AI for Onsite Cytology Evaluation in Endoscopic Ultrasound
Artificial Intelligence for Onsite Cytology Evaluation in Endoscopic Ultrasound
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Florida
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Orlando, Florida, United States, 32806
- Orlando Health Digestive Health Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
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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
|
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 adequacy at rapid onsite evaluation
Time Frame: 1 day
|
The ability of the AI systems to interpret specimen adequacy on cytology images
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic accuracy at rapid onsite evaluation
Time Frame: 7 days
|
The ability of the AI systems to interpret and diagnose cytology images
|
7 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ji Young Bang, MD MPH, Orlando Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2343877
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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