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Trial Title:
Multi-Dimensional MRI Spatial Heterogeneity Analysis for Predicting Key Genes and Prognosis of High-Grade Gliomas: A Multi-Center Study
NCT ID:
NCT06002711
Condition:
High-grade Glioma
Conditions: Official terms:
Glioma
Conditions: Keywords:
glioma; MRI; spatial heterogeneity; habitat
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
MR scanning; Clinical data collection
Description:
Multi-dimensional spatial heterogeneity analysis of MRI
Arm group label:
Prospective study cohort
Arm group label:
retrospective study cohort
Summary:
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Radiology, Renji hospital, School of Medicine, Shanghai Jiao Tong University
Address:
City:
Shanghai
Zip:
200127
Country:
China
Start date:
September 1, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06002711
