Clinical trial · Interventional
Radiomics-Based Visualization and Quantitative Validation of IDH1 Heterogeneity in Gliomas
Radiomics-Based Visualization and Quantitative Validation of Isocitrate Dehydrogenase 1 Heterogeneity in Gliomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Computer-Assisted | — | UNRESOLVED | — |
| Glioma, Malignant | Malignant Glioma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Validation of IDH1 mutations from the radiomics model | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Validation of IDH1 mutations from the radiomics model
- description
- In this experiment, we validate the accuracy of radiomics model for IDH1 prediction by puncturing typical targets of gliomas, gene sequencing and quantitative gene analysis.
- interventionNames
- Diagnostic Test: Validation of IDH1 mutations from the radiomics model
Primary outcomes (1)
- measure
- accuracy
- timeFrame
- End of study (24 weeks)
- description
- The ratio of correct model predictions to all predictions is calculated by comparing the results with the puncture results.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18-70 years, male or female; * Patients with complete preoperative magnetic resonance imaging and were initially diagnosed with glioma based on the magnetic resonance imaging results; * Patients who were proposed for craniectomy without contraindications to surgery and who had signed an informed consent form by themselves or their proxy; * Patients with confirmed diagnosis of glioma by postoperative pathological diagnosis. Exclusion Criteria: * Patients to be admitted for a simple puncture biopsy; * Patients with a combination of serious medical conditions and those who cannot tolerate surgery; * Patients with a bleeding tendency or abnormal coagulation function, or those who have not discontinued long-term use of anticoagulants such as aspirin and clopidogrel; * Pregnant and breastfeeding women; * Patients participate in other clinical trials during the same period.
References
Publications (0)
Data not yet available