fMRI Reveal Functional Preservation in Glioma Peritumoral Edema

January 6, 2026 updated by: Simin Zhang, West China Hospital

Individualized fMRI and Molecular Profiling Reveal Functional Preservation in Glioma Peritumoral Edema

he goal of this observational study is to investigate the functional and biological characteristics of the brain tissue surrounding diffuse gliomas, known as peritumoral edema (PTE). The study aims to determine if a non-invasive brain imaging technique, resting-state functional MRI (rs-fMRI), can identify which parts of this edematous tissue are functionally preserved. The main questions it aims to answer are:

Can individualized rs-fMRI mapping accurately distinguish functionally active subregions from non-functional subregions within the peritumoral edema?

Do these functionally preserved regions, identified by imaging, correspond to areas with lower tumor cell infiltration and higher neuronal integrity when examined microscopically?

Participants prospectively enrolled for glioma resection surgery as part of their standard clinical care will undergo preoperative rs-fMRI. This imaging data will be used to create individualized functional network maps of the PTE. During the planned surgery, biopsies will be taken from PTE areas identified by the rs-fMRI analysis as "functionally preserved" and "non-preserved." These tissue samples will then undergo molecular analysis to assess markers for tumor proliferation (Ki-67), invasiveness (Nestin), neuronal integrity (NeuN), and synaptic density (PSD-95, Synapsin-1). Finally, the functional characteristics derived from the preoperative imaging will be correlated with the molecular profiles of the corresponding tissue samples.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Department of Radiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

gliomas

Description

Inclusion Criteria:

Right-handedness Pathologically confirmed diffuse glioma (WHO grade 2-4, based on 2021 WHO classification) Clinical indication for preoperative MRI Clearly delineated FLAIR hyperintensity surrounding the tumor Age 18 years or older Willing and able to provide written informed consent

Exclusion Criteria:

Prior brain biopsy or treatment for glioma Contraindications to MRI (e.g., pacemaker, ferromagnetic implants, severe claustrophobia) Comorbid psychiatric or neurological conditions that may affect functional imaging Head motion exceeding 1.0 mm translation or 1.0° rotation during rs-fMRI acquisition Framewise displacement (FD) greater than 0.2 mm during rs-fMRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Diffuse Glioma Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional connectivity strength of peritumoral edema regions measured by resting-state fMRI
Time Frame: 1-2 weeks before surgery
Nodal connectivity strength between peritumoral edema (PTE) subregions and 17 canonical Yeo functional networks, computed from resting-state fMRI data using individualized functional parcellation. Connectivity strength is calculated as the Pearson correlation coefficient between mean BOLD time series.
1-2 weeks before surgery
Shannon entropy of edge-centric functional connectivity in peritumoral edema regions
Time Frame: 1-2 weeks before surgery
Normalized Shannon entropy (range 0-1) calculated from edge-centric functional connectivity analysis, reflecting the diversity of edge community participation for peritumoral edema subregions. Higher entropy indicates greater integrative complexity.
1-2 weeks before surgery
Ki-67 proliferation index in functionally preserved versus non-preserved peritumoral edema regions
Time Frame: During surgery (intraoperative sampling)
Percentage of Ki-67 positive cells assessed by immunofluorescence staining in intraoperative tissue samples from functionally preserved and non-functionally preserved PTE compartments.
During surgery (intraoperative sampling)
Synaptic marker expression (PSD-95, Synapsin-1) in peritumoral edema subregions
Time Frame: During surgery (intraoperative sampling)
Percentage of PSD-95 and Synapsin-1 positive cells assessed by immunofluorescence in paired tissue samples from functionally preserved and non-preserved PTE regions.
During surgery (intraoperative sampling)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

February 1, 2025

Study Registration Dates

First Submitted

December 20, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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