Artificial Intelligence (AI) Cytopathology Trial

Recruiting

• Conditions: Pancreatic Solid Lesions
• Interventions: Other: Artificial Intelligence software ROSE

• Registration Number: NCT05018663
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

Purpose The primary objective of the study is to compare interpretation of EUS FNA/FNB samples for adequacy between ROSE and AI at bedside. To compare accuracy of preliminary diagnosis results between ROSE and AI at bedside versus final pathology report.

Research design This is a prospective single center study to compare performance characteristics in the interpretation of EUS FNA/FNB samples between AI and ROSE.

Procedures to be used Eligible patients will undergo EUS guided FNA/FNA of PSLs using standard of care. Sample slides are prepared by a cytopathologist at bedside and observed under a microscope. At the same time, the slides are scanned using a slide scanner and those images are saved for interpretation by AI at a later time.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-21
• Study First Submitted: 2021-08-17
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-24
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-16
• Primary Completion: 2024-07-31
• Study Completion: 2028-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Have EUS finding of a PSL;
• Do not have contraindications for FNA/FNB.

Exclusion Criteria

• Inability to provide informed consent for the procedure;
• Contraindication for FNA/FNB eg coagulopathy, lack of avascular window for FNA.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective enrollment	Artificial Intelligence software ROSE	All subjects will be enrolled prospectively. Subjects will be included in the study after eligibility is assessed and informed consent is obtained. The slide scanner will scan the slides on site and the images will be securely saved and sent for interpretation by the AI software at a different location. The results of the AI interpretation of the slides will be blinded to the on-site procedure team including the endoscopist and cytopathologist until the final pathology report is complete.

Primary Outcome Measures

Name	Time	Method
Detection the adequacy for diagnosis	During procedure	The primary outcome of the study is to determine how AI compares with ROSE in determining if EUS FNA/FNB sample from PSLs is adequate for diagnosis. This will be interpreted as a percentage in each group. The main study parameter is on-site determination if an EUS FNA/FNB sample is adequate for interpretation and diagnosis

Secondary Outcome Measures

Name	Time	Method
Comparing the accuracy between preliminary diagnosis	During procedure	To compare the accuracy between AI and ROSE preliminary diagnosis versus the final pathology report.; Interpretation of preliminary results will be divided into categories of benign vs malignancy, acinar cells vs ductal cells in benign, adenocarcinoma vs neuroendocrine tumor vs other in malignancy.

Trial Locations

Locations (1)

Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States