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

NCT04803773 | Recruiting

• 1 other identifier: 7677
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Painful Bone Metastases; Superficial Osteoid Osteoma

Keywords

thermal ablation; HIFU; Bone metastases; Osteoid Osteoma; Pain; Interventional Radiology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical efficacy: - 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

• Quality of life using the EORTC (European Organisation for Research and Treatment of Cancer) quality of life questionnaire

  Before intervention and day 30

• Safety :number of patients with complications and characterization of complications

  day 1, day 5 and day 30

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Device: UFOGUIDE "patient transducer"

Interventions

UFOGUIDE "patient transducer" DEVICE

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.

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• existence of dermatological pathologies
• Subject with a known latex allergy
• Subject under safeguarding of justice, under guardianship or curatorship

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Conditions

Osteoma, Osteoid; Pain

Condition Hierarchy (Ancestors)

Osteoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Afshin GANGI, Pr

CONTACT

03 69 55 07 56; afshin.gangi@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: March 18, 2021
• Study Start: January 19, 2021
• Primary Completion: November 9, 2024
• Study Completion: November 9, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)