Benign Neuronal DeseaseHAMNCT04285125
High Resolution Imaging for Analysis of MVNT
An observational study of Benign Neuronal Desease, run by Fondation Ophtalmologique Adolphe de Rothschild at 7 sites in France.
Trial summary
MVNT (multinodular and vacuolating neuronal tumor of the cerebrum) is a benign, recently discovered, neuronal lesion, the incidence of which is unknown. It seems to predominate in the temporal lobes and presents a characteristic MRI appearance: multiple subcortical nodules, developed at the white substance / gray… 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
- How many people
- 33 participants
- Where
- 7 sitesFrance
- Study dates
- 5 Mar 2020to 19 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with suspicion of MVNT during a first exploratory MRI.
Who may be able to join
- Patient over 18 years of age
- Prospective inclusion of all patients with suspected MVNT on a first exploratory MRI: at least the 2 major criteria associated with at least 1 minor criterion will be required to fit into the definition of suspected MVNT:
- Major criteria :
- Multinomodular clustered appearance
- Franc hypersignal FLAIR/T2
- Minor criteria :
Show all 9Show fewer
- No mass effect
- Hyposignal T1
- Having received informed information about the study and having given express consent to participate in the study
Who cannot join
- Contraindication to MRI
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
- Secondary exclusion criteria:
- No characterization MRI done
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 3 recruiting
- Active, not recruiting
Groupe Hospitalier Pellegrin
Bordeaux, Bordeaux, 33076
- Recruiting
Fondation A De Rothschild
Paris, 75019
Augustin Lecler, alecler@for.paris
- Active, not recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
- Recruiting
CHU Rennes
Rennes, Rennes, 35033
Béatrice Carsin-Nicol, MD PhD, Beatrice.CARSIN.NICOL@chu-rennes.fr
- Active, not recruiting
CHU de Rouen
Rouen, Rouen, 76000
- Recruiting
Hôpital Laennec
Saint-Herblain, 44800
Jesus AGUILLAR, MD PhD, elisabeth.calvier@chu-nantes.fr
- Active, not recruiting
Hôpital Pierre Paul Riquet, CHU Purpan
Toulouse, Toulouse, 31059
About this study
Official title: High Resolution Imaging for Analysis of Multinodular and Vacuolating Neuronal Tumor of the Cerebrum
MVNT (multinodular and vacuolating neuronal tumor of the cerebrum) is a benign, recently discovered, neuronal lesion, the incidence of which is unknown.
It seems to predominate in the temporal lobes and presents a characteristic MRI appearance: multiple subcortical nodules, developed at the white substance / gray substance junction, of variable size, well limited, in iso-hyposignal T1, hypersignal T2 and hypersignal FLAIR.
Read more
The articles describing this entity report the lack of scalability in MRI during patient monitoring, going in the direction of the benignity of the lesion.
The diagnosis sometimes remains uncertain with current MRI sequences, and the patient risks undergoing invasive surgery to remove a lesion that is actually benign. Hence the importance of developing the most precise diagnostic criteria possible. The contribution of advanced MRI techniques, such as ultra-high resolution sequences in the characterization of these lesions, has not yet been studied.
- 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 MRIOther
Patients who agree to participate in the study will perform an MRI with ultra high resolution sequences added by the research MRI of control will be done at one year and two years
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the proportion of patients with a central T2 / FLAIR hyposignal visible on standard sequences and on ultra-high resolution sequences.
Among the patients with confirmation of the diagnosis of MVNT (Multinodular and Vacuolating Neuronal Tumor) on the characterization MRI
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start5 Mar 2020
- Primary completion19 May 2025
- Study completion19 May 2027 (estimated)
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
- Prospective
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285125
- Sponsor's protocol ID
- ALR_2019_16
- Acronym
- HAM
- Status last verified
- Dec 2025
- First submitted
- 1 Oct 2019
- Last updated
- 5 Jan 2026
- 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 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Imaging for Analysis of Multinodular and Vacuolating Neuronal Tumor of the Cerebrum
- ClinicalTrials.gov ID
- NCT04285125
- Acronym / sponsor ID
- HAM / ALR_2019_16
- Conditions
- Benign Neuronal Desease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 19 May 2027 (estimated)
- First posted
- 26 Feb 2020 (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.
MVNT (multinodular and vacuolating neuronal tumor of the cerebrum) is a benign, recently discovered, neuronal lesion, the incidence of which is unknown.
It seems to predominate in the temporal lobes and presents a characteristic MRI appearance: multiple subcortical nodules, developed at the white substance / gray substance junction, of variable size, well limited, in iso-hyposignal T1, hypersignal T2 and hypersignal FLAIR.
The articles describing this entity report the lack of scalability in MRI during patient monitoring, going in the direction of the benignity of the lesion.
The diagnosis sometimes remains uncertain with current MRI sequences, and the patient risks undergoing invasive surgery to remove a lesion that is actually benign. Hence the importance of developing the most precise diagnostic criteria possible. The contribution of advanced MRI techniques, such as ultra-high resolution sequences in the characterization of these lesions, has not yet been studied.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspicion of MVNT during a first exploratory MRI.
Key inclusion criteria (9 listed)
- Patient over 18 years of age
- Prospective inclusion of all patients with suspected MVNT on a first exploratory MRI: at least the 2 major criteria associated with at least 1 minor criterion will be required to fit into the definition of suspected MVNT:
- Having received informed information about the study and having given express consent to participate in the study
Key exclusion criteria (5 listed)
- Contraindication to MRI
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
- No characterization MRI done
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 an MRI with ultra high resolution sequences added by the research MRI of control will be done at one year and two years | Other | – |
Primary outcome
Comparison of the proportion of patients with a central T2 / FLAIR hyposignal visible on standard sequences and on ultra-high resolution sequences.
Time frame: Day 1
Among the patients with confirmation of the diagnosis of MVNT (Multinodular and Vacuolating Neuronal Tumor) on the characterization MRI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- 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.
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 9 inclusion and 5 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelie YAVCHITZ, PhD (0148036454, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the proportion of patients with a central T2 / FLAIR hyposignal visible on standard sequences and on ultra-high resolution sequences. (time frame: Day 1). 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.