Radiomics-Based Visualization and Quantitative Validation of IDH1 Heterogeneity in Gliomas
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ClinicalTrials.gov Identifier: NCT05969691 |
Recruitment Status :
Active, not recruiting
First Posted : August 1, 2023
Last Update Posted : August 8, 2023
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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:
- 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.
- 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.
Condition or disease | Intervention/treatment | Phase |
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Glioma, Malignant Computer-Assisted | Diagnostic Test: Validation of IDH1 mutations from the radiomics model | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Radiomics-Based Visualization and Quantitative Validation of Isocitrate Dehydrogenase 1 Heterogeneity in Gliomas |
Actual Study Start Date : | March 15, 2019 |
Estimated Primary Completion Date : | December 15, 2025 |
Estimated Study Completion Date : | December 15, 2026 |
Arm | Intervention/treatment |
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Experimental: Validation of IDH1 mutations from the radiomics model
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.
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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. |
- accuracy [ Time Frame: End of study (24 weeks) ]The ratio of correct model predictions to all predictions is calculated by comparing the results with the puncture results.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05969691
China, Shanghai | |
Huashan Hospital, Fudan University | |
Shanghai, Shanghai, China, 200433 |
Study Chair: | Ying Mao, DM | Huashan Hospital | |
Study Director: | Zhifeng Shi, DM | Huashan Hospital | |
Study Director: | Jinhua Yu, DE | Fudan University | |
Principal Investigator: | Zengxin Qi, DM | Huashan Hospital |
Responsible Party: | Mingge LLC |
ClinicalTrials.gov Identifier: | NCT05969691 |
Other Study ID Numbers: |
MINGGE-SW-00003-V1-01 |
First Posted: | August 1, 2023 Key Record Dates |
Last Update Posted: | August 8, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | All patient information collected by the Huashan Hospital will be kept strictly confidential. We will share the results and findings of the study with other researchers. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Genetic Heterogeneity Gliomas Computer-Assisted Diagnosis |
Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |