Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Location status: Recruiting
Recruiting
NCT Number: NCT06718725
An Artificial Intelligence System for ROSE of 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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- the patient age ≥18 years accepted EUS-FNA+ROSE.
- agree to participate in the research and be able to sign written informed consent.
Exclusion criteria
- uncorrectable coagulopathy (PTT >50 seconds or INR >1.5) and/or uncorrectable thrombocytopenia (platelet count <50 × 109 /L).
- patients who were too clinically ill to undergo an EUS examination.
- lesions that were deemed inaccessible for EUS-guided sampling.
- unsuccessful EUS-FNA (e.g., failure to obtain an adequate specimen, patient intolerance, intraoperative accidents, etc.).
- Patients with unqualified ROSE smear.
- Patients who underwent biopsy during EUS-FNA but did not receive a definitive pathological diagnosis or pathological report.
- pregnancy.
Treatment and study plan
ROSE-AI system
Diagnostic TestThe cytopathological slide images of the patients' ROSE samples will be identified by the ROSE-AI system.
Primary outcomes
-
the accuracy, sensitivity and specificity of the ROSE-AI system in identifying malignant/non-malignant ROSE samples
Time frame: During procedure
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.
Secondary outcomes
-
comparing the diagnostic performance between endoscopists with ROSE-AI system and without ROSE-AI system
Time frame: During procedure
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Qilu Hospital of Shandong University
Other
Collaborators
- 960th Hospital of PLA
- Binzhou Medical University
- Binzhou People's Hospital
- Liaocheng People's Hospital
- Qilu Hospital of Shandong University (Qingdao)
- Shandong Provincial Hospital
- Taian City Central Hospital
- The Affiliated Hospital of Qingdao University
- Yidu Central Hospital of Weifang
Registry information
Official study title
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.
Acronym: ROSE，EUS-FNA
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Dec 5, 2024
- Registry last updated
- Dec 5, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.