AI using endoscopic ultrasound and white-light endoscopy to diagnose upper GI mesenchymal tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational project combines retrospective image datasets for training and validation with prospectively recruited cases for independent testing. High-quality endoscopic ultrasound (EUS) images, white-light endoscopy (WLE) images, and clinical data are collected under strict quality-control criteria. A multimodal AI model integrates these inputs via a multi-branch fusion strategy and is compared to expert endoscopists using cross-validation on prospectively gathered data. The primary comparisons are diagnostic classification of subepithelial lesions and risk stratification of gastric GISTs, with performance measured against histopathological reference standards.

Why it matters

Who can join: the full rules

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

Where it's running

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Bin Cheng
• Email: b.cheng@tjh.tjmu.edu.cn
• Phone: +8613986097542

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• GIST Patient Registry for real-world insights

  This registry collects medical information from people with GIST to see how the disease behaves in real life and to help improve care.

  Recruiting The Life Raft Group · Wayne, New Jersey · NCT07697248

• ctDNA-guided precision care for lung, GIST, colorectal, biliary, and ovarian cancers

  This trial tests a blood test that looks for tumor DNA in patients with several cancers to help guide personalized treatment decisions.

  Recruiting Royal Marsden NHS Foundation Trust · London · NCT07673861

• Elix Cycle Balance and Elix Daily Harmony for fibroid-related symptoms

  This 24-week virtual study will test whether taking the herbal supplements Elix Cycle Balance and Elix Daily Harmony daily can reduce menstrual pain and other fibroid-related symptoms in women aged 20–45 with uterine fibroids.

  Recruiting Zenchi, Inc. · Las Vegas, Nevada · NCT07078682

• International registry for very rare childhood tumors

  This project will collect detailed medical information to see how clinical and biological features affect outcomes in children and adolescents with very rare tumors.

  Recruiting Azienda Ospedaliera di Padova · Padova, Italy · NCT07072143

• Combining ziftomenib and imatinib for advanced gastrointestinal stromal tumors

  This study is testing whether combining two medications, ziftomenib and imatinib, can help adults with advanced gastrointestinal stromal tumors who haven't responded well to imatinib alone.

  Recruiting at 32 sites Phase 1 Kura Oncology, Inc. · Birmingham, Alabama and 31 other locations · NCT06655246

• Evaluating DCC-3009 for treating gastrointestinal stromal tumors

  This study is testing a new treatment called DCC-3009 for people with gastrointestinal stromal tumors to see if it is safe and effective, either on its own or with other cancer therapies.

  Recruiting at 10 sites Phase 1/2 Deciphera Pharmaceuticals, LLC · Scottsdate, Arizona and 9 other locations · NCT06630234

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.