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In Vivo and ex Vivo Validation of MR Tractography of Brain White Matter Tracts - FIBRATLAS II-III (FIBRATLAS)

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ClinicalTrials.gov Identifier: NCT02455284
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief Summary:

White matter tracts connect cortical areas to other parts of the cortex, to basal ganglia and to the brain stem and spinal cord. These tracts form the internal part of the brain and transmit the nervous impulses. Changes in brain white matter may serve as biomarkers for numerous neurological diseases.

Diffusion Weighted Imaging (DWI) is a non-invasive MRI (Magnetic Resonance Imaging) technique providing information on white matter tracts (tractography) by studying water diffusion. Since it is based on complex mathematical models that only indirectly evaluates the underlying anatomy, tractography need to be validated before being used for research and clinical purposes. Several validation techniques were previously proposed, none of them being fully convincing in human.


Condition or disease Intervention/treatment Phase
Neurological Diseases Device: MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: In Vivo and ex Vivo Validation of MR Tractography of Brain White Matter Tracts - FIBRATLAS II-III
Study Start Date : October 2015
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy subjects
MRI and neuropsychological evaluation
Device: MRI
In vivo MRI with B0 cartography, FLAIR, 3D T1 anatomic images, DWI, and Tractography from DWI images




Primary Outcome Measures :
  1. Reconstructions of the fiber tracts [ Time Frame: 5.5 years ]
    similarity indices, such as modified Haussdorf distance, measured on MRI images


Secondary Outcome Measures :
  1. Number of subjects included in the database [ Time Frame: 5.5 years ]
    Number of subjects included in the database

  2. Scores at neuropsychological evaluation [ Time Frame: 5.5 years ]
    Scores at neuropsychological evaluation

  3. In vivo MRI measures obtained from DWI [ Time Frame: 5.5 years ]
    In vivo MRI measures obtained from DWI



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Ages Eligible for Study:   82 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Prior enrollment in a body donation program
  • Age ≥ 82 years
  • Absence of major cognitive impairment as demonstrated by independent living skills in 4 fields evaluated by the IADL (4 items) (Lawton and Brody, 1969)
  • Distance to one of the participating laboratories ≤ 120km
  • Able to remain supine in the MR scanner for acquisition duration (60 min),
  • Affiliation to Social Security
  • Informed and written consent

Non Inclusion Criteria:

  • Past or present Neurological or Neurosurgical diseases (excluding trauma or degenerative spinal lesions)
  • Uncontrolled: High blood pressure, diabetes (types I or II), or dyslipemia
  • Contraindications to MRI
  • Contraindication to body donation

Exclusion criteria

  • Diagnosis on MRI of brain lesions, excepted common age-related changes

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): NCT02455284


Contacts
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Contact: Christophe DESTRIEUX, PhD +33247366136 christophe.destrieux@univ-tours.fr
Contact: Catherine Roussel +33247479789 roussel@med.univ-tours.fr

Locations
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France
University Hospital of Amiens Recruiting
Amiens, France, 80054
Contact: Johan Peltier, PhD    +33 3 22 66 83 40    Peltier.Johann@chu-amiens.fr   
Contact: Jean-Marc Constans, PhD    +33 3 22 08 75 11    constans.jean-marc@chu-amiens.fr   
Principal Investigator: Johan PELTIER, PhD         
Sub-Investigator: Jean-Marc CONSTANS, PhD         
Sub-Investigator: Olivier GODEFROY, PhD         
Sub-Investigator: Sandrine SORIOT-THOMAS, MD         
University Hospital of Angers Recruiting
Angers, France, 49033
Contact: Mathieu Delion, MD       Matthieu.Delion@chu-angers.fr   
Contact: Philippe Mercier, PhD    +33 2 41 73 58 21    philippe.mercier@univ-angers.fr   
Principal Investigator: Mathieu DELION, MD         
Sub-Investigator: Philippe MERCIER, PhD         
Sub-Investigator: Anna PASCO-PAPON, MD         
Sub-Investigator: Marc-Antoine CUSTAUD, PhD         
University Hospital of Brest Recruiting
Brest, France, 29609
Contact: Romuald Seizeur, PhD    +33 2 98 34 73 27    romuald.seizeur@chu-brest.fr   
Contact: Douraied Ben Salem, PhD    +33 2 98 34 75 20    douraied.bensalem@chu-brest.fr   
Principal Investigator: Romuald SEIZEUR, PhD         
Sub-Investigator: Douraied BEN SALEM, PhD         
Sub-Investigator: Karine LACUT, PhD         
Hospital of Charpennes - Lyon Recruiting
Lyon, France, 69000
Contact: Emile SIMON, MD    0427856944    emile.simon@chu-lyon.fr   
Principal Investigator: Emile SIMON, MD         
Sub-Investigator: Jing XIE, MD         
University Hospital of Nancy Recruiting
Nancy, France, 54511
Contact: Marc Braun, PhD    +33 3 83 85 95 27    marc.braun@univ-lorraine.fr   
Contact: Romain Tonnelet, MD    +33 3 83 85 16 18    r.tonnelet@chu-nancy.fr   
Principal Investigator: Marc BRAUN, PhD         
Sub-Investigator: Romain TONNELET, MD         
University Hospital of Rennes Not yet recruiting
Rennes, France, 35033
Contact: Xavier Morandi, PhD       xavier.morandi@chu-rennes.fr   
Contact: Jean-Christophe Ferre, PhD    +33 2 99 28 92 42    Jean-christophe.FERRE@chu-rennes.fr   
Principal Investigator: Xavier MORANDI, PhD         
Sub-Investigator: Jean-Christophe FERRE, PhD         
Sub-Investigator: Fabrice LAINE, MD         
University Hospital of Tours Recruiting
Tours, France, 37044
Contact: Christophe Destrieux, PhD    +33 2 47 36 61 36    christophe.destrieux@univ-tours.fr   
Contact: Katia Desplobain    +33 2 18 37 08 03    k.chene@chu-tours.fr   
Principal Investigator: Christophe DESTRIEUX, PhD         
Sub-Investigator: Valerie GISSOT, MD         
Sub-Investigator: Stephane VELUT, PhD         
Sub-Investigator: Ilyess ZEMMOURA, MD         
Sub-Investigator: Jean-Philippe COTTIER, PhD         
Sub-Investigator: Caroline HOMMET, PhD         
Sub-Investigator: Karl MONDON, MD         
Sponsors and Collaborators
University Hospital, Tours
Investigators
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Principal Investigator: Christophe DESTRIEUX, PhD University Hospital of Tours

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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT02455284     History of Changes
Other Study ID Numbers: ANR 14 - CD / FIBRATLAS
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: May 2019

Keywords provided by University Hospital, Tours:
MRI
Tractography
white
physiology
analysis
matter
tracts

Additional relevant MeSH terms:
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Nervous System Diseases