MRI Contrast Clearance Analysis for Glioma Grading and Genotyping

Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06018870
Collaborator
(none)
100
1
13
7.7

Study Details

Study Description

Brief Summary

Gliomas are the most common primary brain tumor. Gliomas with different grades have different clinical behaviors that determine treatment planning and patient prognosis in clinical practice. In the 2021 World Health Organization (WHO) classification of tumors for the central nervous system, glioma genotyping was considered the most relevant information for neuroradiologists. The isocitrate dehydrogenase (IDH) genotype and 1p/19q codeletion status are two essential molecular markers that divide glioma into three groups: IDH wild-type, IDH mutant with 1p/19q non-codeletion, and IDH mutant with 1p/19q codeletion.

MRI contrast clearance analysis (CCA) is based on T1 delayed-contrast subtraction map, Blue/tumor regions in CCA represent efficient clearance of contrast from the tissue (delayed signal<early signal), while red/nontumor regions in CCA represent contrast accumulation (delayed signal>early signal).

However, there are not any reports on the role of MRI CCA in glioma grading and genotyping, Thus, We hypothesized that the proportion of blue/red region and their histogram analyses, which could be acquired for predicting IDH genotypes and 1p/19q codeletion in gliomas, and to assess the application of CCA in glioma grading.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a single-center bidirectional cohort study. The subjects of this study were patients diagnosed as glioma by pathological biopsy. Patients with suspicious mass will be performed extra 30 and 60 min after contrast agent application delayed T1-weighted sequences as same as before. Then enter the next experimental stage. (1) Image format conversion; (2) Registration;(3) Subtraction;(4) ROI segmentation;(5) ROI histogram analyses. Histogram parameters of blue and red ROI includes 1st、10th 、90th and 99th percentiles, mean, median, variance, skewness, and kurtosis.

    Finally, statistical methods were used to determine whether those parameters was statistically significant for IDH mutation status、1p/19q codeletion status and tumor grading.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    MRI Contrast Clearance Analysis for Prediction of Grading and Genotyping in Gliomas
    Actual Study Start Date :
    Jun 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Jun 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of bule/red ROI [Through study completion, an average of 1 year]

      The common vessels morphology in the blue region was undamaged vessel lumens which exists in active tumor, while vessels in the red regions presented different stages of vessel necrosis.

    2. Histogram of bule/red ROI [Through study completion, an average of 1 year]

      The bule and red ROI from CCA histogram analysis included1st、10th 、90th and 99th percentiles, mean, median, variance, skewness, and kurtosis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with brain space -occupying lesions, have not yet undergone antitumor therapy;

    • MRI with T1-contract delayed sequence was performed less than 2 weeks before surgery;

    • Definite histopathologic diagnosis of glioma.

    Exclusion Criteria:
    • WHO 1 gliomas and other non-glioma brain tumors;

    • Poor image quality and heavy artifact affect the subsequent image processing.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sang Zifan Chongqing Chongqing China 400042

    Sponsors and Collaborators

    • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Weiguo Zhang, Chief of radiology department, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
    ClinicalTrials.gov Identifier:
    NCT06018870
    Other Study ID Numbers:
    • 2023183
    First Posted:
    Aug 31, 2023
    Last Update Posted:
    Aug 31, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Weiguo Zhang, Chief 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 31, 2023