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临床试验/NCT05790473
NCT05790473招募中不适用

Artificial Intelligence Algorithm for the Screening of Abnormal Fetal Brain Findings at First Trimester Ultrasound Scan

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5月1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

Visualization of the posterior fossa brain spaces, their spatial relationship and measurements can be obtained in the midsagittal view of fetal head, the same used for NT measurement (9), and plays an important role in the early diagnosis of neural tube defects, such as open spinal dysraphism (5), and posterior fossa anomalies, such as DWM or BPC (7). However, assessment of the fetal posterior fossa in the first trimester is still challenging due to several limitations including involuntary movements of the fetus and small size of the brain structures, causing difficulties for examination and misdiagnosis. Moreover, it is also operator-dependent for the acquirement of high-quality ultrasound images, standard measurements, and precise diagnosis.

The use of new technologies to improve the acquisition of images, to help automatically perform measurements, or aid in the diagnosis of fetal abnormalities, may be of great importance for the optimal assessment of the fetal brain, particularly in the first trimester (10). Artificial intelligence (AI) is described as the ability of a computer program to perform processes associated with human intelligence, such as learning, thinking and problem-solving. Deep Learning (DL), a subset of Machine Learning (ML), is a branch of AI, defined by the ability to learn features automatically from data without human intervention. In DL, the input and output are connected by multiple layers loosely modeled on the neural pathways of the human brain. In the image recognition field, one of the most promising type of DL networks is represented by convolutional neural networks (CNN). These are designed to extract highly representative image features in a fully automated way, which makes them applicable to diagnostic decision-making.

According to these observations, we propose a research project aimed to develop an ultrasound-based AI-algorithm, which is capable to assess the fetal posterior fossa structures during the first trimester ultrasound scan and discriminate between normal and abnormal findings through a 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 first trimester ultrasound scan from ten international fetal medicine centers.

The second phase, a prospective clinical validation, has the objective to test the AI-Algorithm in the assessment of the fetal posterior fossa 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
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with single pregnancies who underwent ultrasound examination between 11+0 - 13+6 weeks of gestation or a fetal crown-rump-length between 45 - 84 mm.

排除标准

  • Women who did not have the first trimester screening scan at the settled gestational age.
  • Women in which a good visualization of the mid-sagittal view 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
Principal Investigator
主要研究者

Familiari Alessandra

Clinician

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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