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A Comprehensive Clinical fMRI Software Solution to Enable Mapping of Critical Functional Networks and Cerebrovascular Reactivity in the Brain

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05342454
Collaborator
(none)
1,720
Enrollment
1
Location
54
Anticipated Duration (Months)
31.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Our preliminary work demonstrates that an integrated fMRI software solution, incorporating tb-fMRI, rs-fMRI, and CVR mapping, is clinically feasible and helps clinicians plan brain tumor resection. We have developed a novel automated seed selection method that can accurately map language networks from rs-fMRI. We hypothesize that our innovative approach to enhance, optimize, and validate our preliminary software and integrate it with an established fMRI platform will create robust solutions for clinical RSN and CVR mapping. Partnering with NordicNeuroLab (NNL) will leverage the professional software development by a seasoned commercial MRI software producer in coordination with leading clinical and research experts at MD Anderson. The research will be conducted through three specific aims:

  1. Develop a clinical software platform for mapping RSNs and determine optimized workflow for presurgical localization of eloquent areas.

  2. Develop a clinical software platform for mapping CVR and determine optimized workflow for identifying and visualizing brain areas with potential false-negative fMRI results.

  3. Test and validate RSN and CVR mapping software in patients undergoing neurosurgery.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Primary Objectives:

    To validate resting-state fMRI (rs-fMRI) mapping of language and motor (hand and tongue) areas obtained by using the software developed in this research: We will test the non-inferiority of rs-fMRI comparing to task-based fMRI (tb-fMRI) by using intra-operative direct cortical stimulation as the gold standard.

    To test whether CVR mapping using the software developed in this research will increase confidence of fMRI mapping of language and motor (hand and tongue) areas: We will test whether the accuracy of fMRI, assessed by using intra-operative direct cortical stimulation as the gold standard, will improve after incorporating the CVR mapping.

    Secondary Objectives:

    To optimize the rs-fMRI and CVR mapping software during the development phases and to test feasibility of the post-processing workflow using clinical images.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1720 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Other
    Official Title:
    A Comprehensive Clinical fMRI Software Solution to Enable Mapping of Critical Functional Networks and Cerebrovascular Reactivity in the Brain
    Anticipated Study Start Date :
    May 30, 2022
    Anticipated Primary Completion Date :
    Nov 30, 2026
    Anticipated Study Completion Date :
    Nov 30, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Validate resting-state fMRI (rs-fMRI) mapping of language and motor (hand and tongue) areas obtained by using the software developed in this research. [Through study completion, an average of 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    1. patient must be >/= 18 years of age;

    2. patients who will undergo neurosurgical resection of brain tumors;

    3. patients who will undergo presurgical fMRI as standard of care;

    4. patients who on neurosurgical evaluation will undergo direct cortical stimulation (DCS) as standard of care.

    For the retrospective study, we will review up to 1600 patients all clinical presurgical fMRI studies performed on brain tumor patients at the MD Anderson since 5/2004.

    The inclusion criteria:

    1. patients must be >/= 18 years of age;

    2. patients who had the presurgical fMRI that contained at least one task-based fMRI scan.

    Exclusion Criteria:
    Exclusion criteria for the prospective study:

    1. patients cannot give informed consent;

    2. patients cannot undergo MRI examinations;

    3. patients who are indicated for speech fMRI only but cannot comply with any of the speech tasks based on the evaluation of a clinical neuropsychologist.

    Exclusion criteria for the retrospective study:

    1. all fMRI scans were contaminated by head motions (translation > 2 mm or rotation > 2 degrees);

    2. only speech fMRI paradigms were performed, and patients were not able to comply with any of the speech tasks based on the evaluation of a clinical neuropsychologist.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Ho-Ling Liu, PhD, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05342454
    Other Study ID Numbers:
    • 2021-0791
    • NCI-2022-00369
    First Posted:
    Apr 22, 2022
    Last Update Posted:
    Apr 22, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Brain Neoplasms

    Study Results

    No Results Posted as of Apr 22, 2022