- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07343492
fMRI Reveal Functional Preservation in Glioma Peritumoral Edema
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
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sichuan
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Chengdu, Sichuan, China, 610041
- Department of Radiology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Diffuse Glioma Patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Functional connectivity strength of peritumoral edema regions measured by resting-state fMRI
Time Frame: 1-2 weeks before surgery
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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.
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1-2 weeks before surgery
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Shannon entropy of edge-centric functional connectivity in peritumoral edema regions
Time Frame: 1-2 weeks before surgery
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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.
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1-2 weeks before surgery
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Ki-67 proliferation index in functionally preserved versus non-preserved peritumoral edema regions
Time Frame: During surgery (intraoperative sampling)
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Percentage of Ki-67 positive cells assessed by immunofluorescence staining in intraoperative tissue samples from functionally preserved and non-functionally preserved PTE compartments.
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During surgery (intraoperative sampling)
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Synaptic marker expression (PSD-95, Synapsin-1) in peritumoral edema subregions
Time Frame: During surgery (intraoperative sampling)
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Percentage of PSD-95 and Synapsin-1 positive cells assessed by immunofluorescence in paired tissue samples from functionally preserved and non-preserved PTE regions.
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During surgery (intraoperative sampling)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 82271961
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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