Artificial Intelligence (AI) Cytopathology Trial

Description

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.

Conditions

Pancreatic Solid Lesions

Study Overview

Study Details

Study overview

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.

Artificial Intelligence for Rapid On-site Evaluation (AI-ROSE) for Endoscopic Ultrasound-guided Fine-needle Aspiration (EUS-FNA) Biopsy of Pancreatic Solid Lesions: A Prospective Double Blinded Study

Artificial Intelligence (AI) Cytopathology Trial

Condition
Pancreatic Solid Lesions
Intervention / Treatment

-

Contacts and Locations

Houston

Memorial Hermann Hospital, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Have EUS finding of a PSL;
  • * Do not have contraindications for FNA/FNB.
  • * Inability to provide informed consent for the procedure;
  • * Contraindication for FNA/FNB eg coagulopathy, lack of avascular window for FNA.

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Health Science Center, Houston,

Nirav Thosani, MD, MHA, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

2028-01-30