xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06040580</url>
    </required_header>
    <id_info>
      <org_study_id>S61759</org_study_id>
      <nct_id>NCT06040580</nct_id>
    </id_info>
    <brief_title>Can we Use Resting-state fMRI and CSD Fiber Tractography for Presurgical Mapping?</brief_title>
    <official_title>The Use of Resting State fMRI and CSD Tractography for Pre-operative Brain Mapping: a Cross-sectional Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitaire Ziekenhuizen KU Leuven</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitaire Ziekenhuizen KU Leuven</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This prospective study aims to investigate and validate the use of resting-state functional&#xD;
        MRI (rs-fMRI) and high angular resolution diffusion imaging (HARDI), specifically constrained&#xD;
        spherical deconvolution (CSD) tractography, for functional and structural brain mapping prior&#xD;
        to neurosurgery. The goal is to assess the feasibility of replacing task-based fMRI (tb-fMRI)&#xD;
        and diffusion tensor imaging (DTI) with fiber tractography (FT) using the fiber assignment by&#xD;
        continuous tracking (FACT) algorithm. The study focuses on mapping sensory-motor, language,&#xD;
        visual, and higher cognitive functional and structural networks in patients with brain&#xD;
        pathology suitable for surgical intervention. The objective is to improve neurosurgical&#xD;
        planning, navigation, and risk assessment through the utilization of rs-fMRI and CSD&#xD;
        tractography.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study aims to prospectively investigate and validate the application of resting state&#xD;
        functional MRI (rs-fMRI) and High angular resolution diffusion imaging (HARDI), particularly&#xD;
        constrained spherical deconvolution (CSD) tractography, in presurgical functional and&#xD;
        structural brain mapping for the purposes of neurosurgical planning, navigation and risk&#xD;
        assessment. The main objective is to determine whether rs-fMRI and CSD tractography are&#xD;
        capable of replacing task based fMRI (tb-fMRI) and diffusion tensor imaging (DTI) based fiber&#xD;
        tractography (FT) using the fiber assignment by continuous tracking (FACT) algorithm for&#xD;
        mapping the sensory-motor, language, visual, as well as higher cognitive functional and&#xD;
        structural networks of the brain in patients with brain pathology amenable for surgical&#xD;
        intervention. This research question will be investigated by acquiring tb-fMRI and rs-fMRI,&#xD;
        as well as HARDI data for presurgical patients. The routine workflow of presurgical planning&#xD;
        and risk assessment using tb-fMRI and DTI FT will be followed and used for the initial&#xD;
        planning. Previous studies have revealed a high degree of concordance between rs-fMRI and&#xD;
        tb-fMRI[1]-[5] as well as between CSD and DTI FT[6]-[8], but drew such conclusions from&#xD;
        relatively small sample sizes. The aim is to incorporate the rs-fMRI and CSD results into the&#xD;
        presurgical planning process albeit with more weight assigned to the tb-fMRI and DTI results.&#xD;
        The study population will consist of 10 normal controls for MR imaging optimization purposes&#xD;
        only, 150 presurgical patients from the UZ Leuven imaging department regardless of the exact&#xD;
        type of pathology (space occupying lesions, epilepsy, vascular malformations etc.).&#xD;
  &#xD;
        As tb-fMRI has previously been validated versus the gold standard of functional mapping,&#xD;
        electrical cortical stimulation (ECS), while rs-fMRI has previously been validated against&#xD;
        tb-fMRI. The same has been done comparing DTI and CSD. To our knowledge however, a&#xD;
        comparative study with such a large and diverse study population attempting to cross validate&#xD;
        all these modalities against the gold standard has not yet been done.&#xD;
  &#xD;
        Image acquisition acceleration methods, such as parallel imaging (PI), simultaneous&#xD;
        multislice acquisitions (SMS) and compressed sensing (CS) will be used whenever feasible.&#xD;
        These acceleration methods can potentially be exploited to improve fMRI, and dMRI data&#xD;
        quality as well as shorten acquisition time. In the case of fMRI, PI and SMS can be used to&#xD;
        increase temporal resolution, temporal signal to noise ratio and even spatial resolution.&#xD;
