Hierarchical Diagnosis for Adult Diffuse Glioma Based on Deep Learning

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05624736
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 29.3
• Patients Per Site Per Month: 17

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Astrocytoma; Glioblastoma Multiforme; Oligodendroglioma	Diagnostic Test: multi-parametric magnetic resonance imaging scan; Diagnostic Test: Pathology examination

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 Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Case-Crossover
• Time Perspective: Retrospective
• Official Title: Artificial Intelligence Research of Hierarchical Diagnosis for Adult Diffuse Glioma Based on Deep Learning
• Anticipated Study Start Date: Nov 20, 2022
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Glioblastoma Group Patients with the diagnosis of Glioblastoma based on 2021 WHO central nervous system tumor guideline.	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
Astrocytoma Group Patients with the diagnosis of Astrocytoma based on 2021 WHO central nervous system tumor guideline.	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
Oligodendroglioma Group Patients with the diagnosis of Oligodengroglioma based on 2021 WHO central nervous system tumor guideline.	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

Outcome Measures

Primary Outcome Measures

1. Tumor Grade [up to 2 weeks]

   Tumor Grade based on 2021 WHO central nervous system tumor guideline

2. Tumor Histologic diagnosis [up to 2 weeks]

   Tumor histologic diagnosis based on 2021 WHO central nervous system tumor guideline

3. Tumor genotype [up to 2 weeks]

   Tumor genotype based on 2021 WHO central nervous system tumor guideline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu	China	210093

Sponsors and Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• ClinicalTrials.gov Identifier: NCT05624736
• Other Study ID Numbers: 2022-LCYJ-MS-25
• First Posted: Nov 22, 2022
• Last Update Posted: Nov 22, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: Astrocytoma; Glioblastoma; Oligodendroglioma; deep learning; artificial intelligence
• Additional relevant MeSH terms: Glioblastoma; Astrocytoma; Oligodendroglioma

Study Results

No Results Posted as of Nov 22, 2022