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Hierarchical Diagnosis for Adult Diffuse Glioma Based on Deep Learning

Study Purpose

This is a restrospective study to establish a deep learning model based on multi-parametric magnetic resonance imaging scans to predict Grade, histopathologic type and genotype of adult diffuse Glioma.

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
Eligible Ages	18 Years - 90 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients undergoing surgery in Nanjing DrumTower Hospital between 2010.01 and 2022.05 with post-surgery pathological diagnosis of WHO Grade II to IV Adult Diffuse Glioma. 2. Available pre-surgery T1WI, T2WI, T1CE, FLARI and DWI MR sequences. 3. No pre-surgery anti-tumor therapy.

Exclusion Criteria:

1. Poor image quality. 2. Failed image preprocessing. 3. Unavailable pathology data

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.	NCT05624736
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.	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Astrocytoma, Glioblastoma Multiforme, Oligodendroglioma

Additional Details

Glioma is a common kind of tumor in central nervous system. The pre-operative prediction of grade, histopathologic type and genotype is important for treatment and management of Adult diffuse Glioma patients. Right now, most of the diagnostic prediction models on glioma are based on 2016 WHO central nervous system tumor guideline. The goal of this study is to establish a new deep learning model to predict Grade, histopathologic type and genotype of adult diffuse Glioma. We will recruit 500 patients with pathologically confirmed diagnosis of Glioblastoma, Astrocytoma and Oligodendroglioma who received neurologic surgery in our center. Each subject underwent pre-operative multi-parametric magnetic resonance imaging scans including T1WI, T2WI, T1CE, FLAIR and DWI. Pathologic diagnosis of each patient are available in pathology department. A deep learning based hierarchical diagnosis

Arms & Interventions

Arms

: Glioblastoma Group

Patients with the diagnosis of Glioblastoma based on 2021 WHO central nervous system tumor guideline.

: Astrocytoma Group

Patients with the diagnosis of Astrocytoma based on 2021 WHO central nervous system tumor guideline.

: Oligodendroglioma Group

Patients with the diagnosis of Oligodengroglioma based on 2021 WHO central nervous system tumor guideline.

Interventions

Diagnostic Test: - multi-parametric magnetic resonance imaging scan

Pre-operative multi-parametric magnetic resonance imaging scans including T1WI, T2WI, T1CE, FLAIR and DWI were taken for clinical needs.

Diagnostic Test: - Pathology examination

The tumor specimen obtained from the surgery were sent to the pathology department for histopathologic examination, immunohistochemistry and gene sequencing test

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.

International Sites

Nanjing, Jiangsu, China

Status

Recruiting

Address

Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, 210093

Site Contact

Xin Zhang, Master

[email protected]

13814066403

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