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

August 4, 2025 updated by: RenJi Hospital
  1. To retrospectively explore the feasibility of multi-dimensional heterogeneity imaging features of MRI in predicting the status of key gene mutations in high-grade gliomas;
  2. To prospectively explore the correlation between multi-dimensional heterogeneous MRI image features and prognosis of high-grade glioma patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Glioblastoma, the most prevalent primary intracranial tumor, is characterized by its formidable therapeutic resistance, primarily attributed to its intrinsic heterogeneity. This heightened heterogeneity is not solely confined to inter-tumoral variations across different individuals but also encompasses considerable intratumoral diversity. The pervasive notion among the scientific community posits that this intratumoral heterogeneity substantiates an endogenous mechanism for drug resistance, thereby exerting substantial influence upon the design of clinical trials, prognostic prediction, and patient outcomes. Preceding methodologies for assessment are beleaguered by a constellation of challenges, impeding precise evaluation of global tumor heterogeneity and necessitating innovative modalities to surmount this impasse. MRI imaging, endowed with non-invasiveness and user-friendliness, surmounts the biases of single-point sampling, enabling comprehensive and dynamic appraisal of glioblastomas. Notably, high-grade gliomas exhibit pronounced microenvironmental pressure selectivity and adaptability, akin to species occupation within distinct ecological niches. This phenomenon, termed "habitat," manifests as a visual representation of the tumor's spatial distribution and temporal evolution, thus facilitating real-time, longitudinal monitoring. Given the substantial imaging heterogeneity inherent to glioblastomas, they stand as an opportune subject for habitat imaging techniques compared to their neoplastic counterparts.

The present investigation endeavors to leverage multi-center, multi-dimensional MRI spatial heterogeneity analysis to predict pivotal genes germane to prognosis and therapy in high-grade gliomas, ultimately constructing a stratified prognostic model for afflicted patients.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Select a State or Province
      • Shanghai, Select a State or Province, China, 200127
        • Recruiting
        • Department of Radiology, Renji Hospital School of Medicine, Shanghai Jiao Tong University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Active, not recruiting
        • Department of Radiology, Renji hospital, School of Medicine, Shanghai Jiao Tong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

High-grade glioma patients were recruited from multiple research centers, including Renji Hospital, Shanghai Jiao Tong University School of Medicine, Huashan Hospital, Fudan University; Shanghai Jing'an District Central Hospital, and Nantong First People's Hospital.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
retrospective study cohort
In the retrospective study, patient cases will be gathered from multi-center repositories, where surgical cases will be confirmed to be high-grade gliomas and will undergo preoperative contrast-enhanced MRI examinations. These patients will possess comprehensive clinical, pathological, and genetic data.
Diagnostic test: MR scanning; Clinical data collection
Multi-dimensional spatial heterogeneity analysis of MRI
Prospective study cohort
The prospective study will encompass a cohort of individuals who are clinically suspected to have high-grade gliomas and will undergo multimodal MRI imaging. Subsequent to surgery, their postoperative pathology will confirm the diagnosis of high-grade gliomas. Following the surgical intervention, these patients will undergo standard procedures for radiotherapy and chemotherapy, as well as regular follow-up assessments.
Diagnostic test: MR scanning; Clinical data collection
Multi-dimensional spatial heterogeneity analysis of MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival prediction model
Time Frame: 2025.06-2026.09
Survival prediction efficiency of the included samples
2025.06-2026.09
Time-depended ROC curve
Time Frame: 2025.06-2026.09
A time-dependent ROC curve which will be drawn according to the survival analysis.
2025.06-2026.09

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

August 16, 2023

First Submitted That Met QC Criteria

August 16, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RenJiH-Rad-IIT-2023-0141
  • IIT-2023-0141 (Other Identifier: Renji hospital, School of Medicine, Shanghai Jiao Tong University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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