Cerebral TumorEUHF_PRCNCT03179176
Evaluation of the Interest of Ultra-high Frequency Doppler Ultrasound (UFDU) in the Surgical Management of Patients Operated in an Awake Condition for a Cerebral Tumor
A study testing High Frequence Ultrasound Doppler (HFUD) utilisation in people with Cerebral Tumor, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
In brain tumor surgery we are confronted mainly with two types of difficulties: (i) the identification of the tumor and its limitations in relation to the healthy brain; (ii) the identification of functional cerebral regions, ie implicated in neurological function (motor skills, sensitivity, language, vision… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Tumor
- What is being tested?
- High Frequence Ultrasound Doppler (HFUD) utilisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2017to 25 Apr 2018
- 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
- operated patient of a cerebral tumor in an awake condition
- age> 18 years
- neurological condition allowing the realization of the tests in the operating room
Who cannot join
- not indicated for "awake" surgery
- refusal of participation of the patient
- pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
About this study
In brain tumor surgery we are confronted mainly with two types of difficulties: (i) the identification of the tumor and its limitations in relation to the healthy brain; (ii) the identification of functional cerebral regions, ie implicated in neurological function (motor skills, sensitivity, language, vision, cognition, etc.). The reference method currently used to improve the quality of resection of brain tumors while minimizing neurological risk for patients is so called "wakeful" surgery with direct electrical stimulation (DES) of the brain. The investigators routinely use ultrasound to localize the tumor within the brain, but to date there is no pre- or intra-operative imaging tool to reliably identify tumors and functional brain regions. There is therefore a need for innovative imaging in this field.
For this reason, the investigators propose to evaluate the interest of a new High Frequence Ultrasound Doppler (HFUD) (VEVO ®, Visualsonics, Toronto, Canada) in the surgical management of patients operated in an awake condition for a brain tumor. The ultra high frequency allows to reach a spatial resolution of 30 μm, 5 to 10 times better than MRI and conventional ultrasound. The Doppler mode allows the detection of microvascular flows of speeds less than 1 mm / second. The safety of this device is demonstrated and validated by CE marking (December 2015).
- Conditions
- Cerebral Tumor
- Being tested
- High Frequence Ultrasound Doppler (HFUD) utilisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Frequence Ultrasound Doppler (HFUD) utilisationOther
Utilisation of HFUD will be done during on patients during an operation in waking condition. This procedure extends the usual procedure from 15 to 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| HFUD utilisation | Experimental | Not described Receives: Other: High Frequence Ultrasound Doppler (HFUD) utilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter of the sulcus blood vessels
Measured: before resection of the tumor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start25 Apr 2017
- Primary completion25 Apr 2018
- Study completion25 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral TumorStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabien ALMAIRAC, MD, Study director, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179176
- Sponsor's protocol ID
- 17-PP-01
- Acronym
- EUHF_PRC
- Status last verified
- Feb 2024
- First submitted
- 29 May 2017
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Almairac F, Fontaine D, Demarcy T, Delingette H, Beuil S, Raffaelli C. Motor cortex neurovascular coupling: inputs from ultra-high-frequency ultrasound imaging in humans. J Neurosurg. 2018 Nov 9;131(5):1632-1638. doi: 10.3171/2018.5.JNS18754. Print 2019 Nov 1.
PubMed 30497179
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Interest of Ultra-high Frequency Doppler Ultrasound (UFDU) in the Surgical Management of Patients Operated in an Awake Condition for a Cerebral Tumor
- ClinicalTrials.gov ID
- NCT03179176
- Acronym / sponsor ID
- EUHF_PRC / 17-PP-01
- Conditions
- Cerebral Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 7 Jun 2017 (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.
In brain tumor surgery we are confronted mainly with two types of difficulties: (i) the identification of the tumor and its limitations in relation to the healthy brain; (ii) the identification of functional cerebral regions, ie implicated in neurological function (motor skills, sensitivity, language, vision, cognition, etc.). The reference method currently used to improve the quality of resection of brain tumors while minimizing neurological risk for patients is so called "wakeful" surgery with direct electrical stimulation (DES) of the brain. The investigators routinely use ultrasound to localize the tumor within the brain, but to date there is no pre- or intra-operative imaging tool to reliably identify tumors and functional brain regions. There is therefore a need for innovative imaging in this field.
For this reason, the investigators propose to evaluate the interest of a new High Frequence Ultrasound Doppler (HFUD) (VEVO ®, Visualsonics, Toronto, Canada) in the surgical management of patients operated in an awake condition for a brain tumor. The ultra high frequency allows to reach a spatial resolution of 30 μm, 5 to 10 times better than MRI and conventional ultrasound. The Doppler mode allows the detection of microvascular flows of speeds less than 1 mm / second. The safety of this device is demonstrated and validated by CE marking (December 2015).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HFUD utilisation | Experimental | Other: High Frequence Ultrasound Doppler (HFUD) utilisation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- operated patient of a cerebral tumor in an awake condition
- age> 18 years
- neurological condition allowing the realization of the tests in the operating room
Key exclusion criteria (3 listed)
- not indicated for "awake" surgery
- refusal of participation of the patient
- pregnant or nursing women
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 |
|---|---|---|
| High Frequence Ultrasound Doppler (HFUD) utilisationUtilisation of HFUD will be done during on patients during an operation in waking condition. This procedure extends the usual procedure from 15 to 20 minutes. | Other | HFUD utilisation |
Primary outcome
Diameter of the sulcus blood vessels
Time frame: before resection of the tumor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Derived from this study: PubMed 30497179Almairac F, Fontaine D, Demarcy T, Delingette H, Beuil S, Raffaelli C. Motor cortex neurovascular coupling: inputs from ultra-high-frequency ultrasound imaging in humans. J Neurosurg. 2018 Nov 9;131(5):1632-1638. doi: 10.3171/2018.5.JNS18754. Print 2019 Nov 1.
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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.
Fabien ALMAIRAC, MD study director
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Frequence Ultrasound Doppler (HFUD) utilisation in people with Cerebral Tumor, run by Centre Hospitalier Universitaire de Nice 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 6 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diameter of the sulcus blood vessels (time frame: before resection of the tumor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03179176, which also lists 1 linked publication.
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 6 Feb 2024.