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RecruitingNCT04285125HAMUpdated Jan 5, 2026

High Resolution Imaging for Analysis of MVNT

An observational study in Benign Neuronal Desease, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Recruiting at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-05.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

From the registry’s dates

  • Started Mar 2020; still recruiting 6 years 7 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
33
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Benign Neuronal Desease
03

In context

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with suspicion of MVNT during a first exploratory MRI.

Inclusion criteria

  • 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 :

      • No mass effect
      • Hyposignal T1
  • Having received informed information about the study and having given express consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Contraindication to MRI
  • Patient benefiting from a legal protection measure
  • Pregnant or breastfeeding woman

Secondary exclusion criteria:

- No characterization MRI done

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
33 participants (estimated)
Patient registry
No

Interventions

  • Othercerebral MRI

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 1

07

Study locations

3 of 7 sites recruiting
  • Groupe Hospitalier Pellegrin
    Bordeaux, Bordeaux 33076, France
    Active, not recruiting
  • CHU Rennes
    Rennes, Rennes 35033, France
    Recruiting
  • CHU de Rouen
    Rouen, Rouen 76000, France
    Active, not recruiting
  • Hôpital Pierre Paul Riquet, CHU Purpan
    Toulouse, Toulouse 31059, France
    Active, not recruiting
  • Fondation A De Rothschild
    Paris, 75019, France
    Recruiting
  • Centre Hospitalier Lyon Sud
    Pierre-Bénite, 69495, France
    Active, not recruiting
  • Hôpital Laennec
    Saint-Herblain, 44800, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04285125
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
Feb 26, 2020
Start date
Mar 5, 2020
Primary completion
May 19, 2025
Completion
May 19, 2027 (estimated)
Last update
Jan 5, 2026

Study contacts

Amelie YAVCHITZ, PhD
Contact
ayavchitz@for.paris
0148036454
Augustin Lecler
Contact
alecler@for.paris
0148036401

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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