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

Primary Purpose

Painful Bone Metastases, Superficial Osteoid Osteoma

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

UFOGUIDE "patient transducer"

About this trial

This is an interventional device feasibility trial for Painful Bone Metastases focused on measuring thermal ablation, HIFU, Bone metastases, Osteoid Osteoma, Pain, Interventional Radiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpitaux Universitaires de StrasbourgRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Arm

Arm Description

Outcomes

Primary Outcome Measures

Device feasibility

The device feasibility is defined by the ability of the device to induce a hyperthermia on the tumor

Secondary Outcome Measures

Clinical efficacy: - in palliative intent by a decrease ≤3 on visual analogic scale - in curative intent (osteoid osteoma) by a total disappearance in pain

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

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

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.

Safety :number of patients with complications and characterization of complications

Complications recording

Full Information

NCT ID

NCT04803773

First Posted

January 5, 2021

Last Updated

May 16, 2023

Sponsor

University Hospital, Strasbourg, France

1. Study Identification

Unique Protocol Identification Number

NCT04803773

Brief Title

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

Acronym

UFOGUIDE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 19, 2021 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Painful Bone Metastases, Superficial Osteoid Osteoma

Keywords

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

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental Arm

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

UFOGUIDE "patient transducer"

Intervention Description

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.

Primary Outcome Measure Information:

Title

Device feasibility

Description

The device feasibility is defined by the ability of the device to induce a hyperthermia on the tumor

Time Frame

Assessed in real time during the procedure

Secondary Outcome Measure Information:

Title

Clinical efficacy: - in palliative intent by a decrease ≤3 on visual analogic scale - in curative intent (osteoid osteoma) by a total disappearance in pain

Description

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

Time Frame

Before intervention and day 1, day 5 and day 30

Title

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

Description

Time Frame

Before intervention and day 30

Title

Safety :number of patients with complications and characterization of complications

Description

Complications recording

Time Frame

day 1, day 5 and day 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Afshin GANGI, Pr

Phone

03 69 55 07 56

Ext

0033

afshin.gangi@chru-strasbourg.fr

Facility Information:

Facility Name

Hôpitaux Universitaires de Strasbourg

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Afshin GANGI, Pr

Phone

03 69 55 07 56

Ext

0033

afshin.gangi@chru-strasbourg.fr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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