High Resolution Imaging for Analysis of MVNT

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04285125
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fondation Ophtalmologique Adolphe de Rothschild
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Benign Neuronal Desease

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Groupe Hospitalier Pellegrin, Bordeaux, France

Status

Active, not recruiting

Address

Groupe Hospitalier Pellegrin

Bordeaux, , 33076

Fondation A De Rothschild, Paris, France

Status

Recruiting

Address

Fondation A De Rothschild

Paris, , 75019

Site Contact

Augustin Lecler

[email protected]

0148036454

Centre Hospitalier Lyon Sud, Pierre Bénite, France

Status

Active, not recruiting

Address

Centre Hospitalier Lyon Sud

Pierre Bénite, , 69495

CHU Rennes, Rennes, France

Status

Recruiting

Address

CHU Rennes

Rennes, , 35033

Site Contact

Béatrice Carsin-Nicol, MD PhD

[email protected]

0148036454

CHU de Rouen, Rouen, France

Status

Active, not recruiting

Address

CHU de Rouen

Rouen, , 76000

Hôpital Laennec, Saint-Herblain, France

Status

Recruiting

Address

Hôpital Laennec

Saint-Herblain, , 44800

Site Contact

Jesus AGUILLAR, MD PhD

[email protected]

0148036454

Hôpital Pierre Paul Riquet, CHU Purpan, Toulouse, France

Status

Active, not recruiting

Address

Hôpital Pierre Paul Riquet, CHU Purpan

Toulouse, , 31059

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