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AI for Onsite Cytology Evaluation in Endoscopic Ultrasound

Artificial Intelligence for Onsite Cytology Evaluation in Endoscopic Ultrasound

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07228689
Enrollment
136
Registered
2025-11-14
Start date
2025-11-17
Completion date
2026-12-01
Last updated
2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Neoplasm, Mass Lesion

Keywords

endoscopic ultrasound, solid mass lesion, artificial intelligence, fine needle biopsy

Brief summary

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.

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.

Interventions

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

Sponsors

Orlando Health, Inc.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic adequacy at rapid onsite evaluation1 dayThe ability of the AI systems to interpret specimen adequacy on cytology images

Secondary

MeasureTime frameDescription
Diagnostic accuracy at rapid onsite evaluation7 daysThe ability of the AI systems to interpret and diagnose cytology images

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJi Young Bang, MD MPH

Orlando Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026