Intraoperative Rapid Diagnosis of Glioma Based on Fusion of Magnetic Resonance and Ultrasound Imaging

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Intraoperative Rapid Diagnosis of Glioma Based on Fusion of Magnetic Resonance and Ultrasound Imaging

Study Purpose

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.

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.	Observational [Patient Registry]
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age over 18 years old.

- Tumor in non-functional areas of the cerebral hemisphere.

- Preoperative diagnosis of glioma.

- Undergo glioma removal surgery.

Exclusion Criteria:

- Postoperative confirmation of non-glioma.

- Magnetic resonance or ultrasound data not available.

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.	NCT05656053
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.
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.	Zhifeng Shi, DMJinhua Yu, DEYinhui Deng, DE
Principal Investigator Affiliation	Huashan HospitalFudan UniversityFudan University
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 Surgery

Additional Details

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.

Arms & Interventions

Arms

: Patients undergoing glioma removal surgery

Patients will undergo magnetic resonance examination before surgery, followed by rapid ultrasound acquisition of the tumor section by the surgeon during surgery and the resection of the tumor tissue for cryopreservation. After surgery, the tissue sample will be used for genetic sequencing and mass spectrometry to obtain molecular information. The data involved in the overall surgical procedure will be saved and used in this observational study.

Interventions

Contact a Trial Team

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International Sites

Fudan University, Shanghai, Shanghai, China

Status

Address

Fudan University

Shanghai, Shanghai, 200433

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