NCT06018870

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

August 24, 2023

Last Update Submit

August 29, 2023

Conditions

Keywords

Glioma

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Through study completion, an average of 1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sang Zifan

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Central Study Contacts

Zifan Sang, M.M

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of radiology department

Study Record Dates

First Submitted

August 24, 2023

First Posted

August 31, 2023

Study Start

June 1, 2023

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

August 31, 2023

Record last verified: 2023-08

Locations