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Clinical Trials in China / NCT05969691
Active, not recruiting Not applicable

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

NCT05969691 · tracked via the Priya Life Science China tracker
Sponsor
Mingge LLC
Phase
Not applicable
Started
2019-03-15
Last updated
2023-08-08

Condition(s) studied

Glioma, MalignantComputer-Assisted

Investigational drug(s) / intervention(s)

Validation of IDH1 mutations from the radiomics model

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Huashan Hospital, Fudan University Shanghai Shanghai Municipality

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05969691 on ClinicalTrials.gov ↗ ← All trials in China