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

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03964909
• Other study ID #: 2016-0906
• Secondary ID: NCI-2019-0265320
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2017
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Mass
• Glioma

Intervention

Procedure:
• Functional Magnetic Resonance Imaging
Undergo fMRI
• Magnetic Resonance Imaging
Undergo CVR MRI
• Resting State Functional Connectivity Magnetic Resonance Imaging
Undergo rs-fMRI

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in resting-state functional connectivity and neuropsychological outcomes	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.	Up to 6 weeks

External Links

•   MD Anderson Cancer Center Website