Hierarchical Diagnosis for Adult Diffuse Glioma Based on Deep Learning

Glioblastoma Multiforme Clinical Trial

Official title:

Artificial Intelligence Research of Hierarchical Diagnosis for Adult Diffuse Glioma Based on Deep Learning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05624736
• Other study ID #: 2022-LCYJ-MS-25
• Status: Recruiting
• Start date: November 20, 2022
• Est. completion date: May 1, 2025

Study information

• Verified date: July 2022
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Xin Zhang, Master
• Phone: 13814066403
• Email: zhangxin[@]njglyy.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Astrocytoma
• Glioblastoma
• Glioblastoma Multiforme
• Oligodendroglioma

Intervention

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

Locations

Country	Name	City	State
China	Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Grade	Tumor Grade based on 2021 WHO central nervous system tumor guideline	up to 2 weeks
Primary	Tumor Histologic diagnosis	Tumor histologic diagnosis based on 2021 WHO central nervous system tumor guideline	up to 2 weeks
Primary	Tumor genotype	Tumor genotype based on 2021 WHO central nervous system tumor guideline	up to 2 weeks