跳至主要内容
临床试验/NCT06306599
NCT06306599已完成不适用

Human-AI Collaboration for Ultrasound Diagnosis of Thyroid Nodules - a Clinical Trial

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Accuracy of S-Detect diagnosis

研究概览

简要总结

This is an experimental study wherein groups of medical students and physicians of varying degrees of experience in head-and-neck ultrasound were asked to scan the same five patients each with a thyroid nodule.

The study participants did their own ultrasound assessment of the thyroid nodules, as well as using an AI-based ultrasound diagnostics system.

The researchers intended to study two primary outcomes: 1) how varying degrees of experience in ultrasound by the operator might affect the diagnostic performance of the AI-based system, and 2) how the AI-based system influenced the diagnostic performance of the ultrasound operator.

详细描述

This is a prospective clinical study aiming to test how the experience of the ultrasound operator influences the performance of AI-based (artificial intelligence-based) diagnostics when analysing thyroid nodules on ultrasound scans. The investigators set up an experiment with five stations, each with a patient with a thyroid nodule and an ultrasound machine with the deep learning based system S-Detect for Thyroid installed. 20 study participants where recruited: 8 medical students of novice ultrasound skill, 3 junior ENT (ear-nose-throat) registrars of intermediate ultrasound skill, and 9 senior ENT registrars experienced in ultrasound. The participants scanned all the patients and recorded their analyses of the nodules using the EUTIRADS (European thyroid imagining reporting and data system) system in three different ways: a analysis of their own, S-Detect's analysis, and an analysis combining the two previous.

The hypothesis was that the AI system would perform equally well when between the participant groups. In addition, it was expected that the experienced participants would perform better than the students without AI help, and that the doctors would gain little from AI input, but that the students would have their performance improved by AI input.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Medical students
  • •Inclusion Criteria:
  • •Last year student

排除标准

  • •Experience with ultrasound beyond that which is taught at the University of Copenhagen
  • •Junior ENT registrar doctors
  • •Inclusion Criteria:
  • •Doctor enrolled in introductory training as ENT physician.
  • •Senior ENT registrar doctors
  • •Inclusion Criteria:
  • •Doctor enrolled in ENT training.

研究组 & 干预措施

Experiment

Experimental

20 participants ultrasound scan five patients with thyroid nodules, and assess these nodules themselves, then with the AI-program, and at last they give a combined assessment.

干预措施: S-Detect for Thyroid (Diagnostic Test)

结局指标

主要结局

Accuracy of S-Detect diagnosis

时间窗: 1 day (day of experiment)

Number of correct thyroid nodule malignancy diagnoses out of total malignancy diagnoses by the AI-based ultrasound diagnostic system "S-Detect" on the five patients' thyroid nodules. Gold standard is cytology and histology of the nodules.

次要结局

  • Accuracy of biopsy recommendation(1 day (day of experiment))
  • Nodule measurement(1 day (day of experiment))
  • OSAUS score(1 day (day of experiment))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Axel Bukhave Edström

Principal Investigator

Rigshospitalet, Denmark

研究点 (1)

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