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High Resolution Imaging for Analysis of MVNT (HAM)

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ClinicalTrials.gov Identifier: NCT04285125
Recruitment Status : Recruiting
First Posted : February 26, 2020
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Benign Neuronal Desease Other: cerebral MRI

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Study Type : Observational
Estimated 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 : March 5, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2025

Intervention Details:
  • Other: cerebral MRI
    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


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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspicion of MVNT during a first exploratory MRI.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04285125


Contacts
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Contact: Amelie YAVCHITZ, PhD 0148036454 ayavchitz@for.paris
Contact: Augustin Lecler 0148036401 alecler@for.paris

Locations
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France
Groupe Hospitalier Pellegrin Active, not recruiting
Bordeaux, France, 33076
Fondation A De Rothschild Recruiting
Paris, France, 75019
Contact: Augustin Lecler       alecler@for.paris   
Centre Hospitalier Lyon Sud Active, not recruiting
Pierre Bénite, France, 69495
CHU Rennes Recruiting
Rennes, France, 35033
Contact: Béatrice Carsin-Nicol, MD PhD       Beatrice.CARSIN.NICOL@chu-rennes.fr   
CHU de Rouen Active, not recruiting
Rouen, France, 76000
Hôpital Laennec Recruiting
Saint-Herblain, France, 44800
Contact: Jesus AGUILLAR, MD PhD       elisabeth.calvier@chu-nantes.fr   
Hôpital Pierre Paul Riquet, CHU Purpan Active, not recruiting
Toulouse, France, 31059
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT04285125    
Other Study ID Numbers: ALR_2019_16
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No