跳至主要内容
临床试验/NCT04654546
NCT04654546招募中不适用

A Prospective Study for the Conversion of Ultrasound Images to CT Format Imaging Using Artificial Intelligence-based Learning

HaEmek Medical Center, Israel2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年8月24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
50
试验地点
2
主要终点
Normalized cross-correlation between input CT images and the ultrasound-based algorithm-generated CT images

研究概览

简要总结

Background: Ultrasound imaging is an imaging method that uses sound waves to characterize the structure and function of various organs in health and disease conditions. This technique is widely used in clinical day-to-day life and has many advantages, such as real-time imaging, availability for imaging at the patient's bedside, and lack of ionizing radiation. Aside from the mentioned advantages, the ultrasound test also has notable drawbacks. These include the absence of sound wave penetration through a medium containing air such as intestinal loops, dependence on operator skill, and the need for the subject's cooperation during the test. Compared to the ultrasound examination, the CT scan allows for a broader anatomical view and is not limited by physiological factors such as bones and air. on the other hand, the test requires ionizing radiation that inevitably carries a direct and indirect danger to the patient's health, and requires more financial resources.

Objectives of the study: Using artificial intelligence to bridge the gap between ultrasound and CT scans, and to create a uniform system that takes advantage of them. This is to allow for better spatial orientation as well as a better characterization of the anatomical structures being scanned.

Participants: Women and/or men over the age of 18, who performed an abdominal CT scan during the previous month for the ultrasound examination in the experiment.

Methods: The study is a prospective open-label research, in which both the physician and the patient are aware of the manner and purposes of the scan. Participants who meet the threshold conditions will be summoned for examination in the rooms of the Imaging Institute at Haemek medical center, during which the participants will undergo a complete ultrasound scan of the abdominal organs using a clinical ultrasound device. The ultrasound images will be visually coupled to previous CT images of the same patient at the time of the examination, using a Fusion system located in the ultrasound device mentioned above. The conjugated CT and ultrasound images will be encoded and will be sent without identifying details to the SAMPL laboratory, to be used as a learning platform for the artificial intelligence system. The images will be transferred after the subject's personal details have been encoded in an EXCEL file and saved by the principal investigator.

详细描述

Background and rationale of the medical experiment:

Ultrasound imaging is an imaging method that uses sound waves to characterize the structure and function of various organs in health and disease conditions. This technique is widely used in clinical daily life and has many benefits. The exam does not involve the use of ionizing radiation, so its use is safer than other techniques such as X-rays or CT scans (Computed Tomography). The images acquired and viewed on the ultrasound device are real-time, so changes can be identified, which in many cases affects the final diagnosis. The test is non-invasive, nor does the test require the use of a contrast agent that contains substances that may cause an allergic reaction or impair kidney function. In addition, the equipment is widely available, and can also be used bedside. Aside from the mentioned advantages, the ultrasound test also has notable drawbacks. The ultrasound waves do not penetrate well through bones or air, thus impairing test quality. In addition, the method is highly dependent on the skill of the operator, so substantial experience is required in order to produce sufficient quality information and make an accurate diagnosis. The quality of the test also depends on the cooperation of the subject during the test, such as changes in posture and deep breathing.

Compared to the ultrasound examination, the CT scan allows for a broader anatomical view, and is not limited by physiological factors such as bones and air. The most notable shortcomings of the CT scan include the fact that the test requires ionizing radiation that inevitably carries a direct and indirect danger to the patient's health. In addition, the test requires more resources financially and in terms of manpower, which is a limitation in its use outside the hospital or in countries with poor socio-economic status.

In this study, the investigators aim to bridge the gap between these two types of techniques and create a uniform system that takes advantage of both. This is done by creating CT images from ultrasound images. This process will involve the use of artificial intelligence methods, namely machine learning algorithms.

Machine learning in general, and deep learning in particular, have gained momentum in recent years in the field of computer vision and more recently also in the field of medical imaging. In addition, one can already see significant successes in the classification of retinal diseases, in which the sensor is a fundus camera or Optical Coherence Tomography (OCT), in the classification of classifications In MRI imaging of the breast 3, and more recently, in the classification of the severity of the disease caused by the Corona virus, using chest X-rays and ultrasound scans.

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

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

入选标准

  • Participants who performed an abdominal CT exam up to one month prior to the experimental ultrasound exam.

排除标准

  • Participants who had a change in their medical condition that may have substantial effects on the imaging features of the abdominal organs.
  • Pregnant women

结局指标

主要结局

Normalized cross-correlation between input CT images and the ultrasound-based algorithm-generated CT images

时间窗: 2 year

The cross-correlation between the input CT images, serving as Ground Truth, and the algorithm-generated CT images will serve as a measure of similarity (Similarity score), normalized to a range \[-1,1\].

Accuracy rate

时间窗: 2 year

System accuracy rate will be evaluated by comparing the aforementioned similarity score to a success rate threshold (T).

次要结局

未报告次要终点

研究者

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

Israel Aharoni

Radiology resident, Haemek medical center Radiology institute, Principal investigator.

HaEmek Medical Center, Israel

研究点 (2)

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