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Radiomics-Based Visualization and Quantitative Validation of IDH1 Heterogeneity in Gliomas
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 80 Years |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05969691 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Mingge LLC |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Ying Mao, DMZhifeng Shi, DMJinhua Yu, DEZengxin Qi, DM |
Principal Investigator Affiliation | Huashan HospitalHuashan HospitalFudan UniversityHuashan Hospital |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry, Other |
Overall Status | Active, not recruiting |
Countries | China |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Glioma, Malignant, Computer-Assisted |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.