Today is 2019-12-12

Study for artificial intelligence accurate diagnosis of liver tumors with contrast enhanced ultrasound images
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注册号:

Registration number:

ChiCTR1900027599 

最近更新日期:

Date of Last Refreshed on:

2019-11-20 

注册时间:

Date of Registration:

2019-11-20 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

用于精确诊断肝脏占位超声造影人工智能的研究 

Public title:

Study for artificial intelligence accurate diagnosis of liver tumors with contrast enhanced ultrasound images 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

用于精确诊断肝脏占位超声造影人工智能的研究 

Scientific title:

Study for artificial intelligence accurate diagnosis of liver tumors with contrast enhanced ultrasound images 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

刘灯 

研究负责人:

郭燕丽 

Applicant:

Liu Deng 

Study leader:

Guo Yanli 

申请注册联系人电话:

Applicant telephone:

+86 18716435873 

研究负责人电话:

Study leader's telephone:

+86 13608351873 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

1093710804@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

guoyanli71@aliyun.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

重庆市沙坪坝区高滩岩正街30号 

研究负责人通讯地址:

重庆市沙坪坝区高滩岩正街30号 

Applicant address:

30 Gao-Tan-Yan Main Street, Shapingba District, Chongqiang, China 

Study leader's address:

30 Gao-Tan-Yan Main Street, Shapingba District, Chongqiang, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

陆军军医大学第一附属医院 

Applicant's institution:

The First Affiliated Hospital of Army Medical University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

陆军军医大学第一附属医院 

Primary sponsor:

The First Affiliated Hospital of Army Medical University 

研究实施负责(组长)单位地址:

重庆市沙坪坝区高滩岩正街30号 

Primary sponsor's address:

30 Gao-Tan-Yan Main Street, Shapingba District, Chongqiang, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

陆军军医大学第一附属医院

具体地址:

重庆市沙坪坝区高滩岩正街30号

Institution
hospital:

The First Affiliated Hospital of Army Medical University

Address:

30 Gao-Tan-Yan Main Street, Shapingba District, Chongqiang, China

经费或物资来源:

陆军军医大学第一附属医院重大领域技术创新项目 

Source(s) of funding:

The Major Field Technical Innovation Program Project of the First Affiliated Hospital of Army Medical University 

研究疾病:

肝脏疾病 

Target disease:

Liver tumors 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本课题将人工智能技术应用于肝脏肿瘤的超声造影领域,利用AI技术对超声造影图像进行自动识别,定位肿瘤的位置、提取肿瘤的超声影像特征,并结合相关病史和其他影像学数据综合分析,辅助诊断肝脏肿瘤的性质和类型,减少不必要的漏诊和误诊,增强肝脏肿瘤超声造影的诊断准确性。实现精准医疗,更好的服务于临床和患者。 

Objectives of Study:

Artificial intelligence is excellent performance in image-recognition tasks, and we will use it to recognized contrast-enhanced ultrasound images of liver tumors. In this project, we will utilize deep learning algorithms, which integrates quantitative contrast-enhanced ultrasound images features, clinical factors, and pathologic information, to build an artificial intelligence diagnosis assistant method for benign and malignant tumors preoperative prediction. The aim is to make more accurate image diagnosis and also provide better service for clinical.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1.患者年龄大于18岁 2.无超声造影剂过敏史 3.超声发现肝脏占位,有完整的二维超声、彩色多普勒血流显像和频谱多普勒和超声造影图像记录 4.患者有完整肝功能、乙肝、肿瘤标志物和血常规检查记录 5.患者拟进行手术或肝脏穿刺,能获得确切的病理结果 

Inclusion criteria

1. Patients aged <=18 years old; 2. Patients without allergic history of contrast enhanced ultrasound; 3. Patients with ultrasound, color Doppler, spectral Doppler and contrast enhanced ultrasound images; 4. Patients with the examination of Hepatic function, hepatitis B, tumor marker and blood routine examination; 5. Accept surgery or liver biopsy to obtain conclusive histopathological information. 

排除标准:

1.没有明确病理结果,或是病理结果有疑问的病例 

Exclusion criteria:

Patients without conclusive histopathology or have doubt with histopathology.  

研究实施时间:

Study execute time:

From2019-08-01To 2020-12-31 

诊断措施:

Diagnostic measures:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

病理检查

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Histopathologic examinations

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

智能影像辅助诊断方法

Index test:

Artificial intelligent diagnosis assistant method

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

可行手术或穿刺的肝肿瘤患者

例数:

Sample size:

1297

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Patients with surgically or liver biopsy confirmed liver tumors

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

陆军军医大学第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of Army Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

超声造影时间强度曲线

指标类型:

主要指标 

Outcome:

Time-intensity curve of contrast enhanced ultrasound

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

病例标本

组织:

肝脏

Sample Name:

Pathology sample

Tissue:

Liver

人体标本去向

使用后销毁 

说明

在医院病理科保存,保存年限由病理科决定

Fate of sample:

Destruction after use 

Note:

Stored in the department of pathology(time of preservation at the discretion of the pathologists)

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 90 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

N/A

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

未说明

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

联系项目负责人;ResMan

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Contact applicant;ResMan

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

电子采集和管理系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-11-20
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