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

Primary Purpose

Brain Mass, Glioma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional Magnetic Resonance Imaging
Magnetic Resonance Imaging
Resting State Functional Connectivity Magnetic Resonance Imaging
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Mass

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (fMRI, CVR MRI, rs-fMRI)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 23, 2019
Last Updated
April 11, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03964909
Brief Title
Resting-State Functional MRI in Glioma Patients Before and After Surgery
Official Title
Resting-State Functional MRI in Glioma Patients Before and After Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Mass, Glioma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (fMRI, CVR MRI, rs-fMRI)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Functional Magnetic Resonance Imaging
Other Intervention Name(s)
fMRI, Functional MRI
Intervention Description
Undergo fMRI
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo CVR MRI
Intervention Type
Procedure
Intervention Name(s)
Resting State Functional Connectivity Magnetic Resonance Imaging
Other Intervention Name(s)
Resting fcMRI, Resting State Functional Connectivity MRI, RS-fcMRI
Intervention Description
Undergo rs-fMRI
Primary Outcome Measure Information:
Title
Detectability of language networks
Description
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.
Time Frame
Up to 6 weeks
Secondary Outcome Measure Information:
Title
Changes in resting-state functional connectivity and neuropsychological outcomes
Description
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.
Time Frame
Up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho-Ling A Liu
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho-Ling A. Liu
Phone
713-563-7383
Email
hlaliu@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Ho-Ling A. Liu

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

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

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