Artificial Intelligence (AI) Cytopathology Trial

NCT05018663 | Recruiting

• 1 other identifier: HSC-MS-21-0051
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Solid Lesions

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Detection the adequacy for diagnosis

  The primary outcome of the study is to determine how AI compares with ROSE in determining if EUS FNA/FNB sample from PSLs is adequate for diagnosis. This will be interpreted as a percentage in each group. The main study parameter is on-site determination if an EUS FNA/FNB sample is adequate for interpretation and diagnosis

  During procedure

Secondary Outcomes (1)

• Comparing the accuracy between preliminary diagnosis

  During procedure

Study Arms (1)

Prospective enrollment

All subjects will be enrolled prospectively. Subjects will be included in the study after eligibility is assessed and informed consent is obtained. The slide scanner will scan the slides on site and the images will be securely saved and sent for interpretation by the AI software at a different location. The results of the AI interpretation of the slides will be blinded to the on-site procedure team including the endoscopist and cytopathologist until the final pathology report is complete.

Other: Artificial Intelligence software ROSE

Interventions

Artificial Intelligence software ROSE 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.

Prospective enrollment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from the inpatients and outpatients departments of the participating hospital and will be included in the study. A consent will be obtained for the EUS FNA/FNB per standard of care.

You may qualify if:

• Have EUS finding of a PSL;
• Do not have contraindications for FNA/FNB.

You may not qualify if:

• Inability to provide informed consent for the procedure;
• Contraindication for FNA/FNB eg coagulopathy, lack of avascular window for FNA.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Nirav Thosani, MD, MHA

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prithvi B Patil, MS

CONTACT

7135006456; prithvi.b.patil@uth.tmc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 24, 2021
• Study Start: July 21, 2021
• Primary Completion: July 31, 2024
• Study Completion (Estimated): January 30, 2028
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

US (1)