MRI-guided Focused Ultrasound : Feasibility Study for the Treatment of Bone Metastases and osteoïd Osteoma (UFOGUIDE)

University Hospital, Strasbourg, France

Status

Enrolling

Conditions

Superficial Osteoid Osteoma

Painful Bone Metastases

Treatments

Device: UFOGUIDE "patient transducer"

Study type

Interventional

Funder types

Other

Identifiers

NCT04803773

7677

Details and patient eligibility

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.

Full 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).

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 and held in place by MR-compatible passive arms. Optical infrared navigation is used to help the physician with the positioning of the HIFU transducer.

The primary goal of this study is to assess the feasibility of heating the tumor accurately with this new HIFU system. The evaluation and control of the treatment will be performed by Proton Resonance Frequency Shift (PRFS) MR thermometry.

Secondary endpoints include the evaluation of clinical efficacy, quality of life and safety.

Clinical efficacy is defined:

in palliative intent by a decrease ≤3 on visual analogic scale
in curative intent (osteoid osteoma) by a total disappearance of pain Quality of life is assessed by EORTC quality of life questionnaire-core 30 items Complications are recorded to assess safety.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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