中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600122373
最近更新日期： Date of Last Refreshed on：	2026-04-13 14:45:27
注册时间： Date of Registration：	2026-04-13 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	AI辅助压缩感知与并行采集在脑T1W-3D成像中的对比研究：图像质量与皮层测量的评估；ACS加速因子的合理选择
Public title：	A Comparative Study of AI-Assisted Compressed Sensing and Parallel Acquisition in Brain T1W-3D Imaging: Evaluation of Image Quality and Cortical Measurements
注册题目简写：	ACS超快速脑MRI技术在脑结构分析中的应用
English Acronym：	Application of ACS Ultra-Rapid Brain MRI Technology in Brain Structural Analysis
研究课题的正式科学名称：	AI压缩感知(ACS)优化的超快速脑MRI技术及其在精神疾病脑结构分析中的应用
Scientific title：	AI-Compressed Sensing (ACS)-Optimised Ultra-Rapid Brain MRI Technology and Its Application in Structural Analysis of Psychiatric Disorders
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：	姚刚	研究负责人：	姚刚
Applicant：	Gang Yao	Study leader：	Gang Yao
申请注册联系人电话： Applicant telephone：	+86 135 6784 3667	研究负责人电话： Study leader's telephone：	+86 135 6784 3667
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：	yaogang0303@126.com	研究负责人电子邮件： Study leader's E-mail：	yaogang0303@126.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：	宁波市镇海区庄市街道庄俞南路1号	研究负责人通讯地址：	宁波市镇海区庄市街道庄俞南路1号
Applicant address：	No. 1 Zhuangyun South Road, Zhuangshi Street, Zhenhai District, Ningbo City, Zhejiang Province, China	Study leader's address：	No. 1 Zhuangyun South Road, Zhuangshi Street, Zhenhai District, Ningbo City, Zhejiang Province, China
申请注册联系人邮政编码： Applicant postcode：	315201	研究负责人邮政编码： Study leader's postcode：	315201
申请人所在单位：	宁波大学附属康宁医院影像科,全省药物成瘾与脑健康重点实验室
Applicant's institution：	Department of Radiology, Zhejiang Key Laboratory of Drug Addiction & Brain Health,Affiliated Kangning Hospital of Ningbo University(Ningbo Kangning Hospital)
研究负责人所在单位：	宁波大学附属康宁医院
Affiliation of the Leader：	Affiliated Kangning Hospital of Ningbo University

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：	NBKNYY-2026-LC-10	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：	宁波大学附属康宁医院伦理委员会
Name of the ethic committee：	Ethics Committee of Kangning Hospital Affiliated to Ningbo University
伦理委员会批准日期： Date of approved by ethic committee：	2026-03-31 00:00:00
伦理委员会联系人：	黄敏芳
Contact Name of the ethic committee：	Huang Minfang
伦理委员会联系地址：	宁波市镇海区庄市街道庄俞南路1号
Contact Address of the ethic committee：	1 Zhuangyu South Road, Zhuangshi Subdistrict, Zhenhai District, Ningbo
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 574 2630 2565	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：

宁波大学附属康宁医院

Primary sponsor：

Affiliated Kangning Hospital of Ningbo University

研究实施负责（组长）单位地址：

中国浙江省宁波市镇海区庄市街道庄俞南路1号

Primary sponsor's address：

No. 1 Zhuangyun South Road, Zhuangshi Street, Zhenhai District, Ningbo City, Zhejiang Province, 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)：	浙江省	市(区县)：
Country：	China	Province：	Zhejiang	City：
单位(医院)：	宁波大学附属康宁医院	具体地址：	中国浙江省宁波市镇海区庄市街道庄俞南路1号
Institution hospital：	Affiliated Kangning Hospital of Ningbo University(Ningbo Kangning Hospital)	Address：	No. 1 Zhuangyun South Road, Zhuangshi Street, Zhenhai District, Ningbo City, Zhejiang Province, China

