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RECRUITING
NCT04803773
NA

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

Sponsor: University Hospital, Strasbourg, France

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2021-01-19

Completion Date

2024-11-09

Last Updated

2024-07-23

Healthy Volunteers

No

Interventions

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 (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, France