Clinical trial Recruiting at 1 site Observational Ages 18 to 100

Comparing AI and traditional methods for analyzing pancreatic lesions

Official title: 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

Run by The University of Texas Health Science Center, Houston · NCT05018663 · Data updated 2026-11-12

This study is testing if using artificial intelligence to analyze pancreatic tissue samples can give accurate results compared to having a doctor look at them right away.

Quick facts

Study typeObservational
Ages18 Years to 100 Years
SexAll
Enrollment50 (estimated)
SponsorThe University of Texas Health Science Center, Houston
Academic / other
Locations1 site (Houston, Texas)
StatusRecruiting
StartedJuly 21, 2021
Main results expectedJuly 31, 2024
Study endsJanuary 30, 2028
Registry record updatedFebruary 16, 2023
Trial IDNCT05018663 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with endoscopic ultrasound findings of pancreatic solid lesions who can safely undergo FNA or FNB.

Probably not a fit

Patients who cannot provide informed consent or have contraindications for FNA/FNB will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of artificial intelligence (AI) in interpreting samples obtained from endoscopic ultrasound-guided fine needle aspiration (FNA) and biopsy (FNB) of pancreatic solid lesions. It will compare the adequacy of sample interpretation between real-time on-site evaluation (ROSE) by a cytopathologist and AI analysis at the bedside. Patients will undergo standard procedures for sample collection, with slides being prepared for both human and AI analysis. The study seeks to determine the accuracy of preliminary diagnoses made using these two methods against final pathology reports.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy and efficiency of diagnosing pancreatic lesions, leading to better patient outcomes.

How similar studies have gone: While the use of AI in cytopathology is an emerging field, this specific comparison of AI and ROSE in pancreatic lesions is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Memorial Hermann Hospital
    Houston, Texas, United States
    Recruiting

Study contacts

  • Principal investigator: Nirav Thosani, MD, MHA — The University of Texas Health Science Center, Houston
  • Study coordinator: Prithvi B Patil, MS
  • Email: prithvi.b.patil@uth.tmc.edu
  • Phone: 7135006456

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.