跳至主要内容
临床试验/NCT06018870
NCT06018870招募中不适用

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

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Proportion of bule/red ROI

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • WHO 1 gliomas and other non-glioma brain tumors;
  • Poor image quality and heavy artifact affect the subsequent image processing.

结局指标

主要结局

Proportion of bule/red ROI

时间窗: 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.

Histogram of bule/red ROI

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Weiguo Zhang

Chief of radiology department

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

研究点 (1)

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