Clinical Trial

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

Study acronym: UFOGUIDE
Unknown
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Record status
This record was last updated July 23, 2024 (before its estimated November 9, 2024 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT04803773
Lead Sponsor University Hospital, Strasbourg, France
Conditions Painful Bone Metastases, Superficial Osteoid Osteoma
Enrollment 15 participants
Start Date 2021-01-19
Primary Completion 2024-11-09 (estimated)
Study Completion 2024-11-09 (estimated)
Updated on ClinicalTrials.gov 2024-07-23