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Multimodal Connectome Study of Brain Tumor-operated Patients (ConnecTC)

Primary Purpose

Tumor, Brain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dMRI, fMRI and electrocorticography
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tumor, Brain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients with brain tumor for removal
  • Age > 18 years
  • Informed patient consent
  • Membership of social security scheme

Exclusion Criteria:

  • Contraindication to MRI
  • Any subject with vascular stent implanted less than 6 weeks prior to the exam;
  • Any subject carrying an intraocular or intracranial ferromagnetic foreign object close to nerve structures;
  • Any subject carrying biomedical equipment such as a cardiac, neuronal or sensory pacemaker (cochlear implant) or a ventricular bypass valve without medical and paramedical supervision trained in the performance of MRI in these subjects;
  • Presence of more than one brain tumor
  • Refusal of patient participation
  • Pregnant or nursing women. A urinary pregnancy test will be conducted for women of childbearing age. The results will be communicated to the patient by a doctor of her choice.
  • Person staying in a health or social establishment
  • Person in emergency situation
  • Vulnerable patient: deprived of liberty, guardianship, curators, or safeguarding of justice

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    dMRI, fMRI and electrocorticography

    Arm Description

    With this exploratory pilot study, the investigator propose a multimodal evaluation of the structural and functional connectivity of patients with brain tumours, in order to better understand the tumor-induced lesion mechanisms on brain connectivity as well as the brain plasticity mechanisms that the brain develops to maintain a level of overall function neurological. The investigator hope to obtain multimodal brain mapping of locally brain-damaged patients, with a view to improving onco-functional neurosurgical practices.

    Outcomes

    Primary Outcome Measures

    Correlations between tumor topography, cortical electrical conduction rates measured in electrocorticography, and microstructural measurements of white substance from diffusion MRI

    Secondary Outcome Measures

    Correlations between neurological disorders, tumor topography and network disruption identified in functional rest MRI

    Full Information

    First Posted
    November 12, 2019
    Last Updated
    November 13, 2019
    Sponsor
    Centre Hospitalier Universitaire de Nice
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04163315
    Brief Title
    Multimodal Connectome Study of Brain Tumor-operated Patients
    Acronym
    ConnecTC
    Official Title
    Multimodal Connectome Study of Brain Tumor-operated Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2019 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    July 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Nice

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this pilot study, the investigators propose a multimodal evaluation of the brain connectivity of brain tumor patients, in order to better understand the effects induced by focal lesions on brain structure and function, as well as brain plasticity mechanisms that may occur in such condition. The investigators aim at drawing a multimodal brain connectivity map of focally brain-damaged patients, with a view to improve onco-functional neurosurgical practices.
    Detailed Description
    Patients included in the present study will first perform the pre-operative MRI (dMRI and fMRI) with a specific High Resolution Angular Diffusion (HARDI) sequence and a functional acquisition at rest. Then, the investigators will record their cortico-cortical evoked potentials elicited by direct electrostimulation during the surgery, just before the tumor removal, following our usual protocol. Finally, all data (clinical, diffusion, electrical and functional connectivity) will be processed and correlated to each other.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tumor, Brain

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    dMRI, fMRI and electrocorticography
    Arm Type
    Experimental
    Arm Description
    With this exploratory pilot study, the investigator propose a multimodal evaluation of the structural and functional connectivity of patients with brain tumours, in order to better understand the tumor-induced lesion mechanisms on brain connectivity as well as the brain plasticity mechanisms that the brain develops to maintain a level of overall function neurological. The investigator hope to obtain multimodal brain mapping of locally brain-damaged patients, with a view to improving onco-functional neurosurgical practices.
    Intervention Type
    Other
    Intervention Name(s)
    dMRI, fMRI and electrocorticography
    Intervention Description
    Patients included in the study will perform the pre-operative MRI (fMRI and fMRI) with a specific High Resolution Angular Diffusion (HARDI) sequence and a functional rest sequence. The additional scan time for this specific sequence is approximately 25 minutes, with no foreseeable negative impact on the patient
    Primary Outcome Measure Information:
    Title
    Correlations between tumor topography, cortical electrical conduction rates measured in electrocorticography, and microstructural measurements of white substance from diffusion MRI
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Correlations between neurological disorders, tumor topography and network disruption identified in functional rest MRI
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients with brain tumor for removal Age > 18 years Informed patient consent Membership of social security scheme Exclusion Criteria: Contraindication to MRI Any subject with vascular stent implanted less than 6 weeks prior to the exam; Any subject carrying an intraocular or intracranial ferromagnetic foreign object close to nerve structures; Any subject carrying biomedical equipment such as a cardiac, neuronal or sensory pacemaker (cochlear implant) or a ventricular bypass valve without medical and paramedical supervision trained in the performance of MRI in these subjects; Presence of more than one brain tumor Refusal of patient participation Pregnant or nursing women. A urinary pregnancy test will be conducted for women of childbearing age. The results will be communicated to the patient by a doctor of her choice. Person staying in a health or social establishment Person in emergency situation Vulnerable patient: deprived of liberty, guardianship, curators, or safeguarding of justice
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fabien ALMAIRAC, MD, PhD
    Phone
    04 92 03 85 57
    Email
    almairac.f@chu-nice.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fabien ALMAIRAC, MD, PhD
    Organizational Affiliation
    Centre Hospitalier Universitaire de Nice
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23528922
    Citation
    Sporns O. The human connectome: origins and challenges. Neuroimage. 2013 Oct 15;80:53-61. doi: 10.1016/j.neuroimage.2013.03.023. Epub 2013 Mar 23.
    Results Reference
    background
    PubMed Identifier
    25848923
    Citation
    Duffau H. Stimulation mapping of white matter tracts to study brain functional connectivity. Nat Rev Neurol. 2015 May;11(5):255-65. doi: 10.1038/nrneurol.2015.51. Epub 2015 Apr 7.
    Results Reference
    background
    PubMed Identifier
    24185018
    Citation
    Yeo BT, Krienen FM, Chee MW, Buckner RL. Estimates of segregation and overlap of functional connectivity networks in the human cerebral cortex. Neuroimage. 2014 Mar;88:212-27. doi: 10.1016/j.neuroimage.2013.10.046. Epub 2013 Nov 1.
    Results Reference
    background
    PubMed Identifier
    15269116
    Citation
    Matsumoto R, Nair DR, LaPresto E, Najm I, Bingaman W, Shibasaki H, Luders HO. Functional connectivity in the human language system: a cortico-cortical evoked potential study. Brain. 2004 Oct;127(Pt 10):2316-30. doi: 10.1093/brain/awh246. Epub 2004 Jul 21.
    Results Reference
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    Multimodal Connectome Study of Brain Tumor-operated Patients

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