Actively Recruiting
Artificial Intelligence for Onsite Cytology Evaluation in Endoscopic Ultrasound
Led by Orlando Health, Inc. · Updated on 2025-11-14
200
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether the widely available artificial intelligence platform ChatGPT can accurately identify abnormalities on cytology specimens taken during endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) of solid mass lesions in the gastrointestinal tract. The study compares AI interpretations with those made by experienced cytopathologists, who are considered the gold standard. The research aims to address the limited availability of onsite cytopathology services that currently affect diagnostic accuracy and efficiency. The study involves the use of EUS-guided fine needle biopsy to collect cytology specimens from solid mass lesions in the gastrointestinal tract. There are two interpretation groups: one where cytopathologists review specimens onsite, and another where the AI program analyzes the samples. The study observes and compares diagnostic accuracy between these two methods without intervening in patient care. Participants will undergo the biopsy procedure, and their cytology specimens will be evaluated either by onsite cytopathologists or by the AI program. Researchers will measure the diagnostic accuracy at rapid onsite evaluation within one day and compare it to final pathology results obtained within seven days. The study is observational and will monitor these outcomes without additional treatment, lasting until October 2027.
CONDITIONS
Brief Title
AI for Onsite Cytology Evaluation in Endoscopic Ultrasound
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years old or greater
- Patients undergoing EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract
You will not qualify if you...
- Age less than 18
- Patients not undergoing sampling of solid mass lesions at EUS
- Patients with cystic lesions in the gastrointestinal tract
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo an endoscopic ultrasound-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract to collect cytology specimens for evaluation.
1 visit (in-person)
Duration - 7 days
Participants are monitored for diagnostic accuracy by comparing onsite cytology evaluation with final pathology results.
Trial Site Locations
Total: 1 location
1
Orlando Health Digestive Health Institute
Orlando, Florida, United States, 32806
Actively Recruiting
Research Team
J
Ji Young Bang, MD MPH
B
Barbara J Broome
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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