How the Habitats Created by MRI Can Predict the IDH Mutation Status and Prognosis of the Patients With High-grade Glioma

Sponsor
Weiguo Zhang (Other)
Overall Status
Recruiting
CT.gov ID
NCT04908267
Collaborator
(none)
100
1
29
3.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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. 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    To Determine Whether the Habitats Created by the Preoperative or Postoperative Multiparametric MRI Can Predict IDH Mutation Status, Prognosis, Recurrence or Intracranial Distant Recurrence of the Patients With High-grade Glioma
    Actual Study Start Date :
    Aug 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between the overall survival time (in days) of the patients with high-grade glioma and the habitat created by multiparametric MRI [From the date of operation until the date of death from any causeļ¼Œassessed up to 90 months]

      The overall survival for each patient is estimated since the date of operation to the end of recruitment. The overall survival will be confirmed through clinical follow-up.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria (if we will predict the molecular status and overall survival):
    • (1) no prior history of chemotherapy, radiation therapy; (2) a histopathologic diagnosis of WHO grade 3 and 4 gliomas according to the 2021 WHO criteria; (3) known IDH genotype; (4) access to preoperative MR imaging examinations, including conventional MRI sequences and T1-contrast enhancement at least; (5) patients with a survival time of more than 30 days, with the exception of severe surgical trauma.

    Inclusion Criteria (if we will differentiate recurrence from distant intracranial recurrence):

    • (1) a histopathologic diagnosis of WHO grade 3 and 4 gliomas according to the 2021 WHO criteria; (2) underwent concurrent chemoradiotherapy with temozolomide after surgical resection or biopsy; (3) underwent preoperative and postoperative MRI, including conventional MRI sequences and T1-contrast enhancement at least; (4) had newly appeared or enlarging, measurable, contrast-enhancing mass which raises clinical suspicion of tumor recurrence and distant intracranial recurrence; (5) adequate follow-up examinations to determine treatment response on clinic-radiological consensus or pathologic confirmation.
    Exclusion Criteria:
    • (a) poor quality images; (b) errors when processed imaging with automatic segmentation pipeline (c) suffering from other intracranial tumors at the same time

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Radiology, Daping Hospital of Army Medical University Chongqing Chongqing China 400042

    Sponsors and Collaborators

    • Weiguo Zhang

    Investigators

    • Study Chair: weiguo Zhang, Ph.D., Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Weiguo Zhang, Director of Radiology Department, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
    ClinicalTrials.gov Identifier:
    NCT04908267
    Other Study ID Numbers:
    • 2022198
    First Posted:
    Jun 1, 2021
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Weiguo Zhang, Director of Radiology Department, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 3, 2022