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临床试验/NCT06675266
NCT06675266招募中不适用

Development of an Artificial Intelligence Algorithm to Recognize Abnormal Findings at Routine Fetal Brain Ultrasound. AIRFRAME (Artificial Intelligence for Recognition of Fetal bRain AnoMaliEs)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2023年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
AI algorithm

研究概览

简要总结

Obstetric ultrasound represents the standard of care for the screening of the fetal anomalies. However, its performance is dependent upon several parameters including type of anomaly, gestational age, maternal habitus and skills of the examiner. The use of Artificial Intelligence (AI) in medical diagnostics has been suggested not only to reduce the inter- and intra-operator variability, but also to compress the required time necessary to perform routine tasks, hence optimizing healthcare resources. Fetal brain abnormalities are among the most challenging fetal congenital anomalies in terms of ultrasound diagnosis, prenatal counseling and management. The access to new sources of technology, i.e. AI, has the potential to improve recognition, detection and localization of brain malformations. Therefore, we propose to develop an AI-based software, which would be capable to recognize the brain structures at antenatal ultrasound and discriminate between normal and abnormal fetal brain anatomy through fully automatic data processing.

详细描述

The application of AI in obstetric ultrasound includes three aspects: structure identification, automatic and standardized measurements, and classification diagnosis. Since obstetric ultrasound is time-consuming, the use of AI could also reduce examination time and improve workflow.

Study design: this is a multicenter retrospective observational cohort study and subsequent prospective cohort study. The study design will be organized in two different phases.

The first phase, the feasibility retrospective study, has the objective to develop and train AI-Algorithm with normal and abnormal images retrospectively acquired during second trimester ultrasound scan from various international fetal medicine centers.

The second phase, a prospective clinical validation, has the objective to test the AI-Algorithm in the assessment of basic fetal brain anatomy in a real clinic setting with real patients from each of the participating fetal medicine centers.

Setting: Three (3) fetal medicine centers.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with singleton pregnancies undergoing ultrasound examination between 19+0 - 22+6 weeks of gestation

排除标准

  • Women who did not have the second trimester screening scan at the settled gestational age.
  • Women in which a good visualization of the transventricular, transthalamic and transcerebellar plane of the fetal head was not technically possible.
  • Women who are not able to give the informed consent.

结局指标

主要结局

AI algorithm

时间窗: 2 years

Number of cases detected with AI algorithm application

次要结局

  • Reproducibility(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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