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

Painful Bone Metastases Clinical Trial

— UFOGUIDE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04803773
• Other study ID #: 7677
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Strasbourg, France
• Contact: Afshin GANGI, Pr
• Phone: 03 69 55 07 56
• Email: afshin.gangi[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Neoplasms
• Neoplasm Metastasis
• Osteoma, Osteoid
• Painful Bone Metastases
• Superficial Osteoid Osteoma

Intervention

Device:
• UFOGUIDE "patient transducer"
The transducer is maintained by a flexible/rigid structure, consisting of a support base, and three to four feet forming an arch around the area to be treated. These feet exist in several lengths (10, 20, 30, 40 cm) depending on the area to be treated and can be easily mounted on the base by fast attachment. The structure is based on the principle of granular jamming: it is flexible in its normal state, and can be stiffened by the application of depression within the feet.

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device feasibility	The device feasibility is defined by the ability of the device to induce a hyperthermia on the tumor	Assessed in real time during the procedure
Secondary	Clinical efficacy: - in palliative intent by a decrease =3 on visual analogic scale - in curative intent (osteoid osteoma) by a total disappearance in pain	Clinical efficacy is defined: in palliative intent by a decrease =3 on visual analogic scale; in curative intent (osteoid osteoma) by a total disappearance in pain	Before intervention and day 1, day 5 and day 30
Secondary	Quality of life using the EORTC (European Organisation for Research and Treatment of Cancer) quality of life questionnaire	EORTC quality of life questionnaire is composed of multi-items scales and single-item measures. All of the scales measures range in score from 0 to 100. A High scale score represents a higher response level.	Before intervention and day 30
Secondary	Safety :number of patients with complications and characterization of complications	Complications recording	day 1, day 5 and day 30