Artificial Intelligence Neuropathologist

Sponsor
Huashan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05300113
Collaborator
United Imaging Healthcare (Other)
1,000
1
31
32.2

Study Details

Study Description

Brief Summary

CNS tumor requires biopsy for pathological diagnosis, which is known as the "golden standard". We would like to achieve automated classification of brain tumors based on deep learning in digital histopathology images and molecular pathology results. We expect to develop an assistant system (including software and hardware), to help pathologists during their diagnosis for CNS tumor.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aim of the study is to develop an automated pathological diagnosis system for CNS tumors based on deep learning technique. It is designed to firstly develop the best deep learning model for pathological diagnosis of CNS tumors, in order to improve the accuracy of pathological diagnosis. Then to be used clinically, reduce the workload and stress of neuropathologists and obtain the benefits for CNS tumor patients.

    Different CNS tumors including meningioma, glioma, lymphoma and other various tumors have their own different treatment principles and plans. For example, high grade glioma requires operational resection and post-operational chemo-radiotherapy. However, operational resection is not significant for improving prognosis in lymphoma patients, systematic chemotherapy will be performed after specific diagnosis based on biopsy. Therefore, in this study, an automated CNS tumor pathological diagnosis system will be developed to classify the different type of those tumors.

    At present, pathological diagnosis of CNS tumors is based on histopathological characteristics and molecular information after a systematic analyzed by pathologists. The accuracy of the diagnosis very much relies on the experience of the pathologists. However, to become a experienced and qualified pathologist requires years of training. Pathologists may give completely different diagnose outcome for the same patient. Thus, it is essential to develop a system that can assist pathologists.

    Deep learning is one of the most advanced techniques of artificial intelligence. In particular, the ability of image recognition is extremely powerful. Therefore, we are able to develop a model for histopathological section images based on deep learning. WHO Classification of CNS Tumors 2016 has included molecular markers as the important part of diagnosis. Hence, there will be an additional model of molecular pathology to be added to the system.

    Huashan Hospital has one of the largest CNS tumor biobank in China, which is the key part for deep learning, as it needs large amount of data. The case load of this study is able to show the representative and authoritative of those data.

    There will be three stages of the study. Stage 1 and 2 are supervised learning process. Stage 1 is to develop the best deep learning model for histopathological diagnosis of CNS tumors, we anticipate the accuracy for the first model to achieve at least 70%. The training data (pathological sections) will be provided by Huashan Hospital CNS tumor biobank. In the mean time, a micro-positioning platform is under investigation for the use of image collection. At the end of stage 1, we anticipate to integrate the model (software) and the platform (hardware) as the whole diagnose system for histopathological images. Stage 2 is to design a model for molecular pathological diagnosis for CNS tumors. The model will be trained by numerous amount of related molecular information extracted from those pathological sections. At the end of stage 2, we anticipate to combine stage 1 system and stage 2 model as the primary prototype. Stage 3 is known as the unsupervised learning process. By using the prototype developed after previous stages, the system will be used clinically. With the incoming of more patients and data, together with pathologists in the hospital, it will give its diagnosis. By comparing the results with pathologists, it will be able to self-learn and improve the accuracy as the time goes on. By the end of stage 3, we anticipate to have the system ready for independent clinical pathological diagnosis ability with the accuracy greater than 90%.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Artificial Intelligence Neuropathologist - Automated CNS Tumor Pathological Diagnosis Based on Deep Learning
    Anticipated Study Start Date :
    May 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    CNS Tumor

    All patients age from 18-75 years with CNS tumors are included and count as one group

    Outcome Measures

    Primary Outcome Measures

    1. Automated histopathological diagnosis outcome (software development) [Nov,2018 - Nov,2019]

      After supervised training, the software of the histopathological diagnosis of CNS tumor achieve at least 70% accuracy

    2. Positioning platform for microscope (hardware development) [Nov,2018 - Nov,2019]

      Hardware investigation for pathology section image collection, to automatically scan the section images.

    3. Combine automated molecular pathological diagnosis [Nov,2019 - Jun,2020]

      Molecular information being added to the histopathological diagnosis regarding to WHO 2016 CNS Tumor guide. Combine histopathology and molecular to give final diagnosis

    Secondary Outcome Measures

    1. Unsupervised training with more cases to improve the system [Nov,2019 - Nov,2022]

      Improve diagnosis accuracy of the system by continuous collection with a large number of CNS tumor cases from Huashan Hospital, which can be done without supervision.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    The participants diagnosed with brain cancer by diagnosis of WHO 2016 classification of CNS tumors.

    Exclusion Criteria:

    Voluntarily quit

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hushan Hospital, Fudan University Shanghai Shanghai China 200040

    Sponsors and Collaborators

    • Huashan Hospital
    • United Imaging Healthcare

    Investigators

    • Study Chair: Jinsong Wu, Ph.D. & M.D, Huashan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jinsong Wu, Professor, Huashan Hospital
    ClinicalTrials.gov Identifier:
    NCT05300113
    Other Study ID Numbers:
    • KY2017-340
    First Posted:
    Mar 29, 2022
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jinsong Wu, Professor, Huashan Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 29, 2022