        dMRI stands to benefit from such techniques by increasing directional and/or spatial&#xD;
        resolution.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">October 8, 2018</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Differences in accuracy between CSD and DTI fiber tractography as well as resting-state and task-based fMRI</measure>
      <time_frame>Through phase 1 recruitment completion (about 2 years from start of recruitment)</time_frame>
      <description>A comparative analysis examining differences in accuracy measures between different fMRI and dMRI tractography methods, namely resting-state fMRI v. task-based fMRI and DTI v CSD diffusion tractography using intraoperative direct electrical stimulation results as the ground truth</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Brain Tumor</condition>
    <condition>Brain Pathology</condition>
    <condition>Epilepsy</condition>
    <condition>Vascular Malformations, Brain</condition>
    <arm_group>
      <arm_group_label>Patients</arm_group_label>
      <description>Preoperative patients in need of brain surgery for varying brain pathology who require presurgical brain mapping with MRI (fMRI, and dMRI)</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with any brain pathology amenable to surgery who have not undergone previous&#xD;
          resective surgery, regardless of age, gender or type of disease.&#xD;
  &#xD;
          Healthy volunteers are only included for scan optimization puproses.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Stable clinical condition&#xD;
  &#xD;
            -  Cooperative and able to perform the fMRI tasks in question&#xD;
  &#xD;
            -  In need of preoperative MRI mapping scans&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Absolute contraindications to MRI&#xD;
  &#xD;
            -  Previously underwent resective brain surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>UZ Leuven</name>
        <address>
          <city>Leuven</city>
          <state>Vlaams Brabant</state>
          <zip>3000</zip>
          <country>Belgium</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <reference>
      <citation>Radwan AM, Sunaert S, Schilling K, Descoteaux M, Landman BA, Vandenbulcke M, Theys T, Dupont P, Emsell L. An atlas of white matter anatomy, its variability, and reproducibility based on constrained spherical deconvolution of diffusion MRI. Neuroimage. 2022 Jul 1;254:119029. doi: 10.1016/j.neuroimage.2022.119029. Epub 2022 Feb 26.</citation>
      <PMID>35231632</PMID>
    </reference>
    <results_reference>
      <citation>Radwan AM, Emsell L, Blommaert J, Zhylka A, Kovacs S, Theys T, Sollmann N, Dupont P, Sunaert S. Virtual brain grafting: Enabling whole brain parcellation in the presence of large lesions. Neuroimage. 2021 Apr 1;229:117731. doi: 10.1016/j.neuroimage.2021.117731. Epub 2021 Jan 14.</citation>
      <PMID>33454411</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universitaire Ziekenhuizen KU Leuven</investigator_affiliation>
      <investigator_full_name>Prof dr Stefan Sunaert</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Functional MRI</keyword>
    <keyword>Diffusion MRI</keyword>
    <keyword>Fiber Tractography</keyword>
    <keyword>Preoperative brain mapping</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Central Nervous System Vascular Malformations</mesh_term>
      <mesh_term>Vascular Malformations</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Anonymized and coded data may be shared with other research groups upon reasonable request to the authors.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06040580
  org study id: S61759
  nct id: NCT06040580
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This prospective study aims to investigate and validate the use of resting-state functional
        MRI (rs-fMRI) and high angular resolution diffusion imaging (HARDI), specifically constrained
        spherical deconvolution (CSD) tractography, for functional and structural brain mapping prior
        to neurosurgery. The goal is to assess the feasibility of replacing task-based fMRI (tb-fMRI)
        and diffusion tensor imaging (DTI) with fiber tractography (FT) using the fiber assignment by
        continuous tracking (FACT) algorithm. The study focuses on mapping sensory-motor, language,
        visual, and higher cognitive functional and structural networks in patients with brain
        pathology suitable for surgical intervention. The objective is to improve neurosurgical
        planning, navigation, and risk assessment through the utilization of rs-fMRI and CSD
        tractography.