经费或物资来源：

宁波市科学与技术局

Source(s) of funding：

Ningbo Municipal Science and Technology Bureau

研究疾病：

精神疾病

Target disease：

mental illness

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

病例对照研究

Study design：

Case-Control study

研究目的：

1. 主要目的：验证基于 AI 辅助压缩感知（ACS）技术的超快速脑 MRI（三维 T1WI 序列）在不同加速因子（2-10）下的性能，确定能同时满足 109 个脑区分割一致性、148 个脑皮层部位多参数（体积、厚度、面积、曲率等）测量准确性及病灶检测临床需求的最佳加速因子，实现扫描时间大幅缩短（目标缩短至 1 分 30 秒），为 ACS 技术在精神疾病脑结构分析中的临床应用提供科学、标准化的加速因子选择依据。 2. 次要目的：（1）探究脑皮层测量中曲率一致性波动较大的核心原因，明确误差来源（如软件差异、扫描重复性、设备一致性等），为算法优化和测量标准化提供支撑；（2）建立 “影像质量 - 诊断效能 - 多中心一致性 - 长期稳定性” 四维度验证体系，评估 ACS 技术在多中心、不同设备条件下的普适性和可重复性；（3）形成 “扫描 - 分析 - 诊断” 标准化流程（SOP）及《ACS 脑结构扫描操作规范》，为临床推广应用提供实操指导；（4）开发个性化扫描方案推荐系统，实现基于患者特征（年龄、BMI、病症类型等）的扫描参数动态匹配；（5）验证 ACS 技术对精神疾病（抑郁症、精神分裂症等）早期诊断和疗效评估的临床价值，同时为国产 MRI 设备性能优化提供数据支持；（6）通过多软件（uAI Discover-Brain、FreeSurfer、DPABI 等）交叉验证，推动脑结构分析算法的标准化发展。

Objectives of Study：

1. Primary Objective: To validate the performance of ultra-fast brain MRI (3D T1-weighted imaging sequences) utilising AI-assisted compressed sensing (ACS) technology across varying acceleration factors (2–10). This aims to determine the optimal acceleration factor that simultaneously meets clinical requirements for consistent segmentation across 109 brain regions, accurate multi-parameter measurements (volume, thickness, area, curvature, etc.) across 148 cortical locations, and lesion detection. This approach achieves a substantial reduction in scan time (target reduction to 1 minute 30 seconds), thereby providing a scientific, standardised basis for selecting acceleration factors for the clinical application of ACS technology in structural analysis of psychiatric disorders. 2. Secondary Objectives: (1) Investigate core causes of significant curvature consistency fluctuations in cortical measurements, identifying sources of error (e.g., software variations, scan repeatability, device consistency) to support algorithm optimisation and measurement standardisation; (2) Establish a four-dimensional validation framework encompassing "image quality – diagnostic efficacy – multi-centre consistency – long-term stability" to assess the universality and reproducibility of ACS technology across multiple centres and diverse equipment configurations; (3) Develop standardised operating procedures (SOPs) for the "scanning – analysis – diagnosis" workflow alongside the ACS Brain Structural Scanning Operational Specifications, providing practical guidance for clinical implementation; (4) Develop a personalised scan protocol recommendation system enabling dynamic parameter matching based on patient characteristics (age, BMI, disease type, etc.); (5) Validate the clinical value of ACS technology for early diagnosis and treatment efficacy assessment of psychiatric disorders (e.g., depression, schizophrenia), while providing data support for optimising domestic MRI equipment performance; (6) Advance standardisation of brain structural analysis algorithms through cross-validation across multiple software platforms (uAI Discover-Brain, FreeSurfer, DPABI, etc.).

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Population types: Comprising healthy volunteers and individuals with psychiatric disorders (depression, schizophrenia), where patients must have received a clinically confirmed diagnosis (meeting relevant diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) or the International Classification of Diseases (ICD-11));
2.  Age range: 25–45 years;
3. Gender Ratio: Approximately 1:1 male-to-female ratio to balance potential gender effects on brain structural measurements;
4. Examination Suitability: No contraindications for MRI scanning (e.g., no metallic implants, no claustrophobia, no severe hepatic or renal impairment affecting examination safety);
5. Compliance requirements: Ability to complete 10 scanning protocols (standard + 9 ACS acceleration factor scans) and subsequent assessments; good communication skills enabling comprehension and signing of informed consent;
6. Image quality baseline: Expected ability to maintain head stability during scanning with minimal motion artefacts, ensuring images are suitable for subsequent analysis.
Rationality and Feasibility of Criteria: Inclusion criteria focus on the study's core objective (validating ACS technology's performance in analysing brain structures in psychiatric disorders), encompassing both healthy individuals and patients with target conditions to establish brain structure comparisons between normal and pathological states; Age and gender stratification aligns with clinical population distribution characteristics, mitigating baseline bias; MRI contraindications and compliance requirements ensure scanning safety and data validity. Recruitment sources are clearly defined (patients attending Ningbo University Affiliated Kangning Hospital and collaborating institutions, alongside publicly recruited volunteers), providing ample recruitment potential and strong feasibility.

