MRI Contrast Clearance Analysis for Glioma Grading and Genotyping

August 29, 2023 updated by: Weiguo Zhang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

MRI Contrast Clearance Analysis for Prediction of Grading and Genotyping in Gliomas

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • Sang Zifan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The subjects are not restricted by gender and age. For details, please refer to the "criteria" column.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of bule/red ROI
Time Frame: 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.
Through study completion, an average of 1 year
Histogram of bule/red ROI
Time Frame: 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.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023183

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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