Gastric Cancer
Conditions
Keywords
artificial intelligence, gastric cancer
Brief summary
Title: A single-center, retrospective randomized controlled trial of artificial intelligence (AI) versus expert endoscopists for diagnosis of gastric cancer in patients who underwent upper gastrointestinal endoscopy. Précis: this single-center, retrospective randomized controlled trial will include 500 outpatients who underwent upper gastrointestinal endoscopy for gastric cancer screening and will compare the diagnostic detection rate for gastric cancer of AI and expert endoscopists. Objectives Primary Objective: to evaluate the diagnostic detection rate for gastric cancer of AI and expert endoscopists. Secondary Objectives: to determine whether AI is not inferior to expert endoscopists in terms of the number of images analyzed for diagnosis of gastric cancer and intersection over union (IOU), and the detection rate of diagnosis of early and advanced gastric cancer. Endpoints Primary Endpoint: diagnosis of gastric cancer. Secondary Endpoints: image based diagnosis of gastric cancer and IOU. Population: in total, 500 males and females aged ≥ 20 years who underwent upper gastrointestinal endoscopy for screening of gastric cancer at a single hospital in Japan. Describe the Intervention: AI-based diagnosis of gastric cancer based on upper gastrointestinal endoscopy images. Study Duration: 3 months.
Detailed description
Prior to Study: Total 500: Screen potential subjects by inclusion and exclusion criteria; obtain endoscopy images. Randomization was performed. Intervention: AI diagnosis was performed for 250 patients using upper gastrointestinal endoscopy images, and Expert endoscopists diagnosis was performed for 250 patients by same methods. Primary analysis: Perform primary analysis of primary and secondary endpoints for 250 patients in each group Cross over diagnosis between AI and expert endoscopists was performed. Perform secondary analysis of agreement of gastric cancer diagnosis per images and IOU between AI and expert endoscopists for 500 patients.
Interventions
DIAGNOSTIC_TESTAI-based diagnosis
AI-based diagnosis will be performed based on analysis of endoscopic images (Olympus Optical, Tokyo, Japan). The investigators will use the Single Shot MultiBox Detector (SSD), a deep neural network architecture (https://arxiv.org/abs/1512.02325), and an optimal diagnostic cutoff from a prior report2. The AI system reviewed endoscopy images and reported those in which gastric cancer was detected, together with the coordinates (X, Y) of the lesions.
DIAGNOSTIC_TESTThe expert endoscopists-based diagnosis
The expert endoscopists are two physicians with experience of more than 20,000 endoscopies. The expert endoscopists will review the endoscopy images of each patient for 5 min. They will then report endoscopy images in which gastric cancer was detected and manually annotate the lesions in those images.
Sponsors
Tokyo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males or females aged ≥ 20 years who underwent upper gastrointestinal endoscopy at Tokyo University Hospital during 2018. 2. Informed optout consent, obtained from each patient before completion of the study.
Exclusion criteria
1. Patients who underwent gastrectomy. 2. Patients who underwent transnasal upper gastrointestinal endoscopy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Per patient diagnosis of gastric cancer | Up to 6 weeks from study start | Number of Participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intersection over union (IOU) of gastric lesions | Up to 6 weeks from study start | A value between 0 and 1 |
| Diagnosis of advanced gastric cancer | Up to 6 weeks from study start | Number of Participants diagnosed with advanced gastric cancer |
| Diagnosis of early gastric cancer | Up to 6 weeks from study start | Number of Participants diagnosed with early gastric cancer |
| Agreement on image and IOU based diagnosis of gastric cancer between AI and expert endoscopists | Up to 12 weeks from study start | Number of images and IOU value (between 0 and 1) |
| Number of images analyzed for diagnosis of gastric cancer | Up to 6 weeks from study start | Number of upper gastrointestinal endoscopy images |
Countries
Japan
Outcome results
None listed