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NCT Number: NCT04285125

High Resolution Imaging for Analysis of MVNT

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.

Recruiting

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Key information

Conditions

Benign Neuronal Desease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Pellegrin, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cerebral MRI

Other

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 outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Amelie YAVCHITZ, PhD

CONTACT

[email protected]

0148036454

Augustin Lecler

CONTACT

[email protected]

0148036401

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

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

Acronym: HAM

Important dates

Study start
2020
Primary completion
2025
Study completion
2027
First posted
Feb 26, 2020
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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