What this study is
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.
What's being tested
- Artificial Intelligence software ROSE
Intervention · 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
- 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
- Sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Pancreatic Solid Lesions
- Enrolling
- 50 people
- Starts
- 2021-07-21
- Est. completion
- 2028-01-30
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 100 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Have EUS finding of a PSL;
- Do not have contraindications for FNA/FNB.
You can't join if
- Inability to provide informed consent for the procedure;
- Contraindication for FNA/FNB eg coagulopathy, lack of avascular window for FNA.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMemorial Hermann Hospital
Houston, Texas, United States
- Prithvi B Patil · Contact713-480-1179prithvi.b.patil@uth.tmc.edu
- Prithvi Patil, MS · Contact7135006456prithvi.b.patil@uth.tmc.edu
- Nirav Thosani, MD,MHA · Principal investigator
Recruiting
Study team
Sponsor
The University of Texas Health Science Center, Houston
Study ID HSC-MS-21-0051
Principal investigator
Nirav Thosani, MD, MHA
The University of Texas Health Science Center, Houston
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.