Recruiting

AI

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT05018663

Conditions

Pancreatic Solid Lesions

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Artificial Intelligence software ROSE

Study Details

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.

Conditions

Pancreatic Solid Lesions

Study ID

NCT05018663

Start date

Jul 21, 2021

Status verified date

Feb, 2023

Completion date

Jan 30, 2028

Anticipated

Primary completion date

Jul 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Artificial Intelligence software ROSE

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Prithvi B Patil, MS

7135006456prithvi.b.patil@uth.tmc.edu

Locations

Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Prithvi B Patil

713-480-1179prithvi.b.patil@uth.tmc.edu

Prithvi Patil, MS

7135006456prithvi.b.patil@uth.tmc.edu

Principal Investigator:

Nirav Thosani, MD,MHA

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Feb 16, 2023

Last verified

Feb, 2023

Keywords

  • Endoscopic Ultrasound guided fine needle aspiration (FNA)
  • Endoscopic Ultrasound guided fine needle biopsy (FNB)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2023-02-16.