Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multiparametric Imaging for Analysis of MVNT (Multinodular and Vacuolating Neuronal Tumor) (MIAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04103190
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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

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

Detailed Description:

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

However, in order to avoid an invasive surgical procedure to remove the lesion, a certain diagnosis of its benignity is essential. The contribution of advanced techniques in MRI, such as spectroscopy in the characterization of these lesions, has not yet been studied today

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Multiparametric Imaging for Analysis of MVNT (Multinodular and Vacuolating Neuronal Tumor)
Actual Study Start Date : December 10, 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2026

Intervention Details:
  • Device: cerebral MRI

    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.



Primary Outcome Measures :
  1. Description of a new radiological entity on Spectroscopy : the MVNT (Multinodular and Vacuolating Neuronal Tumor) [ Time Frame: 1 day ]
    ratio of N-Acetylaspartate / Choline on Spectroscopy

  2. Description of a new radiological entity on Spectroscopy : the MVNT (Multinodular and Vacuolating Neuronal Tumor) [ Time Frame: 1 day ]
    area under curve of the N-Acetylaspartate Spectroscopie

  3. Description of a new radiological entity on Spectroscopy : : the MVNT (Multinodular and Vacuolating Neuronal Tumor) [ Time Frame: 1 day ]
    area under curve of choline Spectroscopie



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient supported for suspicion of MVNT
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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): NCT04103190


Contacts
Layout table for location contacts
Contact: Laurence Salomon, MD PhD 0148036431 ext +33 lsalomon@for.paris
Contact: Augustin Lecler, MD PhD 0418036401 alecler@for.paris

Locations
Layout table for location information
France
Groupe Hospitalier Pellegrin Not yet recruiting
Bordeaux, France, 33076
Contact: Thomas Touridas, MD PhD       thomas.tourdias@chu-bordeaux.fr   
Fondation Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Augustin Lecler, PhD       alecler@for.paris   
Centre Hospitalier Lyon Sud Not yet recruiting
Pierre Bénite, France, 69495
Contact: François Cotton, MD PhD       francois.cotton@chu-lyon.fr   
CHU Rennes Not yet recruiting
Rennes, France, 35033
Contact: Béatrice Carsin-Nicol, MD PhD       Beatrice.CARSIN.NICOL@chu-rennes.fr   
CHU de Rouen Not yet recruiting
Rouen, France, 76000
Contact: Emmanue Gerardin, MD PhD       Emmanuel.Gerardin@chu-rouen.fr   
Hôpital Laennec Not yet recruiting
Saint-Herblain, France, 44800
Contact: Jesus AGUILLAR, MD PhD       elisabeth.calvier@chu-nantes.fr   
Hôpital Pierre Paul Riquet, CHU Purpan Not yet recruiting
Toulouse, France, 31059
Contact: Fabrice BONNEVILLE, MD PhD       bonneville.f@chu-toulouse.fr   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild

Layout table for additonal information
Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT04103190    
Other Study ID Numbers: ALR_2019_4
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No