NCT06572592

Brief Summary

The goal of this observational study is to learn about the diagnostic value of preoperative MRI examination for adult-type diffuse gliomas. The main question it aims to answer is:

  • Can preoperative MRI examination noninvasively predict genotype of gliomas?
  • Can preoperative MRI examination noninvasively predict the overall survival of gliomas?
  • Can preoperative MRI examination noninvasively predict Ki-67 proliferation status?

Trial Health

65
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Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Aug 2024

Longer than P75 for all trials

Status
not yet recruiting

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 Progress34%
Aug 2024May 2030

First Submitted

Initial submission to the registry

August 22, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

August 22, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Expected
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

August 22, 2024

Last Update Submit

August 25, 2024

Conditions

Keywords

gliomaMRIIDHKi-67

Outcome Measures

Primary Outcomes (1)

  • A model for predicting glioma grade and the status of prognosis-related molecular mutations, constructed using multiparametric MRI

    The prognosis-related molecular mutation status, such as IDH mutation, is classified as dichotomous data. Mutations, deletions, or amplifications are categorized into the positive group and are denoted as 1; the absence of mutation, deletion, or amplification is categorized into the negative group and is denoted as 0.

    Through study completion, an average of 7 years

Study Arms (1)

Adult-type diffuse gliomas

Inclusion Criteria: 1. First diagnosis of glioma, with no preoperative radiotherapy or chemotherapy. 2. Underwent multiparametric MRI examination in our hospital before surgery. 3. Tumor resection or biopsy was performed within 3 weeks after MRI examination. 4. Pathological examination confirmed glioma. Exclusion Criteria: 1. Inability to cooperate during MRI examination, resulting in poor image quality that prevents image analysis. 2. Surgery or biopsy specimens were unqualified and could not be analyzed pathologically.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study Site and Population Study Site: The First Affiliated Hospital of Sun Yat-sen University; Patients with glioma

You may qualify if:

  • First diagnosis of glioma, with no preoperative radiotherapy or chemotherapy.
  • Underwent multiparametric MRI examination in our hospital before surgery.
  • Tumor resection or biopsy was performed within 3 weeks after MRI examination.
  • Pathological examination confirmed glioma.

You may not qualify if:

  • Inability to cooperate during MRI examination, resulting in poor image quality that prevents image analysis.
  • Surgery or biopsy specimens were unqualified and could not be analyzed pathologically.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Huang Y, He S, Hu H, Ma H, Huang Z, Zeng S, Mazu L, Zhou W, Zhao C, Zhu N, Wu J, Liu Q, Yang Z, Wang W, Shen G, Zhang N, Chu J. Added prognostic value of histogram features from preoperative multi-modal diffusion MRI in predicting Ki-67 proliferation for adult-type diffuse gliomas. Quant Imaging Med Surg. 2025 Sep 1;15(9):8423-8439. doi: 10.21037/qims-2025-242. Epub 2025 Aug 19.

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms.

Study Record Dates

First Submitted

August 22, 2024

First Posted

August 27, 2024

Study Start

August 22, 2024

Primary Completion

May 1, 2025

Study Completion (Estimated)

May 1, 2030

Last Updated

August 27, 2024

Record last verified: 2024-08