GliomaNCT07343492
fMRI Reveal Functional Preservation in Glioma Peritumoral Edema
An observational study of Glioma, run by West China Hospital at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Glioma
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: gliomas
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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
- Glioma
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diffuse Glioma Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional connectivity strength of peritumoral edema regions measured by resting-state fMRI
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.
Measured: 1-2 weeks before surgery
Shannon entropy of edge-centric functional connectivity in peritumoral edema regions
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.
Measured: 1-2 weeks before surgery
Ki-67 proliferation index in functionally preserved versus non-preserved peritumoral edema regions
Percentage of Ki-67 positive cells assessed by immunofluorescence staining in intraoperative tissue samples from functionally preserved and non-functionally preserved PTE compartments.
Measured: During surgery (intraoperative sampling)
Synaptic marker expression (PSD-95, Synapsin-1) in peritumoral edema subregions
Percentage of PSD-95 and Synapsin-1 positive cells assessed by immunofluorescence in paired tissue samples from functionally preserved and non-preserved PTE regions.
Measured: During surgery (intraoperative sampling)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 May 2020
- Primary completion1 Jan 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simin Zhang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343492
- Sponsor's protocol ID
- 82271961
- Status last verified
- Jan 2026
- First submitted
- 20 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized fMRI and Molecular Profiling Reveal Functional Preservation in Glioma Peritumoral Edema
- ClinicalTrials.gov ID
- NCT07343492
- Acronym / sponsor ID
- 82271961
- Conditions
- Glioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diffuse Glioma Patients | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- gliomas
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional connectivity strength of peritumoral edema regions measured by resting-state fMRI (time frame: 1-2 weeks before surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.