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

May 16, 2023 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device feasibility
Time Frame: Assessed in real time during the procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical efficacy: - in palliative intent by a decrease ≤3 on visual analogic scale - in curative intent (osteoid osteoma) by a total disappearance in pain
Time Frame: Before intervention and day 1, day 5 and day 30

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
Quality of life using the EORTC (European Organisation for Research and Treatment of Cancer) quality of life questionnaire
Time Frame: Before intervention and day 30
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
Safety :number of patients with complications and characterization of complications
Time Frame: day 1, day 5 and day 30
Complications recording
day 1, day 5 and day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2021

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7677

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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