NCT05018663 Artificial Intelligence (AI) Cytopathology Trial
| NCT ID | NCT05018663 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Pancreatic Solid Lesions |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-07-21 |
| Primary Completion | 2024-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2021-07-21 with a primary completion date of 2024-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Nirav Thosani, MD, MHA
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT05018663 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Pancreatic Solid Lesions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05018663 currently recruiting?
Yes, NCT05018663 is actively recruiting participants. Contact the research team at prithvi.b.patil@uth.tmc.edu for enrollment information.
Where is the NCT05018663 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05018663 clinical trial?
NCT05018663 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Nirav Thosani, MD, MHA at The University of Texas Health Science Center, Houston. The trial plans to enroll 50 participants.