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Completed

NCT Number: NCT03964909

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

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.

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Key information

Conditions

Brain Mass Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

PRIMARY OBJECTIVES:

I. 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:

I. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with newly diagnosed brain mass suspected to be gliomas
  • 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 are 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
  • Pregnant women

Exclusion criteria

  • Patients with prior radiation or chemotherapy
  • Patients cannot give informed consent
  • Patients cannot undergo MRI and functional MRI examinations

Treatment and study plan

functional magnetic resonance imaging

Procedure

Undergo fMRI

Other names: fMRI, Functional MRI

Magnetic Resonance Imaging

Procedure

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

Resting State Functional Connectivity Magnetic Resonance Imaging

Procedure

Undergo rs-fMRI

Other names: Resting fcMRI, Resting State Functional Connectivity MRI, RS-fcMRI

Primary outcomes

  1. Detectability of language networks

    Time frame: 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 outcomes

  1. Changes in resting-state functional connectivity and neuropsychological outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
May 28, 2019
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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