HAM: High Resolution Imaging for Analysis of MVNT

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Recruiting

CT.gov ID

NCT04285125

Collaborator

(none)

Enrollment

Locations

59.9

Anticipated Duration (Months)

4.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Neuronal Desease	Other: cerebral MRI

Study Design

Study Type:

Observational

Anticipated Enrollment :

33 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 5, 2020

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2025

Outcome Measures

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. [Day 1]
Among the patients with confirmation of the diagnosis of MVNT (Multinodular and Vacuolating Neuronal Tumor) on the characterization MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Groupe Hospitalier Pellegrin	Bordeaux	France	33076
2	Fondation A De Rothschild	Paris	France	75019
3	Centre Hospitalier Lyon Sud	Pierre Bénite	France	69495
4	CHU Rennes	Rennes	France	35033
5	CHU de Rouen	Rouen	France	76000
6	Hôpital Laennec	Saint-Herblain	France	44800
7	Hôpital Pierre Paul Riquet, CHU Purpan	Toulouse	France	31059

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondation Ophtalmologique Adolphe de Rothschild

ClinicalTrials.gov Identifier:

NCT04285125

Other Study ID Numbers:

ALR_2019_16

First Posted:

Feb 26, 2020

Last Update Posted:

Mar 21, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 21, 2022