treatment option for patients suffering from painful bone tumors.
How similar studies have performed: While the use of HIFU for bone tumors is being explored, this specific approach with optical navigation is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Strasbourg
- Hôpitaux Universitaires de Strasbourg — Strasbourg, France (RECRUITING)
Study contacts
- Study coordinator: Afshin GANGI, Pr
- Email: afshin.gangi@chru-strasbourg.fr
- Phone: 03 69 55 07 56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Painful Bone Metastases, Superficial Osteoid Osteoma, thermal ablation, HIFU, Bone metastases, Osteoid Osteoma, Pain, Interventional Radiology