Trials / Recruiting
RecruitingNCT07228689
AI for Onsite Cytology Evaluation in Endoscopic Ultrasound
Artificial Intelligence for Onsite Cytology Evaluation in Endoscopic Ultrasound
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Orlando Health, Inc. · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | EUS-guided fine needle biopsy | EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract |
Timeline
- Start date
- 2025-11-12
- Primary completion
- 2026-12-01
- Completion
- 2027-10-01
- First posted
- 2025-11-14
- Last updated
- 2025-11-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07228689. Inclusion in this directory is not an endorsement.