  This study aims to prospectively investigate and validate the application of resting state
        functional MRI (rs-fMRI) and High angular resolution diffusion imaging (HARDI), particularly
        constrained spherical deconvolution (CSD) tractography, in presurgical functional and
        structural brain mapping for the purposes of neurosurgical planning, navigation and risk
        assessment. The main objective is to determine whether rs-fMRI and CSD tractography are
        capable of replacing task based fMRI (tb-fMRI) and diffusion tensor imaging (DTI) based fiber
        tractography (FT) using the fiber assignment by continuous tracking (FACT) algorithm for
        mapping the sensory-motor, language, visual, as well as higher cognitive functional and
        structural networks of the brain in patients with brain pathology amenable for surgical
        intervention. This research question will be investigated by acquiring tb-fMRI and rs-fMRI,
        as well as HARDI data for presurgical patients. The routine workflow of presurgical planning
        and risk assessment using tb-fMRI and DTI FT will be followed and used for the initial
        planning. Previous studies have revealed a high degree of concordance between rs-fMRI and
        tb-fMRI[1]-[5] as well as between CSD and DTI FT[6]-[8], but drew such conclusions from
        relatively small sample sizes. The aim is to incorporate the rs-fMRI and CSD results into the
        presurgical planning process albeit with more weight assigned to the tb-fMRI and DTI results.
        The study population will consist of 10 normal controls for MR imaging optimization purposes
        only, 150 presurgical patients from the UZ Leuven imaging department regardless of the exact
        type of pathology (space occupying lesions, epilepsy, vascular malformations etc.).
  
        As tb-fMRI has previously been validated versus the gold standard of functional mapping,
        electrical cortical stimulation (ECS), while rs-fMRI has previously been validated against
        tb-fMRI. The same has been done comparing DTI and CSD. To our knowledge however, a
        comparative study with such a large and diverse study population attempting to cross validate
        all these modalities against the gold standard has not yet been done.
  
        Image acquisition acceleration methods, such as parallel imaging (PI), simultaneous
        multislice acquisitions (SMS) and compressed sensing (CS) will be used whenever feasible.
        These acceleration methods can potentially be exploited to improve fMRI, and dMRI data
        quality as well as shorten acquisition time. In the case of fMRI, PI and SMS can be used to
        increase temporal resolution, temporal signal to noise ratio and even spatial resolution.
        dMRI stands to benefit from such techniques by increasing directional and/or spatial
        resolution.
  observational model: Cohort
  time perspective: Prospective
  measure: Differences in accuracy between CSD and DTI fiber tractography as well as resting-state and task-based fMRI
  time frame: Through phase 1 recruitment completion (about 2 years from start of recruitment)
  description: A comparative analysis examining differences in accuracy measures between different fMRI and dMRI tractography methods, namely resting-state fMRI v. task-based fMRI and DTI v CSD diffusion tractography using intraoperative direct electrical stimulation results as the ground truth
  arm group label: Patients
  description: Preoperative patients in need of brain surgery for varying brain pathology who require presurgical brain mapping with MRI (fMRI, and dMRI)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Belgium
  citation: Radwan AM, Sunaert S, Schilling K, Descoteaux M, Landman BA, Vandenbulcke M, Theys T, Dupont P, Emsell L. An atlas of white matter anatomy, its variability, and reproducibility based on constrained spherical deconvolution of diffusion MRI. Neuroimage. 2022 Jul 1;254:119029. doi: 10.1016/j.neuroimage.2022.119029. Epub 2022 Feb 26.
  PMID: 35231632
  citation: Radwan AM, Emsell L, Blommaert J, Zhylka A, Kovacs S, Theys T, Sollmann N, Dupont P, Sunaert S. Virtual brain grafting: Enabling whole brain parcellation in the presence of large lesions. Neuroimage. 2021 Apr 1;229:117731. doi: 10.1016/j.neuroimage.2021.117731. Epub 2021 Jan 14.
  PMID: 33454411
  responsible party type: Principal Investigator
  investigator affiliation: Universitaire Ziekenhuizen KU Leuven
  investigator full name: Prof dr Stefan Sunaert
  investigator title: Principal Investigator
  mesh term: Central Nervous System Vascular Malformations
  mesh term: Vascular Malformations
  sharing ipd: No
  ipd description: Anonymized and coded data may be shared with other research groups upon reasonable request to the authors.