Radiomics-Based Visualization and Quantitative Validation of IDH1 Heterogeneity in Gliomas

Summary

The goal of this clinical trail is to non-invasively visualise and quantitatively validate an radiomics model of genetic heterogeneity in adult patients with diffuse glioma to help clinicians better guide surgical resection and treatment options. It aims to answer are:

1. To overcome the limitations of the existing genetic diagnostic process in terms of equipment and technology requirements, high costs and long timelines, and to enable quantitative studies of isocitrate dehydrogenase 1 (IDH1) mutations, thus allowing refined patient stratification and further exploration of the role of molecular markers in improving patient prognosis.
2. To achieve non-invasive diagnosis of gene mutations within tumours by taking advantage of artificial intelligence and medical images, and to test the clinical feasibility of the model through typical target puncture, gene sequencing and quantitative gene expression analysis.

Participants will read an informed consent agreement before surgery and voluntarily decide whether or not to join the experimental group. They will undergo preoperative magnetic resonance imaging, intraoperative brain puncture of typical tumour sites, and postoperative genotype identification. Their imaging data, genotype data, clinical history data, and pathology data will be used for the experimental study.

Conditions

• Glioma, Malignant
• Computer-Assisted

Interventions

DIAGNOSTIC_TEST

Validation of IDH1 mutations from the radiomics model

During surgery, clinicians will select several typical target sites for puncture based on the preoperative model outputs. After surgery, the acquired tumour tissues will be subjected to histological diagnosis and pathological diagnosis by professional pathologists, and the results will be compared with the model output to verify its accuracy.

Sponsors & Collaborators

• Huashan Hospital

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Mingge LLC

  lead INDUSTRY

Principal Investigators

• Ying Mao, DM · Huashan Hospital

• Zhifeng Shi, DM · Huashan Hospital

• Jinhua Yu, DE · Fudan University

• Zengxin Qi, DM · Huashan Hospital

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-15

Primary Completion

2025-12-15

Completion

2026-12-15

Countries

• China

Study Locations