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

NCT03964909 | Completed

• 2 other identifiers: 2016-0906NCI-2019-02653
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Mass; Glioma

Outcome Measures

Primary Outcomes (1)

• Detectability of language networks

  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.

  Up to 6 weeks

Secondary Outcomes (1)

• Changes in resting-state functional connectivity and neuropsychological outcomes

  Up to 6 weeks

Study Arms (1)

Diagnostic (fMRI, CVR MRI, rs-fMRI)

EXPERIMENTAL

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; Procedure: Magnetic Resonance Imaging; Procedure: Resting State Functional Connectivity Magnetic Resonance Imaging

Interventions

Functional Magnetic Resonance Imaging PROCEDURE

Undergo fMRI

Also known as: fMRI, Functional MRI

Diagnostic (fMRI, CVR MRI, rs-fMRI)

Magnetic Resonance Imaging PROCEDURE

Undergo CVR MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Diagnostic (fMRI, CVR MRI, rs-fMRI)

Resting State Functional Connectivity Magnetic Resonance Imaging PROCEDURE

Undergo rs-fMRI

Also known as: Resting fcMRI, Resting State Functional Connectivity MRI, RS-fcMRI

Diagnostic (fMRI, CVR MRI, rs-fMRI)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Glioma

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Ho-Ling A Liu

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: April 24, 2017
• Primary Completion: November 12, 2024
• Study Completion: November 12, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

US (1)