排除标准：

1）器质性脑部疾病：患有脑梗死、脑出血、脑炎、脑肿瘤、脑囊肿、先天性脑畸形等影响脑结构的器质性疾病，此类疾病会干扰精神疾病相关脑结构差异的分析；（2）脑白质病变程度：Fazekas 分级＞2 级，严重脑白质病变可能掩盖皮层参数测量信号，导致测量误差增大；（3）图像质量干扰：既往 MRI 检查存在明显运动伪影或图像质量不合格史，或预计无法配合保持头部稳定，可能导致扫描图像无法满足脑区分割及皮层测量需求；（4）其他干扰因素：存在酒精依赖、药物滥用史（近 6 个月内），或正在使用可能影响脑结构的药物（如长期大剂量激素等），可能干扰研究指标的客观性；（5）特殊人群：孕妇、哺乳期女性，以及存在认知功能严重障碍、无法完成检查配合的人群，避免检查风险及数据可靠性不足。标准合理性与可行性：排除标准针对性排除了可能混淆研究核心指标（脑区分割一致性、皮层参数测量准确性）的干扰因素，确保研究对象的同质性，避免因合并其他脑部疾病、严重病变或干扰因素导致结果偏倚；各项排除标准均有明确的临床诊断或检查依据（如 Fazekas 分级可通过既往影像资料判定），操作简便，可行性高。

Exclusion criteria：

1. Organic brain disorders: Conditions affecting brain structure such as cerebral infarction, cerebral haemorrhage, encephalitis, brain tumours, brain cysts, and congenital brain malformations. Such disorders may interfere with analyses of brain structural differences associated with psychiatric conditions; 2. Extent of white matter lesions: Fazekas grade >2. Severe white matter lesions may obscure cortical parameter measurement signals, increasing measurement error; 3. Image quality interference: History of significant motion artefacts or substandard image quality in previous MRI examinations, or anticipated inability to maintain head stability, may render scan images unsuitable for brain region segmentation and cortical measurement requirements; 4. Other confounding factors: History of alcohol dependence or substance abuse (within the past 6 months), or current use of medications potentially affecting brain structure (e.g., long-term high-dose corticosteroids), may compromise the objectivity of study metrics; 5. Special populations: Pregnant women, lactating females, and individuals with severe cognitive impairment unable to complete examination cooperation, to avoid examination risks and insufficient data reliability. Rationality and Feasibility of Criteria: The exclusion criteria specifically eliminate confounding factors that could compromise core study indicators (consistency of brain region segmentation, accuracy of cortical parameter measurement), ensuring homogeneity among subjects and preventing result bias from comorbid brain disorders, severe pathologies, or interference factors; Each exclusion criterion is supported by clear clinical diagnostic or examination evidence (e.g., Fazekas grading can be determined via historical imaging records), ensuring straightforward implementation and high feasibility.

研究实施时间：

Study execute time：

从 From 2026-05-01 00:00:00至 To 2027-07-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-05-01 00:00:00 至 To 2027-03-08 00:00:00

干预措施：

Interventions：

组别：	疾病组	样本量：	450
Group：	Disease group	Sample size：	450
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	健康对照组	样本量：	50
Group：	Healthy control group	Sample size：	50
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	浙江	市(区县)：	宁波
Country：	China	Province：	Zhejiang	City：	Ningbo
单位(医院)：	宁波大学附属康宁医院	单位级别：	三甲
Institution hospital：	Affiliated Kangning Hospital of Ningbo University	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	浙江	市(区县)：	宁波
Country：	China	Province：	Zhejiang	City：	Ningbo
单位(医院)：	宁波市中西医结合医院	单位级别：	三级
Institution hospital：	Ningbo Hospital of Integrated Traditional Chinese and Western Medicine	Level of the institution：	Tertiary

测量指标：

Outcomes：

指标中文名：	脑皮层	指标类型：	主要指标
Outcome：	cerebral cortex	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	脑区分割一致性（ICC 值）	指标类型：	主要指标
Outcome：	Brain region segmentation consistency (ICC value)	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	扫描时间达标率	指标类型：	主要指标
Outcome：	Scan Time Compliance Rate	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	组织：
Sample Name：	None	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	25	岁 years
最大 Max age	45	岁 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）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是Yes
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）：	2028年后公开数据，采用网络平台https://datacite.org
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Public data after 2028 will be made available via the online platform https://datacite.org
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：	本研究数据采集和管理采用“纸质CRF记录+电子EDC系统”相结合的方式，确保数据的真实性、完整性、私密性和可溯源性。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	This study employs a combined approach of paper-based CRF recording and electronic data capture (EDC) systems for data collection and management, ensuring the authenticity, completeness, confidentiality, and traceability of data.
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2026-04-13 14:45:20