Diagnostic Efficiency of Artificial Intelligence for Surgical Neuropathology

NCT ID: NCT04671368

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-28

Study Completion Date

2022-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a multi-center, prospective, self-controlled, diagnostic accuracy comparative study of Artificial Intelligence Diagnostic System for Surgical Neuropathology. The investigators will compare the diagnostic efficiency of Artificial Intelligence with that of practicing pathologists, and suppose that the diagnostic efficiency of artificial intelligence in prospective clinical data is no less than that of pathologists.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this study, 141 patients will be recruited. After being enrolled, the patients will accept surgery and specimens for pathological analysis will be taken according to the routine treatment process.

The histopathologic slides will then be digitized by a whole-slide scanner. The images will be reviewed by gold standard committee for evaluation of ground truth. And then be separately diagnosed by Artificial Intelligence Diagnostic System and practicing pathologists. So the investigators can compare the diagnostic efficiency of Artificial Intelligence with that of pathologists, thus understand the gap between artificial intelligence and actual clinical practice.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Central Nervous System Neoplasms

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Artificial Intelligence CNS Tumor Surgical Pathology Diagnostic Accuracy Study

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

All patients will be diagnosed by both AI and ordinary pathologists, thus performing a self-controlled study
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
The AI group, ordinary pathologists and gold standard group will not be informed of each other's results

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Artificial Intelligence

A deep learning based artificial intelligence diagnostic system(DOI:10.1093/neuonc/noaa163)

Group Type EXPERIMENTAL

Artificial Intelligence

Intervention Type DIAGNOSTIC_TEST

The investigators will use the Artificial Intelligence Diagnostic System to review the H&E stained slide of each patient and then report the classification of the tumor on a 10-type scale.

Practicing Pathologists

One pathologist who has at least 5 years of experience

Group Type ACTIVE_COMPARATOR

Practicing Pathologists

Intervention Type DIAGNOSTIC_TEST

The ordinary pathologist will review the H&E stained slide of each patient(without additional informations such as: Immunohistochemistry et al.) and then report the classification of the tumor on a 10-type scale only bases on the slide images

Gold Standard

A committee composed of two expert pathologists who has at least 10 years of experience and one expert pathologist who has at least 15 years of experience

Group Type OTHER

Gold Standard

Intervention Type DIAGNOSTIC_TEST

Firstly, the two expert pathologist(\>=10 years of experience) will review the H&E stained slide of each patient on their own (with additional informations such as: Immunohistochemistry et al.) and then report the classification of the tumor on a 10-type scale.If they report the same opinion, that opinion will perform as the ground truth; while if their opinion clash with each other, the expert pathologist(\>=15 years of experience) will get involved and the agreement of three experts will perform as the ground truth

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Artificial Intelligence

The investigators will use the Artificial Intelligence Diagnostic System to review the H&E stained slide of each patient and then report the classification of the tumor on a 10-type scale.

Intervention Type DIAGNOSTIC_TEST

Practicing Pathologists

The ordinary pathologist will review the H&E stained slide of each patient(without additional informations such as: Immunohistochemistry et al.) and then report the classification of the tumor on a 10-type scale only bases on the slide images

Intervention Type DIAGNOSTIC_TEST

Gold Standard

Firstly, the two expert pathologist(\>=10 years of experience) will review the H&E stained slide of each patient on their own (with additional informations such as: Immunohistochemistry et al.) and then report the classification of the tumor on a 10-type scale.If they report the same opinion, that opinion will perform as the ground truth; while if their opinion clash with each other, the expert pathologist(\>=15 years of experience) will get involved and the agreement of three experts will perform as the ground truth

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients or their guardians understand the research process, agree to use their data, and sign the informed consent form;
2. Aged \>=18 years;
3. MRI shows intracranial spaceoccupying lesions;
4. The clinical diagnosis is glioma, metastasis or lymphoma thus requiring surgical treatment;
5. The patient is willing to accept the surgery.

Exclusion Criteria

1. The patient has serious underlying diseases thus is not suitable for surgery;
2. After further clinical evaluation, surgical treatment was not the best choice;
3. The patient participate in clinical research of other drugs or devices;
4. The researchers believe that there are other factors that will make the patients unable to complete the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jinsong Wu

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jinsong Wu

Chief Physician of Neurosurgery Department, Vice-director of Neurosurgery Institute, Member of Ethics Committee, Clinical Professor of Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cuiyun Wu, Ph.D

Role: STUDY_DIRECTOR

Huashan Hospital

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lei Jin, DR

Role: CONTACT

Phone: 0086-13817841756

Email: [email protected]

Yixin Ma, BA

Role: CONTACT

Phone: 0086-18001781531

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PAAI2020

Identifier Type: -

Identifier Source: org_study_id