NCT04103190

Brief Summary

Differential diagnoses of MVNT include DNT (dysembryoplastic neuroepithelial tumor), low-grade gliomas, cortical dysplasias or even hamartomas.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 10, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2025

Completed
Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

3.6 years

First QC Date

June 21, 2019

Last Update Submit

December 30, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Description of a new radiological entity on Spectroscopy : the MVNT (Multinodular and Vacuolating Neuronal Tumor)

    ratio of N-Acetylaspartate / Choline on Spectroscopy

    1 day

  • Description of a new radiological entity on Spectroscopy : the MVNT (Multinodular and Vacuolating Neuronal Tumor)

    area under curve of the N-Acetylaspartate Spectroscopie

    1 day

  • Description of a new radiological entity on Spectroscopy : : the MVNT (Multinodular and Vacuolating Neuronal Tumor)

    area under curve of choline Spectroscopie

    1 day

Interventions

Patients who agree to participate in the study will perform a 3T multi-parametric MRI with advanced spectroscopic imaging techniques and standard protocol. A neurological consultation will take place during the inclusion visit as well as a questionnaire and a control MRI at 1 year and 2 years +/- 1 month.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient supported for suspicion of MVNT

You may qualify if:

  • Patient over 18 years old
  • Suspicion of MVNT on an MRI: it is considered that it will be necessary at least the 2 major criteria associated with at least 1 minor criterion to enter the definition of suspicion of MVNT:
  • Major criteria:
  • Multinodular aspect in cluster
  • High FLAIR hypersignal / T2
  • Minor criteria:
  • Absence of mass effect
  • Hyposignal T1
  • Center of the lesion in hypsignal FLAIR or T1 hypersignal
  • Affiliate or beneficiary of a Social Security scheme
  • Having received informed information about the study and consenting to participate in the study

You may not qualify if:

  • Patient benefiting from a legal protection measure
  • Pregnant or lactating woman
  • Contraindication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Groupe Hospitalier Pellegrin

Bordeaux, Bordeaux, 33076, France

Location

Fondation Adolphe de Rothschild

Paris, PARIS, 75019, France

Location

CHU Rennes

Rennes, Rennes, 35033, France

Location

CHU de Rouen

Rouen, Rouen, 76000, France

Location

Hôpital Pierre Paul Riquet, CHU Purpan

Toulouse, Toulouse, 31059, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Hôpital Laennec

Saint-Herblain, 44800, France

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2019

First Posted

September 25, 2019

Study Start

December 10, 2019

Primary Completion

July 10, 2023

Study Completion

July 10, 2025

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations