High Resolution Imaging for Analysis of MVNT (HAM)

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.

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 Overview

• Status: Recruiting
• Conditions: Benign Neuronal Desease
• Intervention / Treatment: Other: cerebral MRI

• Study Type: Observational
• Enrollment (Estimated): 33

Contacts and Locations

• Study Contact: Name: Amélie YAVCHITZ, PhD; Phone Number: 0148036454; Email: ayavchitz@for.paris
• Study Contact Backup: Name: Augustin Lecler; Phone Number: 0148036401; Email: alecler@for.paris

Study Locations

• France
  • Bordeaux, France, 33076
    • Active, not recruiting
    • Groupe Hospitalier Pellegrin
  • Paris, France, 75019
    • Recruiting
    • Fondation A De Rothschild
    • Contact: Augustin Lecler; Email: alecler@for.paris
  • Pierre Bénite, France, 69495
    • Active, not recruiting
    • Centre Hospitalier Lyon Sud
  • Rennes, France, 35033
    • Recruiting
    • CHU Rennes
    • Contact: Béatrice Carsin-Nicol, MD PhD; Email: Beatrice.CARSIN.NICOL@chu-rennes.fr
  • Rouen, France, 76000
    • Active, not recruiting
    • CHU de Rouen
  • Saint-Herblain, France, 44800
    • Recruiting
    • Hôpital Laënnec
    • Contact: Jesus AGUILLAR, MD PhD; Email: elisabeth.calvier@chu-nantes.fr
  • Toulouse, France, 31059
    • Active, not recruiting
    • Hôpital Pierre Paul Riquet, CHU Purpan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with suspicion of MVNT during a first exploratory MRI.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2020
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ALR_2019_16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No