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Contrastive study of 3D Cube sequence and conventional 2D sequence in magnetic resonance imaging of shoulder joint
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注册号:

Registration number:

ChiCTR2000033300 

最近更新日期:

Date of Last Refreshed on:

2020-05-27 

注册时间:

Date of Registration:

2020-05-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

肩关节磁共振成像3D Cube序列与常规2D序列对比研究  

Public title:

Contrastive study of 3D Cube sequence and conventional 2D sequence in magnetic resonance imaging of shoulder joint 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

肩关节磁共振成像3D Cube序列与常规2D序列对比研究 

Scientific title:

Contrastive study of 3D Cube sequence and conventional 2D sequence in magnetic resonance imaging of shoulder joint 

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:

陈晓飞 

研究负责人:

汪新柱 

Applicant:

Chen Xiaofei 

Study leader:

Wang Xinzhu 

申请注册联系人电话:

Applicant telephone:

+86 18119496201 

研究负责人电话:

Study leader's telephone:

+86 18919923711 

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:

cxf750915@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

cxf750915@sina.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:

兰州市七里河区瓜洲路418号 

研究负责人通讯地址:

兰州市七里河区瓜洲路418号 

Applicant address:

418 Guazhou Road, Qilihe District, Lanzhou, Gansu 

Study leader's address:

418 Guazhou Road, Qilihe District, Lanzhou, Gansu 

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:

甘肃省中医院 

Applicant's institution:

Gansu Provincial Hospital of Traditional Chinese Medicine 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2020-046-01 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

甘肃省中医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Gansu Hospital of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-22 

伦理委员会联系人:

米登海 

Contact Name of the ethic committee:

Mi Denghai 

伦理委员会联系地址:

兰州市七里河区瓜洲路418号 

Contact Address of the ethic committee:

418 Guazhou Road, Qilihe District, Lanzhou, Gansu 

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:

甘肃省中医院 

Primary sponsor:

Gansu Provincial Hospital of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

兰州市七里河区瓜洲路418号 

Primary sponsor's address:

418 Guazhou Road, Qilihe District, Lanzhou, Gansu 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

甘肃

市(区县):

兰州

Country:

China

Province:

Gansu

City:

Lanzhou

单位(医院):

甘肃省中医院

具体地址:

七里河区瓜洲路418号

Institution
hospital:

Gansu Provincial Hospital of Traditional Chinese Medicine

Address:

418 Guazhou Road, Qilihe District

经费或物资来源:

自筹 

Source(s) of funding:

self-raised 

研究疾病:

肩袖损伤 

Target disease:

Rotator cuff injury 

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:

探索性研究/预试验 

Study phase:

研究目的:

比较一种新型的三维并行成像及扩展超长回波链快速自旋回波采集序列(3D Cube序列)与常规二维序列(2D FSE序列) 的图像质量及诊断价值,为肩关节损伤的快速、精准诊断提供一种新的检查方法。 

Objectives of Study:

The image quality and diagnostic value of a new 3D parallel imaging and extended super-long echo chain rapid spin echo acquisition sequence (3D Cube sequence) were compared with the conventional 2D FSE sequence (2D FSE sequence) to provide a new examination method for the rapid and accurate diagnosis of shoulder joint injury. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

年龄18-48岁;以肩关节外伤、慢性疼痛或肩关节活动受限等来就诊;临床诊断为肩关节损伤并行肩关节镜检查治疗。 

Inclusion criteria

(1) Aged 18-48 years; (2) The patient was diagnosed with shoulder joint trauma, chronic pain or limited shoulder joint movement. (3) The clinical diagnosis was shoulder joint injury and shoulder arthroscopy. 

排除标准:

①有肩关节特殊劳动史,比如羽毛球/网球运动员等人员; ②既往有肩关节外伤或手术史; ③患者有神经刺激器、心脏起搏器、动脉瘤夹、内耳植入、心脏人工金属瓣膜、眼内金属异物、金属假体、铁磁性异物; ④重度高热、癫痫患者、幽闭恐怖症患者; ⑤孕妇; ⑥肩关节有严重畸形、肩关节无法制动或制动时间小于40分钟; ⑦扫描图像没有达到诊断标准。 

Exclusion criteria:

(1) Shoulder joint special labor history, such as badminton/tennis players and other personnel; (2) Previous shoulder trauma or surgery history; (3) Patients have nerve stimulator, cardiac pacemaker, aneurysm clip, inner ear implant, heart artificial metal valve, intraocular metal foreign body, metal prosthesis, ferromagnetic foreign body; (4) Severe fever, epilepsy patients, claustrophobia patients; (5) Pregnant women or the desire to become pregnant in the next year; (6) Shoulder joint has a serious deformity, shoulder joint brake time less than 40 minutes; (7) Scan images do not meet the diagnostic criteria for cases. 

研究实施时间:

Study execute time:

From2020-06-01To 2021-06-01 

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):

肩关节镜

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):

Arthroscopic shoulder

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):

肩关节磁共振成像3D Cube序列与常规2D序列

Index test:

3D Cube sequence and conventional 2D sequence in magnetic resonance imaging of shoulder joint

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)

肩袖损伤或疑似肩袖损伤患者

例数:

Sample size:

30

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 rotator cuff injury

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):

健康志愿者

例数:

Sample size:

20

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

healthy volunteers

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

甘肃 

市(区县):

兰州 

Country:

China 

Province:

Gansu 

City:

Lanzhou 

单位(医院):

甘肃省中医院 

单位级别:

三级甲等 

Institution
hospital:

Gansu Provincial Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

信噪比

指标类型:

主要指标 

Outcome:

Signal Noise Ratio

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

对比噪声比

指标类型:

主要指标 

Outcome:

Contrast to Noise Ratio

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

信号强度

指标类型:

主要指标 

Outcome:

signal strength(SI)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

标准偏差

指标类型:

主要指标 

Outcome:

standard deviation (SD)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

一致性

指标类型:

主要指标 

Outcome:

Consistency

Type:

Primary indicator 

测量时间点:

测量方法:

Kappa值

Measure time point of outcome:

Measure method:

Kappa value

指标中文名:

SEN, SPE, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SEN, SPE, ACC, AUC of ROC

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:

无人体标本

组织:

Sample Name:

No human specimens.

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

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 48 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):

未使用

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

Not used

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

论文形式发表

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

According to the research progress, the project team chooses a specific way to release the raw data

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:

使用病例记录表采集和管理数据

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

Collect and manage data using case records

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-05-27
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