Artificial Intelligence (AI) Cytopathology Trial

Conditions

• Pancreatic Solid Lesions

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Artificial Intelligence software ROSE — OTHER
  Rapid on-site evaluation (ROSE) of Endoscopic Ultrasound (EUS) guided FNA/FNB (Fine Needle Aspirate/Fine Needle Biopsy) of pancreatic solid lesions (PSLs) has been shown in improve diagnostic yield. The availability and performance of ROSE at EUS performing centers is variable. With strides in Artificial Intelligence (AI) capabilities over the years, the University of Texas at Health Sciences Center at Houston in collaboration with Haystac is developing an artificial intelligence based proprietary system to analyze slides from EUS FNA/FNB samples at bedside.

Study Details

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.

Key Dates

Start date

Jul 21, 2021

Status verified

Feb 2023

Primary completion

Jul 31, 2024

Completion

Jan 30, 2028

Study Design

Enrollment

50 participants (estimated)

Arms

• Arm: Prospective enrollment
  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 Measure

Detection the adequacy for diagnosis [ Time Frame: During procedure ]

Central Contacts

• Prithvi B Patil, MS
  7135006456
  [email protected]

Locations (1)

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