Clinical trial · Observational
fMRI Reveal Functional Preservation in Glioma Peritumoral Edema
Individualized fMRI and Molecular Profiling Reveal Functional Preservation in Glioma Peritumoral Edema
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Diffuse Glioma Patients
Primary outcomes (4)
- measure
- Functional connectivity strength of peritumoral edema regions measured by resting-state fMRI
- timeFrame
- 1-2 weeks before surgery
- description
- 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.
- measure
- Shannon entropy of edge-centric functional connectivity in peritumoral edema regions
- timeFrame
- 1-2 weeks before surgery
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available