Benign Neuronal DeseaseMIAMNCT04103190
Multiparametric Imaging for Analysis of MVNT (Multinodular and Vacuolating Neuronal Tumor)
An observational study of Benign Neuronal Desease, run by Fondation Ophtalmologique Adolphe de Rothschild at 7 sites in France.
Trial summary
Differential diagnoses of MVNT include DNT (dysembryoplastic neuroepithelial tumor), low-grade gliomas, cortical dysplasias or even hamartomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Neuronal Desease
- What is being tested?
- cerebral MRI
- Type of treatment
- Medical device
- How many people
- 71 participants
- Where
- 7 sitesFrance
- Study dates
- 10 Dec 2019to 10 Jul 2025
- Phase
- Observational
- 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
Study population: Patient supported for suspicion of MVNT
Who may be able to join
- Patient over 18 years old
- Suspicion of MVNT on an MRI: it is considered that it will be necessary at least the 2 major criteria associated with at least 1 minor criterion to enter the definition of suspicion of MVNT:
- Major criteria:
- Multinodular aspect in cluster
- High FLAIR hypersignal / T2
- Minor criteria:
Show all 11Show fewer
- Absence of mass effect
- Hyposignal T1
- Center of the lesion in hypsignal FLAIR or T1 hypersignal
- Affiliate or beneficiary of a Social Security scheme
- Having received informed information about the study and consenting to participate in the study
Who cannot join
- Patient benefiting from a legal protection measure
- Pregnant or lactating woman
- Contraindication to MRI
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Groupe Hospitalier Pellegrin
Bordeaux, Bordeaux, 33076
Fondation Adolphe de Rothschild
Paris, PARIS, 75019
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
CHU Rennes
Rennes, Rennes, 35033
CHU de Rouen
Rouen, Rouen, 76000
Hôpital Laennec
Saint-Herblain, 44800
Hôpital Pierre Paul Riquet, CHU Purpan
Toulouse, Toulouse, 31059
About this study
Differential diagnoses of MVNT include DNT (dysembryoplastic neuroepithelial tumor), low-grade gliomas, cortical dysplasias or even hamartomas.
Read the detailed description
Differential diagnoses of MVNT include DNT (dysembryoplastic neuroepithelial tumor), low-grade gliomas, cortical dysplasias or even hamartomas.
However, in order to avoid an invasive surgical procedure to remove the lesion, a certain diagnosis of its benignity is essential. The contribution of advanced techniques in MRI, such as spectroscopy in the characterization of these lesions, has not yet been studied today
- Conditions
- Benign Neuronal Desease
- Being tested
- cerebral MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebral MRIDevice
Patients who agree to participate in the study will perform a 3T multi-parametric MRI with advanced spectroscopic imaging techniques and standard protocol.
A neurological consultation will take place during the inclusion visit as well as a questionnaire and a control MRI at 1 year and 2 years +/- 1 month.
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of a new radiological entity on Spectroscopy : the MVNT (Multinodular and Vacuolating Neuronal Tumor)
ratio of N-Acetylaspartate / Choline on Spectroscopy
Measured: 1 day
Description of a new radiological entity on Spectroscopy : the MVNT (Multinodular and Vacuolating Neuronal Tumor)
area under curve of the N-Acetylaspartate Spectroscopie
Measured: 1 day
Description of a new radiological entity on Spectroscopy : : the MVNT (Multinodular and Vacuolating Neuronal Tumor)
area under curve of choline Spectroscopie
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start10 Dec 2019
- Primary completion10 Jul 2023
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Neuronal DeseaseStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103190
- Sponsor's protocol ID
- ALR_2019_4
- Acronym
- MIAM
- Status last verified
- Dec 2025
- First submitted
- 21 Jun 2019
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Imaging for Analysis of MVNT (Multinodular and Vacuolating Neuronal Tumor)
- ClinicalTrials.gov ID
- NCT04103190
- Acronym / sponsor ID
- MIAM / ALR_2019_4
- Conditions
- Benign Neuronal Desease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 25 Sep 2019 (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.
Differential diagnoses of MVNT include DNT (dysembryoplastic neuroepithelial tumor), low-grade gliomas, cortical dysplasias or even hamartomas.
Detailed description
Differential diagnoses of MVNT include DNT (dysembryoplastic neuroepithelial tumor), low-grade gliomas, cortical dysplasias or even hamartomas.
However, in order to avoid an invasive surgical procedure to remove the lesion, a certain diagnosis of its benignity is essential. The contribution of advanced techniques in MRI, such as spectroscopy in the characterization of these lesions, has not yet been studied today
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient supported for suspicion of MVNT
Key inclusion criteria (11 listed)
- Patient over 18 years old
- Suspicion of MVNT on an MRI: it is considered that it will be necessary at least the 2 major criteria associated with at least 1 minor criterion to enter the definition of suspicion of MVNT:
- Multinodular aspect in cluster
- High FLAIR hypersignal / T2
- Absence of mass effect
Key exclusion criteria (3 listed)
- Patient benefiting from a legal protection measure
- Pregnant or lactating woman
- Contraindication to MRI
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 |
|---|---|---|
| cerebral MRIPatients who agree to participate in the study will perform a 3T multi-parametric MRI with advanced spectroscopic imaging techniques and standard protocol. A neurological consultation will take place during the inclusion visit as well as a questionnaire and a control MRI at 1 year and 2 years +/- 1 month. | Device | – |
Primary outcome
Description of a new radiological entity on Spectroscopy : the MVNT (Multinodular and Vacuolating Neuronal Tumor)
Time frame: 1 day
ratio of N-Acetylaspartate / Choline on Spectroscopy
Description of a new radiological entity on Spectroscopy : the MVNT (Multinodular and Vacuolating Neuronal Tumor)
Time frame: 1 day
area under curve of the N-Acetylaspartate Spectroscopie
Description of a new radiological entity on Spectroscopy : : the MVNT (Multinodular and Vacuolating Neuronal Tumor)
Time frame: 1 day
area under curve of choline Spectroscopie
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 5 Jan 2026.
Related trials for Benign Neuronal Desease
RecruitingObservational study
High Resolution Imaging for Analysis of MVNT
Benign Neuronal Desease
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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Neuronal Desease, run by Fondation Ophtalmologique Adolphe de Rothschild at 7 sites 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 11 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 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Description of a new radiological entity on Spectroscopy : the MVNT (Multinodular and Vacuolating Neuronal Tumor) (time frame: 1 day). The study lists 3 primary outcomes in all. 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 5 Jan 2026.