High Resolution Imaging for Analysis of MVNT

NCT04285125 | Recruiting

• 1 other identifier: ALR_2019_16
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 7

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.

Conditions

Benign Neuronal Desease

Outcome Measures

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

  Day 1

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspicion of MVNT during a first exploratory MRI.

You may qualify if:

• Patient over 18 years of age
• 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

You may not qualify if:

• Contraindication to MRI
• Patient benefiting from a legal protection measure
• Pregnant or breastfeeding woman
• \- No characterization MRI done

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (7)

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

Central Study Contacts

Amelie YAVCHITZ, PhD

CONTACT

0148036454; ayavchitz@for.paris

Augustin Lecler

CONTACT

0148036401; alecler@for.paris

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: February 26, 2020
• Study Start: March 5, 2020
• Primary Completion: May 19, 2025
• Study Completion (Estimated): May 19, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)