Painful Bone MetastasesUFOGUIDENCT04803773
MRI-guided Focused Ultrasound : Feasibility Study for the Treatment of Bone Metastases and osteoïd Osteoma
A study testing UFOGUIDE "patient transducer" in people with Painful Bone Metastases and Superficial Osteoid Osteoma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Bone Metastases, Superficial Osteoid Osteoma
- What is being tested?
- UFOGUIDE "patient transducer"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2021to 9 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Afshin GANGI, Pr, 03 69 55 07 56 ext. 0033, afshin.gangi@chru-strasbourg.fr
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- UFOGUIDE "patient transducer"
- Keywords
- thermal ablation, HIFU, Bone metastases, Osteoid Osteoma, Pain, Interventional Radiology
- Medical subject headings
- Osteoma, Osteoid, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Not described Receives: Device: UFOGUIDE "patient transducer" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device feasibility
The device feasibility is defined by the ability of the device to induce a hyperthermia on the tumor
Measured: 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
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
Measured: 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
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.
Measured: Before intervention and day 30
Safety :number of patients with complications and characterization of complications
Complications recording
Measured: day 1, day 5 and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start19 Jan 2021
- Primary completion9 Nov 2024 (estimated)
- Study completion9 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Bone MetastasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803773
- Sponsor's protocol ID
- 7677
- Acronym
- UFOGUIDE
- Status last verified
- Jul 2024
- First submitted
- 5 Jan 2021
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-guided Focused Ultrasound for Bone Tumors Treatment: Feasibility Study for the Treatment of Bone Metastases and osteoïd Osteoma
- ClinicalTrials.gov ID
- NCT04803773
- Acronym / sponsor ID
- UFOGUIDE / 7677
- Keywords
- thermal ablation, HIFU, Bone metastases, Osteoid Osteoma, Pain, Interventional Radiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 9 Nov 2024 (estimated)
- Study completion
- 9 Nov 2024 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Device: UFOGUIDE "patient transducer" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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, ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Experimental Arm |
Primary outcome
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
3 secondary outcomes
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
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
Safety :number of patients with complications and characterization of complications
Time frame: day 1, day 5 and day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UFOGUIDE "patient transducer" in people with Painful Bone Metastases and Superficial Osteoid Osteoma, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Afshin GANGI, Pr (03 69 55 07 56 ext. 0033, afshin.gangi@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device feasibility (time frame: Assessed in real time during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.