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NCT04803773: UFOGUIDE

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

Recruiting now NA Last updated 23 July 2024
What this trial tests

NA trial testing UFOGUIDE "patient transducer" in Painful Bone Metastases in 15 participants. Currently enrolling.

Timeline
19 January 2021
Primary endpoint
9 November 2024
9 November 2024

Quick facts

Lead sponsorUniversity Hospital, Strasbourg, France
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposedevice feasibility
Enrollment15
Start date19 January 2021
Primary completion9 November 2024
Estimated completion9 November 2024
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Strasbourg, France

Who can join

18 and older, any sex, with Painful Bone Metastases or Superficial Osteoid Osteoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immunomodulation and targeted drug delivery with high intensity focused ultrasound (HIFU): Principles and mechanisms.
    Ashar H, Ranjan A. · · 2023 · cited 41× · PMID 36965581 · DOI 10.1016/j.pharmthera.2023.108393
  2. A new versatile MR-guided high-intensity focused ultrasound (HIFU) device for the treatment of musculoskeletal tumors.
    Cabras P, Auloge P, Bing F, Rao PP, et al · · 2022 · cited 10× · PMID 35641597 · DOI 10.1038/s41598-022-13213-1

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Other University Hospital, Strasbourg, France trials

Trials by the same sponsor.

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