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Recruiting NCT04285125

High Resolution Imaging for Analysis of MVNT

Observational Benign Neuronal Desease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cerebral MRI.
Who it may be relevant to
Registry conditions: Benign Neuronal Desease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

High Resolution Imaging for Analysis of Multinodular and Vacuolating Neuronal Tumor of the Cerebrum

Overview

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.

Interventions

  • Other cerebral 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

Primary outcome measures

  • 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]

Eligibility criteria

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

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

Secondary exclusion criteria:

\- No characterization MRI done

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 7 centers
  • Groupe Hospitalier Pellegrin — Bordeaux
  • CHU Rennes — Rennes
  • CHU de Rouen — Rouen
  • Hôpital Pierre Paul Riquet, CHU Purpan — Toulouse
  • Fondation A De Rothschild — Paris
  • Centre Hospitalier Lyon Sud — Pierre-Bénite
  • Hôpital Laennec — Saint-Herblain

Identifiers

NCT: NCT04285125 · ALR_2019_16

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