ChiCTR2400093128 版本V1.0 版本创建时间2024/11/28 17:08:33 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2400093128 

最近更新日期：

Date of Last Refreshed on：

2024-11-28 17:08:11 

注册时间：

Date of Registration：

2024-11-28 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

[18F]- FD4 PET对帕金森综合征患者脑内α-突触核蛋白显像的临床研究

Public title：

Clinical Study of [18F]-FD4 PET Imaging of α-Synuclein in the Brain of Patients with Parkinsonian Disorder

注册题目简写：

English Acronym：

研究课题的正式科学名称：

[18F]- FD4 PET对帕金森综合征患者脑内α-突触核蛋白显像的临床研究

Scientific title：

Clinical Study of [18F]-FD4 PET Imaging of α-Synuclein in the Brain of Patients with Parkinsonian Disorder

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：

葛璟洁 

研究负责人：

管一晖 

Applicant：

Jingjie Ge 

Study leader：

Yihui Guan 

申请注册联系人电话：

Applicant telephone：

+86 139 1774 6638

研究负责人电话：

Study leader's telephone：

+86 21 6428 0718

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：

lovejingjie@126.com

研究负责人电子邮件：

Study leader's E-mail：

guanyihui@hotmail.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：

上海市静安区乌鲁木齐中路12号

研究负责人通讯地址：

上海市静安区乌鲁木齐中路12号

Applicant address：

12 Middle Wulumuqi Road, Shanghai

Study leader's address：

12 Middle Wulumuqi Road, Shanghai

申请注册联系人邮政编码：

Applicant postcode：

200040

研究负责人邮政编码：

Study leader's postcode：

200040

申请人所在单位：

复旦大学附属华山医院

Applicant's institution：

Huashan Hospital, Fudan University, Shanghai, China

研究负责人所在单位：

复旦大学附属华山医院

Affiliation of the Leader：

Huashan Hospital, Fudan University, Shanghai, China

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

(2024)临审第(592)号

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：

复旦大学附属华山医院伦理审查委员会

Name of the ethic committee：

Institutional Review Board of Huashan Hospital (HIRB)

伦理委员会批准日期：

Date of approved by ethic committee：

2024-03-20 00:00:00

伦理委员会联系人：

吴翠云

Contact Name of the ethic committee：

Cuiyun Wu

伦理委员会联系地址：

中国上海市静安区乌鲁木齐中路12号复旦大学附属华山医院门诊10楼科研处

Contact Address of the ethic committee：

Scientific bureau, 10th floor, Outpatient Building, Huashan hospital affiliated to Fudan university, No.12, Middle Wulumuqi Road, Jing'an District, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 5288 8045

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：

复旦大学附属华山医院

Primary sponsor：

Huashan Hospital, Fudan University

研究实施负责（组长）单位地址：

中国上海市静安区乌鲁木齐中路12号复旦大学附属华山医院

Primary sponsor's address：

No.12, Middle Wulumuqi Road, Jing'an District, Shanghai, 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)：

