Hierarchical Diagnosis for Adult Diffuse Glioma Based on Deep Learning

Recruiting

• Conditions: Astrocytoma; Glioblastoma Multiforme; Oligodendroglioma
• Interventions: Diagnostic Test: multi-parametric magnetic resonance imaging scan; Diagnostic Test: Pathology examination

• Registration Number: NCT05624736
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief 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.

Detailed 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

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-11-13
• Study Start: 2022-11-20
• Study First Submitted QC: 2022-11-21
• Last Update Submitted: 2022-11-21
• Study First Posted: 2022-11-22
• Last Update Posted: 2022-11-22
• Primary Completion: 2023-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Glioblastoma Group	Pathology examination	Patients with the diagnosis of Glioblastoma based on 2021 WHO central nervous system tumor guideline.
Astrocytoma Group	Pathology examination	Patients with the diagnosis of Astrocytoma based on 2021 WHO central nervous system tumor guideline.
Astrocytoma Group	multi-parametric magnetic resonance imaging scan	Patients with the diagnosis of Astrocytoma based on 2021 WHO central nervous system tumor guideline.
Glioblastoma Group	multi-parametric magnetic resonance imaging scan	Patients with the diagnosis of Glioblastoma based on 2021 WHO central nervous system tumor guideline.
Oligodendroglioma Group	multi-parametric magnetic resonance imaging scan	Patients with the diagnosis of Oligodengroglioma based on 2021 WHO central nervous system tumor guideline.
Oligodendroglioma Group	Pathology examination	Patients with the diagnosis of Oligodengroglioma based on 2021 WHO central nervous system tumor guideline.

Primary Outcome Measures

Name	Time	Method
Tumor Grade	up to 2 weeks	Tumor Grade based on 2021 WHO central nervous system tumor guideline
Tumor Histologic diagnosis	up to 2 weeks	Tumor histologic diagnosis based on 2021 WHO central nervous system tumor guideline
Tumor genotype	up to 2 weeks	Tumor genotype based on 2021 WHO central nervous system tumor guideline

Trial Locations

Locations (1)

Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China