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NCT Number: NCT07228689

AI for Onsite Cytology Evaluation in Endoscopic Ultrasound

The aim of this study is to determine if the widely available artificial intelligence platform ChatGPT can accurately identify the abnormalities present on cytology specimens obtained at EUS-FNB of solid mass lesions in the gastrointestinal tract, in comparison with interpretation by cytopathologists as the gold standard.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Gastrointestinal Neoplasm Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Mass Lesion Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orlando Health Digestive Health Institute

Orlando, Florida, 32806, United States

About this study

The diagnostic accuracy of EUS-guided fine needle biopsy of lesions in the gastrointestinal tract is dependent on the availability of a cytopathologist to render a rapid on-site evaluation (ROSE), with studies showing that the presence of an on-site cytopathologist improves the diagnostic yield, decreases the number of inadequate or unsatisfactory samples, and limits the number of passes required to establish a diagnosis. However, the availability of ROSE is variable across centers and regions, with the availability of onsite cytopathology services limited to a handful of tertiary referral centers in the United States.

ChatGPT is a universally available, generative artificial intelligence program developed by OpenAI. The aim of this study is to determine if this AI platform can accurately identify the abnormalities present on cytology specimens obtained at EUS-FNB of solid mass lesions in the gastrointestinal tract, in comparison with interpretation by cytopathologists as the gold standard.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years old or greater
  • Patients undergoing EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract

Exclusion criteria

  • Age less than 18 years
  • Patients not undergoing sampling of solid mass lesions at EUS
  • Patients with cystic lesions in the gastrointestinal tract

Treatment and study plan

EUS-guided fine needle biopsy

Diagnostic Test

EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract

Primary outcomes

  1. Diagnostic adequacy at rapid onsite evaluation

    Time frame: 1 day

    The ability of the AI systems to interpret specimen adequacy on cytology images

Secondary outcomes

  1. Diagnostic accuracy at rapid onsite evaluation

    Time frame: 7 days

    The ability of the AI systems to interpret and diagnose cytology images

Sponsors and collaborators

Lead sponsor

Orlando Health, Inc.

Other

Registry information

Official study title

Artificial Intelligence for Onsite Cytology Evaluation in Endoscopic Ultrasound

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 14, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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