Multicenter Observational Study of Multimodal AI for Upper GI Mesenchymal Tumor Diagnosis

Launched by HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Jul 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new computer program that uses artificial intelligence (AI) to help doctors better diagnose and understand certain types of tumors that grow in the upper part of the digestive system, like the stomach. These tumors, called mesenchymal tumors, include conditions such as gastrointestinal stromal tumors (GISTs), leiomyomas, and schwannomas. The AI tool looks at images from special scopes used during endoscopy procedures, along with clinical information, to assist in identifying the tumor type and assessing how risky a gastric GIST might be.

People who might be eligible for this study are adults aged 18 or older who have already had an upper gastrointestinal lesion found during a white-light endoscopy and have completed an endoscopic ultrasound (EUS) exam. Their tumor diagnosis needs to be confirmed through surgery, biopsy, or other medical tests, and the images from their exams must meet specific quality standards. Participants can expect that their existing medical images and information will be used to help develop and test this AI tool. It’s important to note this study is not yet recruiting, and people with certain health conditions, pregnancy, or poor-quality imaging won’t be eligible. This research aims to improve how doctors diagnose and manage these tumors using advanced technology, potentially leading to better care in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • 1. 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)
• • 2. 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)
• • 3. EUS images must not contain artificial annotations, such as measurement scales, biopsy needles, Doppler signals, or elastography overlays
• • 4. 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
• Exclusion Criteria:
• • Age \< 18 years old
• • Absolute contraindications for EUS examination, history of gastric surgery, pregnancy, severe comorbidities, or known allergy to anesthetic agents
• • EUS examination terminated prematurely due to esophageal stricture, obstruction, large space-occupying lesions, rapid changes in heart rate or respiratory rate, patient intolerance, or excessive residual food
• • EUS image quality does not meet the required quality control standards
• • Pathological specimens do not meet diagnostic requirements: insufficient biopsy tissue (only R0 resection specimens are accepted for the GIST group), or incomplete immunohistochemical staining (missing CD117/CD34/DOG-1 expression report for the GIST group)
• • Pathological results indicate that the lesion is a metastatic tumor originating from another site