Artificial Intelligence (AI) Cytopathology Trial

The University of Texas System (UT)

Status: Enrolling

Conditions: Pancreatic Solid Lesions

Treatments: Other: Artificial Intelligence software ROSE

Study type: Observational

Funder types: Other

Identifiers

NCT05018663

HSC-MS-21-0051

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Prospective enrollment

Description:

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.

Treatment:

Other: Artificial Intelligence software ROSE