Clinical trial NCT04671368: Diagnostic Efficiency of Artificial Intelligence for Surgical Neuropathology
Official title: A Multi-center, Prospective, Self-Controlled Diagnostic Accuracy Comparative Studies of Artificial Intelligence Diagnostic System for Surgical Neuropathology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Nervous System Neoplasms
Keywords: Artificial Intelligence
CNS Tumor
Surgical Pathology
Diagnostic Accuracy Study
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients will be diagnosed by both AI and ordinary pathologists, thus performing a self-controlled study
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic Accuracy of Study Arms
timeFrame: 1 week after the last patient's diagnosis is completed
Secondary outcomes:
measure: Sensitivity and specificity of Study Arms
timeFrame: 1 week after the last patient's diagnosis is completed
measure: Spearman Coefficient of Study Arms related to Gold Standard
timeFrame: 1 week after the last patient's diagnosis is completed
Other outcomes:
Locations:
Study officials:
affiliation: Huashan Hospital
name: Cuiyun Wu, Ph.D
role: STUDY_DIRECTOR
References: