RECRUITING

Artificial Intelligence (AI) Cytopathology Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-07-21
Study Completion:2028-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05018663

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have EUS finding of a PSL;
  2. * Do not have contraindications for FNA/FNB.
  1. * Inability to provide informed consent for the procedure;
  2. * Contraindication for FNA/FNB eg coagulopathy, lack of avascular window for FNA.

Contacts and Locations

Study Contact

Prithvi B Patil, MS
CONTACT
7135006456
prithvi.b.patil@uth.tmc.edu

Principal Investigator

Nirav Thosani, MD, MHA
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

Memorial Hermann Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Nirav Thosani, MD, MHA, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-21
Study Completion Date2028-01-30

Study Record Updates

Study Start Date2021-07-21
Study Completion Date2028-01-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Pancreatic Solid Lesions