High Resolution Imaging for Analysis of MVNT

Recruiting

• Conditions: Benign Neuronal Desease

• Registration Number: NCT04285125
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-26
• Study Start: 2020-03-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-11
• Primary Completion: 2028-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the proportion of patients with a central T2 / FLAIR hyposignal visible on standard sequences and on ultra-high resolution sequences.	Day 1	Among the patients with confirmation of the diagnosis of MVNT (Multinodular and Vacuolating Neuronal Tumor) on the characterization MRI

Trial Locations

Locations (7)

Groupe Hospitalier Pellegrin; 🇫🇷 Bordeaux, France

Fondation A De Rothschild; 🇫🇷 Paris, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Bénite, France

CHU Rennes; 🇫🇷 Rennes, France

CHU de Rouen; 🇫🇷 Rouen, France

Hôpital Pierre Paul Riquet, CHU Purpan; 🇫🇷 Toulouse, France

Hôpital Laennec; 🇫🇷 Saint-Herblain, France