Resting-State Functional MRI in Glioma Patients Before and After Surgery

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03964909
Collaborator
National Cancer Institute (NCI) (NIH)
30
1
1
80.2
0.4

Study Details

Study Description

Brief Summary

This clinical trial studies how well resting-state functional magnetic resonance imaging (MRI) and cerebrovascular reactivity (CVR) MRI performed before and after surgery works in measuring the effects on language in patients with glioma. Mapping language function before brain tumor resection is crucial for preventing post-surgical deficits and maximizing restoration of language function following surgery. Additional imaging, such as resting-state functional MRI and CVR MRI, may help measure the language network in the brain before surgery and any effects on language function after surgery.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Functional Magnetic Resonance Imaging
  • Procedure: Magnetic Resonance Imaging
  • Procedure: Resting State Functional Connectivity Magnetic Resonance Imaging
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. To develop a reliable platform for preoperative mapping of language networks using resting-state-functional magnetic resonance imaging (rs)-fMRI in glioma patients.
SECONDARY OBJECTIVES:
  1. To explore the reorganizations of resting-state functional connectivity (FC) and their relation to neuropsychological outcomes in glioma patients after surgery.
OUTLINE:

Patients undergo standard of care functional (f)MRI, CVR MRI over 3 minutes, and rs-fMRI over 6 minutes 1 month before and within 6 weeks after standard of care surgery.

After completion of study, patients are followed up at 4-6 weeks.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Resting-State Functional MRI in Glioma Patients Before and After Surgery
Actual Study Start Date :
Apr 24, 2017
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnostic (fMRI, CVR MRI, rs-fMRI)

Patients undergo standard of care fMRI, CVR MRI over 3 minutes, and rs-fMRI over 6 minutes 1 month before and within 6 weeks after standard of care surgery.

Procedure: Functional Magnetic Resonance Imaging
Undergo fMRI
Other Names:
  • fMRI
  • Functional MRI
  • Procedure: Magnetic Resonance Imaging
    Undergo CVR MRI
    Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Procedure: Resting State Functional Connectivity Magnetic Resonance Imaging
    Undergo rs-fMRI
    Other Names:
  • Resting fcMRI
  • Resting State Functional Connectivity MRI
  • RS-fcMRI
  • Outcome Measures

    Primary Outcome Measures

    1. Detectability of language networks [Up to 6 weeks]

      Will be performed using resting-state-functional magnetic resonance imaging (rs-fMRI). The receiver operating characteristic (ROC) analysis will be carried out to compare the difference between the diagnostic performance of the proposed method and that of the data-driven rs-fMRI method. The study will evaluate the performance of rs-fMRI by comparing with the standard of care intraoperative direct cortical stimulation.

    Secondary Outcome Measures

    1. Changes in resting-state functional connectivity and neuropsychological outcomes [Up to 6 weeks]

      Graph theoretical analysis and large-scale network analysis will be applied to analyze pre- and post- surgical rs-fMRI data, to explore how the functional reorganization is correlated to the changes of neuropsychological scores. Correlational analyses will be conducted to determine the associations between changes in rs-fMRI network features and neuropsychological functioning from the pre- to postoperative period.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with newly diagnosed brain mass suspected to be gliomas

    • Native English speaker

    • Right handed

    • Tumor is located on or adjacent to Broca's or Wernicke's areas in the hemisphere suspected to be dominant for language

    • No prior history of neurologic disease or insult, or neuropsychiatric illness requiring treatment that would affect cognition in the opinion of the attending neuropsychologist

    • Patients who will undergo neurosurgical resection

    • Patients who on neurosurgical evaluation will undergo direct cortical stimulation (DCS) as standard of care

    • Patients who will complete pre- and postoperative neuropsychological testing per standard of care

    Exclusion Criteria:
    • Patients with prior radiation or chemotherapy

    • Patients cannot give informed consent

    • Patients cannot undergo MRI and functional MRI examinations

    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
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Ho-Ling A Liu, 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:
    NCT03964909
    Other Study ID Numbers:
    • 2016-0906
    • NCI-2019-02653
    • 2016-0906
    First Posted:
    May 28, 2019
    Last Update Posted:
    Jun 24, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 24, 2022