AI for Onsite Cytology Evaluation in Endoscopic Ultrasound

November 13, 2025 updated by: Orlando Health, Inc.

Artificial Intelligence 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients aged 18 years or greater, undergoing EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Interpretation of cytology specimen by cytopathologist onsite
The interpretation of the cytology specimens will be made onsite by the cytopathologist
Diagnostic test: EUS-guided fine needle biopsy
EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract
Interpretation of cytology specimen by artificial intelligence
The interpretation of the cytology specimens will be made onsite by the AI program
Diagnostic test: EUS-guided fine needle biopsy
EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy at rapid onsite evaluation
Time Frame: 1 day
The ability of the AI system to correctly interpret cytology images, compared to cytopathologists.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy compared to final pathology
Time Frame: 7 days
The ability of the AI system to corrently interpret cytology images, compared to final pathology results.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orlando Health, Inc.

Investigators

  • Principal Investigator: Ji Young Bang, MD MPH, Orlando Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Estimated)

November 14, 2025

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

November 13, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2343877

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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