Multicenter Observational Study of a Multimodal AI Model Using EUS, White-Light Endoscopy, and Clinical Data for Diagnosis of Upper GI Mesenchymal Tumors and Risk Stratification of Gastric GISTs

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

This study develops a multimodal AI model using endoscopic ultrasound, white-light endoscopy, and clinical information to support the diagnosis of upper GI mesenchymal tumors and the risk stratification of gastric GISTs.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years old

• Patients with an upper gastrointestinal subepithelial lesion (SEL) identified by white-light endoscopy and who have completed an endoscopic ultrasound (EUS) examination

• Patients with a histopathological diagnosis of GIST confirmed by surgical or endoscopic resection, or other SELs confirmed by surgical resection, EUS-guided sampling, or other biopsy techniques

• EUS image quality meets the following quality control standards

‣ Equipment requirements: Olympus EU-ME2/ME1 processor (Olympus Medical Systems Corp., Tokyo, Japan); radial EUS scope (GF-UE260/GF-UE240; Olympus, Tokyo, Japan) or linear EUS scope (GF-UCT260/GF-UCT240; Olympus, Tokyo, Japan); miniature probe (UM2R/3R; Olympus, Tokyo, Japan); Pentax ARIETTA 850 processor (Pentax, Tokyo, Japan); radial EUS scope (EG-3670URK, Pentax, Tokyo, Japan); linear EUS scope (EG-3870UT, Pentax, Tokyo, Japan); Fujifilm SU-8000 or SU-9000 processor; linear EUS scope (EG-580UT, Fujifilm, Tokyo, Japan); radial EUS scope (EG-580UR, Fujifilm, Tokyo, Japan)

⁃ EUS images clearly showing the lesion and surrounding tissue characteristics (at least 5 images or video); must include at least one image of the maximum lesion diameter, one image showing the layer of origin, and one image demonstrating the growth pattern (intraluminal/extraluminal)

⁃ EUS images must not contain artificial annotations, such as measurement scales, biopsy needles, Doppler signals, or elastography overlays

⁃ Image resolution must be at least 448 × 448 pixels

• WLE (white-light endoscopy) image quality meets the following standards: images must clearly show the lesion location, mucosal features, and margins; at least one close-up and one distant view

• Complete clinical data and histopathological reports must be available

Locations
Other Locations
China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Bin Cheng
b.cheng@tjh.tjmu.edu.cn
+8613986097542
Time Frame
Start Date: 2025-07-28
Estimated Completion Date: 2026-06
Participants
Target number of participants: 130
Treatments
All Participants
All enrolled patients with upper gastrointestinal subepithelial lesions confirmed by histopathology. Each participant will undergo standard diagnostic evaluation and independent multimodal AI prediction and expert endoscopist diagnosis.
Sponsors
Leads: Huazhong University of Science and Technology

This content was sourced from clinicaltrials.gov