Multi-dimensional MRI habitat mapping to predict key gene mutations and prognosis in high-grade gliomas
Official title: Multi-Dimensional MRI Spatial Heterogeneity Analysis for Predicting Key Genes and Prognosis of High-Grade Gliomas: A Multi-Center Study
Run by RenJi Hospital · NCT06002711 · Data updated 2026-11-12
This project will use advanced MRI habitat analysis to try to predict key tumor gene changes and likely outcomes for adults with high-grade gliomas.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Shanghai, Select A State Or Province and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2023 |
| Main results expected | September 30, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | August 8, 2025 |
| Trial ID | NCT06002711 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 with confirmed or suspected WHO grade III–IV high-grade gliomas who have preoperative contrast-enhanced MRIs and molecular testing (retrospective) or who can undergo the protocol MRI and provide informed consent (prospective).
✕Probably not a fit
Patients with low-grade gliomas, those who received prior radiotherapy or chemotherapy before surgery, those without required molecular data, or those unable to tolerate MRI are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multi-center observational project combines a retrospective and a prospective arm to link multi-dimensional MRI heterogeneity features with molecular markers and patient outcomes in WHO grade III–IV gliomas. Retrospective cases with preoperative contrast MRI and available molecular testing will be analyzed to identify imaging features that correlate with mutations such as IDH, MGMT, 1p/19q, TERT, CDKN2A/B and BRAF. Prospectively, patients with suspected high-grade gliomas will undergo a standardized ~40-minute MRI protocol and clinical follow-up to test if the imaging-derived habitats predict prognosis. The approach leverages noninvasive spatial 'habitat' mapping to capture intratumoral heterogeneity across the whole tumor rather than single-point sampling.
Why it matters
Potential benefit: If successful, this approach could let clinicians noninvasively infer tumor genetics and prognosis from MRI scans to better personalize treatment and monitoring.
How similar studies have gone: Prior radiomics and habitat-imaging studies have shown promising correlations between MRI features and molecular markers or outcomes in gliomas, but results remain exploratory and need larger multicenter validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Retrospective Study: 1. Participants aged 18 to 70 years, of any gender. 2. Confirmed postoperative pathology of adult diffuse glioma (WHO Grade III-IV). 3. Standard MR contrast-enhanced imaging performed within 10 days before surgery. 4. No history of prior radiotherapy or chemotherapy before surgery. 5. Absence of concurrent significant comorbidities or other tumors. 6. Presence of molecular testing results (including IDH, MGMT, 1p19q, TERT, CDKN2A/B, BRAF). 7. Availability of comprehensive clinical and follow-up data. Prospective Study: 1. Participants aged 18 to 70 years, of any gender. 2. Clinically suspected to have high-grade gliomas preoperatively, with final pathology confirming high-grade gliomas. 3. Stable vital signs and capable of cooperating for a 40-minute MR scan. 4. Absence of significant underlying medical conditions or history of other tumors. 5. Documentation of informed consent through a signed consent form. Exclusion Criteria: Retrospective Study: 1. MRI images with artifacts or presence of intratumoral hemorrhage. 2. Incomplete clinical data available. Prospective Study: 1. Individuals with claustrophobia or other reasons unable to undergo MRI scans. 2. History of allergic reactions to MRI contrast agents. 3. Inappropriate for prolonged MRI scans due to other reasons.
Where it's running
-
Department of Radiology, Renji Hospital School of Medicine, Shanghai Jiao Tong University
Shanghai, Select A State Or Province, China Recruiting -
Department of Radiology, Renji hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China Active not recruiting
Study contacts
- Study coordinator: Yan Zhou, MD,PhD
- Email: clare1475@hotmail.com
- Phone: +86-021-68383086
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.