Actively Recruiting

Age: 18Years +
All Genders
ID07228689

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

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)

Long-term Monitoring

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

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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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