AI for Onsite Cytology Evaluation in Endoscopic Ultrasound

NCT07228689 | Active Not Recruiting

• 1 other identifier: 2343877
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Neoplasm; Mass Lesion

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic adequacy at rapid onsite evaluation

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

  1 day

Secondary Outcomes (1)

• Diagnostic accuracy at rapid onsite evaluation

  7 days

Study Arms (2)

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

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

Interventions

EUS-guided fine needle biopsy DIAGNOSTIC_TEST

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

Interpretation of cytology specimen by artificial intelligence; Interpretation of cytology specimen by cytopathologist onsite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Orlando Health, Inc.: lead

Study Sites (1)

Orlando Health Digestive Health Institute

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Ji Young Bang, MD MPH

  Orlando Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: November 17, 2025
• Primary Completion: April 6, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

US (1)