Clinical Trials Logo

Clinical Trial Summary

The aim of this observational study is to enable rapid diagnosis of molecular biomarkers in patients during surgery by medical imaging and artificial intelligence models, to help clinicians with strategies to maximize safe resection of gliomas. The main questions it aims to answer are: 1. To solve the current clinical shortcomings of intraoperative molecular diagnosis, which is time-consuming and complex, and enables rapid and automated molecular diagnosis of glioma, thus providing the possibility of personalized tumor resection plans. 2. To implement a neuro-navigation platform that combines preoperative magnetic resonance images, intraoperative ultrasound signals and intraoperative ultrasound images to address real-time molecular boundary visualisation and molecular diagnosis for glioma, providing an approach to improve glioma treatment. 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 ultrasound, and postoperative genotype identification. Their imaging data, genotype data, clinical history data, and pathology data will be used for the experimental study. The data collection process will not interrupt the normal surgical process.


Clinical Trial Description

BACKGROUND: The extent of glioma resection is directly related to patient survival, and a combination of multiple imaging and molecular pathology imaging methods has been developed to achieve maximum safe resection. In this study, three types of data, preoperative magnetic resonance imaging, intraoperative ultrasound and molecular genotype, will be collected and combined to build an artificial intelligence imaging model to achieve maximum safe resection and prolong patient's life. PLAN: In order to achieve the goal of maximum safe resection, we plan to sequentially implement imaging-based molecular visualization techniques, and integrated guidance techniques through a combination of intraoperative ultrasound and preoperative magnetic resonance imaging, in order to address the two critical scientific issues of glioma molecular boundary visualization and intraoperative real-time molecular diagnosis. It can also help neurosurgeons to achieve complete glioma resection at the molecular level, maximizing patient survival time and providing another effective approach to improving glioma treatment. PROCESS: 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 and intraoperative ultrasound to obtain magnetic resonance images, ultrasound images, and ultrasound radio-frequency signals. After surgery, the patient's tumor tissue samples will undergo specialist genetic testing to obtain multiple molecular diagnostic results, such as isocitrate dehydrogenase (IDH), telomerase reverse transcriptase promoter (TERTp), the short arm chromosome 1 and the long arm of chromosome 19 (1p/19q), et al. Also, their imaging data, genotype data, clinical history data, and pathology data will be used for the experimental study. The data collected from each patient will be performed in three steps as follows. 1. Image translation and alignment of intraoperative ultrasound and preoperative MRI navigation across modalities for glioma. 2. Multimodality imaging of IDH1/2 gene mutations from structural to molecular boundaries. 3. Applied study of molecular boundary visualization. All the above information will be summarized and handed over to Fudan University to build an artificial intelligent model. Compared with the previous gold standard glioma resection, this study adds intraoperative ultrasound, intraoperative multi-point tumor specimen sampling for IDH genotype identification during the surgery, and will collect relevant molecular imaging data, MRI data, intraoperative ultrasound data, clinical case data and pathology data from patients after the surgery. Intraoperative ultrasound is non-invasive, real-time and rapid, without adding additional operative time or risk of infection. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05656053
Study type Observational [Patient Registry]
Source Mingge LLC
Contact
Status Active, not recruiting
Phase
Start date November 15, 2021
Completion date September 2026

See also
  Status Clinical Trial Phase
Recruiting NCT05557240 - Neoantigens Phase I Trial in Newly Diagnosed Glioblastoma Patients N/A
Recruiting NCT05474573 - Concurrent Fluorescence and Sonographically Guided Eradication of Contrast-enhancing Gliomas and Metastases N/A
Recruiting NCT05485038 - General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas N/A
Active, not recruiting NCT04547621 - HSRT and IMRT Chemoradiotherapy for Newly Diagnosed GBM Phase 1/Phase 2
Recruiting NCT05076513 - Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma Early Phase 1
Completed NCT05806619 - Glioma: Biomolecular Aspects
Not yet recruiting NCT04562077 - Role of Surgery in Treatment of Recurrent Brian Glioma:Prognostic Factors and Outcome
Recruiting NCT06038760 - Prospective Evaluation of AI R&D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO)
Completed NCT04497142 - Effect of Perampanel on Peritumoral Hyperexcitability in HGG Phase 1/Phase 2
Recruiting NCT05500508 - Oral AMXT 1501 Dicaprate in Combination With IV DFMO Phase 1/Phase 2
Recruiting NCT06196918 - Efficacy and Safety of Rivaroxaban in the Prevention of Venous Thromboembolism in Glioma Patients N/A
Recruiting NCT05556486 - Mapping of Tumor Stem Cells in the Resection Marigin During Extirpation of Highly Malignant Gliomas Using GlioStem
Recruiting NCT05406700 - Niraparib In Recurrent IDH 1/2 Gliomas Early Phase 1
Recruiting NCT05773326 - Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG Early Phase 1
Active, not recruiting NCT05063682 - The Efficacy and Safety of Brain-targeting Immune Cells (EGFRvIII-CAR T Cells) in Treating Patients With Leptomeningeal Disease From Glioblastoma. Administering Patients EGFRvIII -CAR T Cells May Help to Recognize and Destroy Brain Tumor Cells in Patients Phase 1
Completed NCT05100602 - Clinical Evaluation of Genetron TERT PCR Kit in Glioma Patients
Completed NCT05100173 - Clinical Evaluation of Genetron IDH1 PCR Kit in Glioma Patients
Recruiting NCT05182905 - AZD1390 in Recurrent and Newly Diagnosed WHO Grade 4 Glioma Patients Early Phase 1
Recruiting NCT06381726 - Personalized Rendering of Motor System Functional Plasticity Potential to Improve Glioma Resection and Quality of Life N/A
Completed NCT03434262 - SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors Phase 1