NCT06002711

Brief Summary

  1. 1.To retrospectively explore the feasibility of multi-dimensional heterogeneity imaging features of MRI in predicting the status of key gene mutations in high-grade gliomas;
  2. 2.To prospectively explore the correlation between multi-dimensional heterogeneous MRI image features and prognosis of high-grade glioma patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
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 Progress62%
Sep 2023Dec 2027

First Submitted

Initial submission to the registry

August 16, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

3.1 years

First QC Date

August 16, 2023

Last Update Submit

August 4, 2025

Conditions

High-grade Glioma

Keywords

glioma; MRI; spatial heterogeneity; habitat

Outcome Measures

Primary Outcomes (2)

  • Survival prediction model

    Survival prediction efficiency of the included samples

    2025.06-2026.09

  • Time-depended ROC curve

    A time-dependent ROC curve which will be drawn according to the survival analysis.

    2025.06-2026.09

Study Arms (2)

retrospective study cohort

In the retrospective study, patient cases will be gathered from multi-center repositories, where surgical cases will be confirmed to be high-grade gliomas and will undergo preoperative contrast-enhanced MRI examinations. These patients will possess comprehensive clinical, pathological, and genetic data.

Diagnostic Test: MR scanning; Clinical data collection

Prospective study cohort

The prospective study will encompass a cohort of individuals who are clinically suspected to have high-grade gliomas and will undergo multimodal MRI imaging. Subsequent to surgery, their postoperative pathology will confirm the diagnosis of high-grade gliomas. Following the surgical intervention, these patients will undergo standard procedures for radiotherapy and chemotherapy, as well as regular follow-up assessments.

Diagnostic Test: MR scanning; Clinical data collection

Interventions

MR scanning; Clinical data collectionDIAGNOSTIC_TEST

Multi-dimensional spatial heterogeneity analysis of MRI

Prospective study cohortretrospective study cohort

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

High-grade glioma patients were recruited from multiple research centers, including Renji Hospital, Shanghai Jiao Tong University School of Medicine, Huashan Hospital, Fudan University; Shanghai Jing'an District Central Hospital, and Nantong First People's Hospital.

You may qualify if:

  • Retrospective Study:
  • Participants aged 18 to 70 years, of any gender.
  • Confirmed postoperative pathology of adult diffuse glioma (WHO Grade III-IV).
  • Standard MR contrast-enhanced imaging performed within 10 days before surgery.
  • No history of prior radiotherapy or chemotherapy before surgery.
  • Absence of concurrent significant comorbidities or other tumors.
  • Presence of molecular testing results (including IDH, MGMT, 1p19q, TERT, CDKN2A/B, BRAF).
  • Availability of comprehensive clinical and follow-up data.
  • Prospective Study:
  • Participants aged 18 to 70 years, of any gender.
  • Clinically suspected to have high-grade gliomas preoperatively, with final pathology confirming high-grade gliomas.
  • Stable vital signs and capable of cooperating for a 40-minute MR scan.
  • Absence of significant underlying medical conditions or history of other tumors.
  • Documentation of informed consent through a signed consent form.

You may not qualify if:

  • Retrospective Study:
  • MRI images with artifacts or presence of intratumoral hemorrhage.
  • Incomplete clinical data available.
  • Prospective Study:
  • Individuals with claustrophobia or other reasons unable to undergo MRI scans.
  • History of allergic reactions to MRI contrast agents.
  • Inappropriate for prolonged MRI scans due to other reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Radiology, Renji Hospital School of Medicine, Shanghai Jiao Tong University

Shanghai, Select A State Or Province, 200127, China

RECRUITING

Department of Radiology, Renji hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

ACTIVE NOT RECRUITING

Related Publications (5)

  • Cao M, Wang X, Liu F, Xue K, Dai Y, Zhou Y. A three-component multi-b-value diffusion-weighted imaging might be a useful biomarker for detecting microstructural features in gliomas with differences in malignancy and IDH-1 mutation status. Eur Radiol. 2023 Apr;33(4):2871-2880. doi: 10.1007/s00330-022-09212-5. Epub 2022 Nov 8.

    PMID: 36346441BACKGROUND

  • Cao M, Suo S, Zhang X, Wang X, Xu J, Yang W, Zhou Y. Qualitative and Quantitative MRI Analysis in IDH1 Genotype Prediction of Lower-Grade Gliomas: A Machine Learning Approach. Biomed Res Int. 2021 Jan 22;2021:1235314. doi: 10.1155/2021/1235314. eCollection 2021.

    PMID: 33553421BACKGROUND

  • Cao M, Ding W, Han X, Suo S, Sun Y, Wang Y, Qu J, Zhang X, Zhou Y. Brain T1rho mapping for grading and IDH1 gene mutation detection of gliomas: a preliminary study. J Neurooncol. 2019 Jan;141(1):245-252. doi: 10.1007/s11060-018-03033-7. Epub 2018 Nov 9.

    PMID: 30414094BACKGROUND

  • Dextraze K, Saha A, Kim D, Narang S, Lehrer M, Rao A, Narang S, Rao D, Ahmed S, Madhugiri V, Fuller CD, Kim MM, Krishnan S, Rao G, Rao A. Spatial habitats from multiparametric MR imaging are associated with signaling pathway activities and survival in glioblastoma. Oncotarget. 2017 Dec 5;8(68):112992-113001. doi: 10.18632/oncotarget.22947. eCollection 2017 Dec 22.

    PMID: 29348883BACKGROUND

  • Park JE, Kim HS, Kim N, Park SY, Kim YH, Kim JH. Spatiotemporal Heterogeneity in Multiparametric Physiologic MRI Is Associated with Patient Outcomes in IDH-Wildtype Glioblastoma. Clin Cancer Res. 2021 Jan 1;27(1):237-245. doi: 10.1158/1078-0432.CCR-20-2156. Epub 2020 Oct 7.

    PMID: 33028594BACKGROUND

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

Yan Zhou, MD,PhD

CONTACT

+86-021-68383086clare1475@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 21, 2023

Study Start

September 1, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

August 8, 2025

Record last verified: 2025-08

Locations

CN(2)