跳至主要内容
临床试验/NCT07228689
NCT07228689进行中(未招募)不适用

Artificial Intelligence for Onsite Cytology Evaluation in Endoscopic Ultrasound

Orlando Health, Inc.2 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2025年11月17日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
136
试验地点
2
主要终点
Diagnostic accuracy at rapid onsite evaluation

研究概览

简要总结

The aim of this study is to determine if the widely available artificial intelligence platform ChatGPT can accurately identify the abnormalities present on cytology specimens obtained at EUS-FNB of solid mass lesions in the gastrointestinal tract, in comparison with interpretation by cytopathologists as the gold standard.

详细描述

The diagnostic accuracy of EUS-guided fine needle biopsy of lesions in the gastrointestinal tract is dependent on the availability of a cytopathologist to render a rapid on-site evaluation (ROSE), with studies showing that the presence of an on-site cytopathologist improves the diagnostic yield, decreases the number of inadequate or unsatisfactory samples, and limits the number of passes required to establish a diagnosis. However, the availability of ROSE is variable across centers and regions, with the availability of onsite cytopathology services limited to a handful of tertiary referral centers in the United States.

ChatGPT is a universally available, generative artificial intelligence program developed by OpenAI. The aim of this study is to determine if this AI platform can accurately identify the abnormalities present on cytology specimens obtained at EUS-FNB of solid mass lesions in the gastrointestinal tract, in comparison with interpretation by cytopathologists as the gold standard.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years old or greater
  • Patients undergoing EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract

排除标准

  • Age less than 18 years
  • Patients not undergoing sampling of solid mass lesions at EUS
  • Patients with cystic lesions in the gastrointestinal tract

研究组 & 干预措施

Interpretation of cytology specimen by cytopathologist onsite

The interpretation of the cytology specimens will be made onsite by the cytopathologist

干预措施: EUS-guided fine needle biopsy (Diagnostic Test)

Interpretation of cytology specimen by artificial intelligence

The interpretation of the cytology specimens will be made onsite by the AI program

干预措施: EUS-guided fine needle biopsy (Diagnostic Test)

结局指标

主要结局

Diagnostic accuracy at rapid onsite evaluation

时间窗: 1 day

The ability of the AI system to correctly interpret cytology images, compared to cytopathologists.

Diagnostic adequacy at rapid onsite evaluation

时间窗: 1 day

The ability of the AI systems to interpret specimen adequacy on cytology images

次要结局

  • Diagnostic accuracy compared to final pathology(7 days)
  • Diagnostic accuracy at rapid onsite evaluation(7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验