AI for Onsite Cytology Evaluation in Endoscopic Ultrasound

Orlando Health, Inc.

Status: Enrolling

Conditions: Gastrointestinal Neoplasm; Mass Lesion

Treatments: Diagnostic Test: EUS-guided fine needle biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT07228689

2343877

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Interpretation of cytology specimen by cytopathologist onsite

Description:

The interpretation of the cytology specimens will be made onsite by the cytopathologist

Treatment:

Diagnostic Test: EUS-guided fine needle biopsy

Interpretation of cytology specimen by artificial intelligence

Description:

The interpretation of the cytology specimens will be made onsite by the AI program

Treatment:

Diagnostic Test: EUS-guided fine needle biopsy