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

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ClinicalTrials.gov Identifier: NCT04908267
Recruitment Status : Not yet recruiting
First Posted : June 1, 2021
Last Update Posted : June 1, 2021
Sponsor:
Information provided by (Responsible Party):
Weiguo Zhang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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 allows us to automatically draw 4 reproducible habitats which enable to describe the tumor vascular heterogeneity:

  1. The High Angiogenic enhancing Tumor (HAT)
  2. The Less Angiogenic enhancing Tumor (LAT)
  3. The potentially tumor Infiltrated Peripheral Edema (IPE)
  4. The Vasogenic Peripheral Edema (VPE)

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 sum up, the assumption of this experiment is that the Habitats Created by The Hemodynamic Multiparametric Tissue Signature (HTS) and apparent diffusion coefficient (ADC) can predict isocitrate dehydrogenase (IDH) mutation status and the overall survival of patients with high-grade glioma.


Condition or disease
High-grade Glioma

Detailed Description:

This is a single center experiment. The subjects of this study were patients diagnosed as high-grade glioma by multi-parameter magnetic resonance imaging and pathological biopsy from January 1, 2014 to the beginning of recruitment. Patients meeting the inclusion criteria will enter the next experimental stage.

(i) four reproducible blood flow habitats are automatically segmented by HTS method;

(ii) On the basis of four vascular heterogeneity habitats, the apparent diffusion coefficient (ADC) was registered to form a more accurate habitat.

(iii) To analyse the relation between the spatial habitats and the IDH mutation status; To analyse the relation between the spatial habitats and the overall survival (OS) of the patient;

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.

There are still many parameters to use in the future. We can use Dynamic Contrast Enhancement Magnetic Resonance Imaging (DCE-MRI) to reflect the degree of angiogenesis and vascular permeability, can use Magnetic Resonance Spectroscopy (MRS) to reflect metabolism. Multiparametric MRI is more conducive to reflect the potential biological information inside the tumor and realize individualized diagnosis and treatment.

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: To Determine Whether the Habitats Created by the Preoperative Perfusion and Diffusion MRI Can Predict IDH Mutation Status and the Overall Survival of Patients With High-grade Glioma
Estimated Study Start Date : June 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Correlation between the overall survival time (in days) of the patients with high-grade glioma and the habitat created by perfusion and diffusion imaging [ Time Frame: From the date of the first MRI acquisition until the date of death from any cause,assessed up to 90 months ]
    The overall survival for each patient is estimated since the date of the preoperative Magnetic Resonance Imaging to the end of recruitment. The overall survival will be confirmed through clinical follow-up.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The subjects we selected are adults who are not restricted by gender. There have some inclusion criteria: (a) no prior history of chemotherapy, radiation therapy, or corticosteroid treatment; (b) a histopathologic diagnosis of WHO grade-III gliomas and GBM according to the WHO criteria; (c) known IDH genotype; (d) access to preoperative MR imaging examinations, including perfusion imaging and diffusion imaging.
Criteria

Inclusion Criteria:

  • (a) no prior history of chemotherapy, radiation therapy, or corticosteroid treatment; (b) a histopathologic diagnosis of WHO grade-III gliomas and GBM according to the WHO criteria; (c) known IDH genotype; (d) access to preoperative MR imaging examinations, including perfusion imaging and diffusion imaging.

Exclusion Criteria:

  • (a) poor quality images; (b) errors when processed with automatic pipeline (c) suffering from other intracranial tumors at the same time

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04908267


Contacts
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Contact: Jiachen Liu, M.D. (+86)18434161824 JCliu0430@163.com

Sponsors and Collaborators
Weiguo Zhang
Investigators
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Study Chair: weiguo Zhang, Ph.D. Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Additional Information:
Publications:
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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: 20210501
First Posted: June 1, 2021    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue