Comparing AI and traditional methods for analyzing pancreatic lesions
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
The University of Texas Health Science Center, Houston · NCT05018663
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 type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05018663 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with endoscopic ultrasound findings of pancreatic solid lesions who can safely undergo FNA or FNB.
Not a fit: Patients who cannot provide informed consent or have contraindications for FNA/FNB will not benefit from this study.
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 performed: While the use of AI in cytopathology is an emerging field, this specific comparison of AI and ROSE in pancreatic lesions is relatively novel.
Eligibility criteria
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 this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Solid Lesions, Endoscopic Ultrasound guided fine needle aspiration, Endoscopic Ultrasound guided fine needle biopsy