Multi-dimensional MRI habitat mapping to predict key gene mutations and prognosis in high-grade gliomas

Multi-Dimensional MRI Spatial Heterogeneity Analysis for Predicting Key Genes and Prognosis of High-Grade Gliomas: A Multi-Center Study

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
• Enrollment: 500 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Shanghai, Select A State Or Province and 1 other locations)
• Trial ID: NCT06002711 on ClinicalTrials.gov

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.

Who should consider this trial

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).

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.

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 performed: 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.

Eligibility 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 this trial is running

Shanghai, Select A State Or Province and 1 other locations

• 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

Conditions High-grade Glioma; glioma; MRI; spatial heterogeneity; habitat