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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 70 Years
Gender	All

More 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06002711
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	RenJi Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	High-grade Glioma

Additional Details

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.

Arms & Interventions

Arms

: 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.

: 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.

Interventions

Diagnostic Test: - MR scanning; Clinical data collection

Multi-dimensional spatial heterogeneity analysis of MRI

Contact a Trial Team

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International Sites

Shanghai, Shanghai, China

Status

Address

Department of Radiology, Renji hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai, 200127

Site Contact

[email protected]

+86-021-68383086

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