How the Precise Habitats Can Predict the IDH Mutation Status and Prognosis of the Patients With High-grade Gliomas

Study Purpose

High-grade glioma is the most common primary malignant tumor in central nervous system, and its high tumor heterogeneity is the main cause of tumor progression, treatment resistance and recurrence. Habitat imaging is a segmentation technique by dividing tumor regions to characterize tumor heterogeneity based on tumor pathology, blood perfusion, molecular characteristics and other tumor biological features. In some studies, the Hemodynamic Multiparametric Tissue Signature (HTS) method has been proven to be feasible. The Hemodynamic Multiparametric Tissue Signature (HTS) consists of a set of vascular habitats obtained by Dynamic Susceptibility Weighted Contrast Enhanced Magnetic Resonance Imaging (DSC-MRI) of high-grade gliomas using a multiparametric unsupervised analysis method. This allowed them to automatically draw 4 reproducible vascular habitats (High-angiogenic enhancing tumor; Low-angiogenic enhancing tumor; Potentially tumor infiltrated peripheral edema; Vasogenic peripheral edema) which enable to describe the tumor vascular heterogeneity robustly. In other studies, contrast-enhancing mass can divided into spatial habitats by K-means clustering of voxel-wise apparent diffusion coefficient (ADC) and cerebral blood volume (CBV) values to observe the changes of voxels in spatial habitat on the time line. Using this so-called spatiotemporal habitat to identify progression or pseudoprogression in cancer therapy. Above all, we have sufficient and firm reasons to deem that habitat imaging based on multiparametric MRI is more conducive to reflect the potential biological information inside the tumor and realize individualized diagnosis and treatment. To sum up, the assumption of this experiment is that the Habitats Created by preoperative or postoperative Multiparametric MRI ,such as conventional MRI sequences, Dynamic Susceptibility Weighted Contrast Enhanced Magnetic Resonance Imaging (DSC-MRI), Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI), Diffusion Weighted Magnetic Resonance Imaging(DWI) ,Vessel Size Imaging (VSI) ,or Magnetic Resonance Spectroscopy (MRS) can predict the molecular mutation status, prognosis, treatment residence, progression, pseudoprogression, and even recurrence and distant intracranial recurrence in patients with high-grade gliomas.

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 and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria (if we will predict the molecular status and overall survival):

  • - the patient was over 18 years old.
  • - the lesion was located in the supratentorial space; - a histopathologic diagnosis of HGGs according to the WHO CNS4/5; - all subjects were the first diagnosed cases without any invasive or non-invasive treatment; - access to the complete preoperative MR imaging examinations, at least including four conventional sequences.
Inclusion Criteria (if we will differentiate recurrence from distant intracranial recurrence):
  • - the patient was over 18 years old; - the lesion was located in the supratentorial space; - a histopathologic diagnosis of HGGs according to the WHO CNS4/5; - underwent concurrent chemoradiotherapy with temozolomide after surgical resection or biopsy; - underwent preoperative and postoperative MRI, at least including four conventional sequences; - had newly appeared or enlarging, measurable, contrast-enhancing mass which raises clinical suspicion of tumor recurrence and distant intracranial recurrence; - adequate follow-up examinations to determine treatment response on clinic-radiological consensus or pathologic confirmation.

Exclusion Criteria:

  • - patient with other brain tumors or other grade gliomas at the same time; - patient with severe basic diseases at the same time; - patient with a survival time of less than 30 days, which can be caused by severe surgical trauma stress; - poor image quality and heavy artifact affect the subsequent image processing.

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.

NCT04908267
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.

Weiguo Zhang
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Weiguo Zhang, Ph.D
Principal Investigator Affiliation Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

High-grade Glioma
Study Website: View Trial Website
Additional Details

This is a single center experiment. The subjects of this study were patients diagnosed as high-grade glioma by multiparametric magnetic resonance imaging and pathological biopsy from January 1, 2008 to December 31, 2021(or at some interval within this period). Patients meeting the inclusion criteria will enter the next experimental stage. 1. Patients selection: The patients will be clustered according to the preoperative and postoperative examination methods performed by each patient, such as only DSC sequence, both DSC and DWI sequences, or a full set of functional imaging sequences at the same time; 2. Images segmentation: To select the patients who meet the experimental design, and use deep learning-based biomedical image segmentation methods, such as Brain Tumor Segmentation (BraTS) challenge, to segment more accurate and reproducible habitats as much as possible; 3. Construction of clinical model: We may be able to obtain the parameter values of the habitat, such as CBV, ADC, Ktrans, etc. Combining these data with the basic situation of patients can build a clinical model. 4. Construction of radiomics model: The radiomics analysis will probably be structured into four parts: habitats segmentation, feature extraction, feature selection and model construction. 5. We try to analyze that habitat imaging based on Multiparametric MRI is indeed better than the conventional rough and simple ROI analysis; We try to analyze the relation between the habitats and the IDH mutation status or MGMT promoter methylation status; We try to analyze the relation between the habitats and the overall survival (OS) of the patient; We try to analyze the habitats is conducive to differentiate recurrence from distant intracranial recurrence. Finally, statistical methods and survival analysis were used to determine whether the habitat was statistically significant for IDH mutation status and prognosis. For example, receiver operating characteristic curve (ROC) analysis evaluated the potential of the spatial habitats in IDH mutation prediction. The Kaplan-Meier curve evaluates the validation of the diagnosis in OS prediction in high-grade glioma.

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International Sites

Chongqing, Chongqing, China

Status

Recruiting

Address

Department of Radiology, Daping Hospital of Army Medical University

Chongqing, Chongqing, 400042

Site Contact

Jiachen Liu, master

[email protected]

(+86)18434161824

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