An Artificial Intelligence System for ROSE of EUS-FNA Sample: a Prospective, Multicenter, Diagnostic Study. (ROSE，EUS-FNA)

An Artificial Intelligence System for Rapid Onsite Cytologic Pathology Evaluation（ROSE） of Endoscopic Ultrasound-guided Fine-needle Aspiration (EUS-FNA) Sample: a Prospective, Multicenter, Diagnostic Study.

This is an observational study with a prospective, multicenter, disgnostic design. An artificial intelligence system named ROSE-AI system was developed using cytopathological slide images taken by microscope camera or smartphone of pancreas, bile duct, liver and lymph node, collected retrospectively from patients who underwent EUS-FNA and ROSE, and the performance of ROSE-AI system was validated in the datasets collected prospectively.This study aims to assist endoscopists in conducting rapid on-site cytopathology evaluations during EUS-FNA without the presence of cytopathologists. In addition, the diagnostic field was compared between the cytopathologists and ROSE-AI system, endoscopists with or without ROSE-AI system.

Study Overview

• Status: Recruiting
• Conditions: The Malignant Lesions and Non-malignant Lesions of Pancreas, Bile Duct, Liver and Lymph Node
• Intervention / Treatment: Diagnostic test: ROSE-AI system

• Study Type: Observational
• Enrollment (Estimated): 236

Contacts and Locations

• Study Contact: Name: Zhen Li; Phone Number: 18560086106; Email: qilulizhen@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with pancreatic, bile duct, hepatic, or lymph node lesions undergoing EUS-FNA and ROSE from the participating hospitals.

Description

Inclusion Criteria:

1. the patient age ≥18 years accepted EUS-FNA+ROSE.
2. agree to participate in the research and be able to sign written informed consent.

Exclusion Criteria:

1. uncorrectable coagulopathy (PTT >50 seconds or INR >1.5) and/or uncorrectable thrombocytopenia (platelet count <50 × 109 /L).
2. patients who were too clinically ill to undergo an EUS examination.
3. lesions that were deemed inaccessible for EUS-guided sampling.
4. unsuccessful EUS-FNA (e.g., failure to obtain an adequate specimen, patient intolerance, intraoperative accidents, etc.).
5. Patients with unqualified ROSE smear.
6. Patients who underwent biopsy during EUS-FNA but did not receive a definitive pathological diagnosis or pathological report.
7. pregnancy.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing EUS-FNA and ROSE; Patients ≥18 years with pancreatic, bile duct, hepatic, or lymph node lesions accepted EUS-FNA and ROSE.	Diagnostic test: ROSE-AI system; The cytopathological slide images of the patients' ROSE samples will be identified by the ROSE-AI system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the accuracy, sensitivity and specificity of the ROSE-AI system in identifying malignant/non-malignant ROSE samples	The primary outcome of the study is to evaluate the performance of the ROSE-AI system in identifying the malignant/non-malignant ROSE samples of pancreatic, bile duct, hepatic and lymph node based on both images taken by microscope camera and smartphone, and comparing the performance between the ROSE-AI system and endoscopists, cytopathologists.	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparing the diagnostic performance between endoscopists with ROSE-AI system and without ROSE-AI system	A cross-over human-AI contest using images of the prospective testing dataset will be performed. The diagnostic performance of endoscopists with ROSE-AI system and without ROSE-AI system will be evaluated.	During procedure

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Collaborators: The Affiliated Hospital of Qingdao University; Shandong Provincial Hospital; Liaocheng People's Hospital; Taian City Central Hospital; Binzhou People's Hospital; Qilu Hospital of Shandong University (Qingdao); Binzhou Medical University; Yidu Central Hospital of Weifang; 960th Hospital of PLA

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Estimated): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024SDU-QILU-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No