An observational study in Glioma, sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2023-08-31.
Sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Observational
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.
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.
1,425 studies on the registry are indexed under Glioma; 355 are open to participants now.
This study's planned enrollment of 100 is above the median of 82 across 243 observational studies indexed under Glioma.
Browse Glioma studies →Daping Hospital and the Research Institute of Surgery of the Third Military Medical University is the lead sponsor of 120 studies on the registry; 42 are open to participants now.
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The subjects are not restricted by gender and age. For details, please refer to the "criteria" column.
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Exclusion Criteria:
Proportion of bule/red ROI
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.
Time frame: Through study completion, an average of 1 year
Histogram of bule/red ROI
The bule and red ROI from CCA histogram analysis included1st、10th 、90th and 99th percentiles, mean, median, variance, skewness, and kurtosis.
Time frame: Through study completion, an average of 1 year
Started Jun 2023 (actual). Primary completion is estimated for Dec 2023, 6 months after the start.
Of 105 non-industry observational studies under Glioma, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 104. This study's planned 6 months is below that.
Counting every sponsor, half of 113 studies reached it within 60 months; a quarter within 27 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University →