上海

市(区县)：

上海

Country：

China

Province：

Shanghai

City：

Shanghai

单位(医院)：

复旦大学附属华山医院

具体地址：

中国上海市静安区乌鲁木齐中路12号复旦大学附属华山医院

Institution
hospital：

Huashan hospital, Fudan University, Shanghai, China

Address：

No.12, Middle Wulumuqi Road, Jing'an District, Shanghai, China

经费或物资来源：

国家自然科学基金

Source(s) of funding：

National Natural Science Foundation of China

Target disease：

Parkinsonian Disorder

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：

0

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

本研究的目的在于建立[18F]- FD4 PET显像的方法，观察其生理性和病理性分布特征，在此基础上评估上述显像剂在PD、MSA、DLB患者中的诊断效能。  

Objectives of Study：

The purpose of this study is to establish a method for [18F] - FD4 PET imaging in human being and to observe its physiological and pathological distribution characteristics. We also want to evaluate the diagnostic efficacy of the above imaging agents in PD, MSA, and DLB patients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 健康对照者： a.年龄在45~70岁之间；性别不限。 b.经研究者通过认知测试认定认知功能正常。CDR评分为0分。 c.经研究者确认无神经系统疾病、重大慢性疾病、恶性肿瘤或急性传染病等。 d.无与运动障碍、认知障碍有关的神经系统性疾病家族史。 e.在进行任何评估之前，理解并签署书面知情同意书。 f.女性受试者须有医疗记录证明其已通过手术绝育（如子宫切除、双侧卵巢切除或输卵管结扎手术）或绝经一年以上；如仍有受孕能力，须在本研究开始后3个月内采取隔绝避孕措施。 g.男性受试者须在本研究开始后3个月内采取隔绝避孕措施。男性受试者本研究开始后3个月内不得捐献精子。 h.愿意并且有能力配合本研究的所有项目。 2. PD患者： a.年龄在45~70岁之间；性别不限。 b.患者符合PD诊断标准（英国PD协会脑库诊断标准）。确诊患者需要具备下述条件中的3项或3项以上：①单侧起病；②静止性震颤；③疾病逐渐进展；④症状不对称，起病侧受累更重；⑤左旋多巴治疗有明显疗效；⑥左旋多巴导致严重异动症；⑦左旋多巴疗效持续5年或更长时间以上；⑧临床病程10年或更长时间。 c.脑MRI支持PD诊断，并且无其他神经系统疾病证据。 d.须由受试者或其法定监护人、照看者书面签署的知情同意书。 e.如有必要，受试者可由护理人员能够伴随受试者。 f.在进行任何评估之前，受试者或其法定代理人理解并签署书面知情同意书。 g.女性受试者须有医疗记录证明其已通过手术绝育（如子宫切除、双侧卵巢切除或输卵管结扎手术）或绝经一年以上；如仍有受孕能力，须在本研究开始后3个月内采取隔绝避孕措施。 h.男性受试者须在本研究开始后3个月内采取隔绝避孕措施。男性受试者本研究开始后3个月内不得捐献精子。 i.愿意并且有能力配合本研究的所有项目。 3. MSA患者： a.年龄在45~70岁之间；性别不限。 b.患者符合很可能 MSA 的诊断（2008年制定的关于 MSA 诊断的第二次共识）。 c.脑MRI支持MSA诊断，并且无其他神经系统疾病证据。 d.须由受试者或其法定监护人、照看者书面签署的知情同意书。 e.如有必要，受试者可由护理人员能够伴随受试者。 f.在进行任何评估之前，受试者或其法定代理人理解并签署书面知情同意书。 g.女性受试者须有医疗记录证明其已通过手术绝育（如子宫切除、双侧卵巢切除或输卵管结扎手术）或绝经一年以上；如仍有受孕能力，须在本研究开始后3个月内采取隔绝避孕措施。 h.男性受试者须在本研究开始后3个月内采取隔绝避孕措施。男性受试者本研究开始后3个月内不得捐献精子。 i.愿意并且有能力配合本研究的所有项目。 4. DLB患者： a.年龄在45~70岁之间；性别不限。 b.患者符合很可能DLB诊断标准（2005 年第三届DLB 联盟制定的诊断标准）。具体为（1）患者必须存在进行性认知功能减退并达到了影响正常社会和职业功能的程度。明显而持续的记忆减退在早期可不明显，但随着病程进展而逐渐加重；注意力、执行功能和视空间功能损害明显。（2）下列3 项至少具备2 项：1）呈明显波动性的注意力和警醒状态的损害；2）反复发作的形象具体的视幻觉；3）自发性的帕金森症候群。（3）如上述3 项只具备1 项，则下列3 项应至少具备1 项：1）RBD；2）对神经安定剂极度敏感；3）SPECT或PET 显像示基底节DAT 摄取减少。 c.脑MRI支持DLB诊断，并且无其他神经系统疾病证据。 d.须由受试者或其法定监护人、照看者书面签署的知情同意书。 e.如有必要，受试者可由护理人员能够伴随受试者。 f.在进行任何评估之前，受试者或其法定代理人理解并签署书面知情同意书。 g.女性受试者须有医疗记录证明其已通过手术绝育（如子宫切除、双侧卵巢切除或输卵管结扎手术）或绝经一年以上；如仍有受孕能力，须在本研究开始后3个月内采取隔绝避孕措施。 h.男性受试者须在本研究开始后3个月内采取隔绝避孕措施。男性受试者本研究开始后3个月内不得捐献精子。 i.愿意并且有能力配合本研究的所有项目。

Inclusion criteria

1. Healthy Controls: a. Ages between 45 and 70 years; gender is not limited. b. Cognitive function is determined to be normal by the researcher through cognitive testing. CDR score is 0. c. Confirmed by the researcher to have no neurological disease, major chronic disease, malignant tumor, or acute infectious disease, etc. d. No family history of neurological diseases related to movement disorders or cognitive impairment. e. Understand and sign a written informed consent form before any assessment. f. Female subjects must have medical records to prove that they have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy, or tubal ligation) or have been menopausal for more than one year; if they still have the ability to conceive, they must take contraceptive measures to prevent pregnancy within 3 months of the start of the study. g. Male subjects must take contraceptive measures within 3 months of the start of the study. Male subjects are not allowed to donate sperm within 3 months of the start of the study. h. Willing and able to cooperate with all aspects of the study. 2. PD patients: a. Ages between 45 and 70 years; gender is not limited. b. The patients meet the diagnostic criteria for PD (the diagnostic criteria of the UK Parkinson's Disease Association Brain Bank). Confirmed patients need to have at least 3 of the following conditions:① Unilateral onset;② Resting tremor;③ Gradual progression of the disease;④ Symptoms are asymmetrical, with more severe involvement on the affected side;⑤ Levodopa treatment has obvious therapeutic effects;⑥ Levodopa causes severe dyskinesia;⑦ Levodopa has a therapeutic effect that lasts for 5 years or longer;⑧ The clinical course is 10 years or longer. c. Brain MRI supports the diagnosis of PD, and there is no evidence of other neurological diseases. d. A signed informed consent form by the subject or their legal guardian or caregiver. e. If necessary, the subject may be accompanied by a caregiver. f. Before any assessment, the subject or their legal representative understands and signs a written informed consent form. g. Female subjects must have medical records to prove that they have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy, or tubal ligation) or have been menopausal for more than a year; if they still have the ability to conceive, they must take contraceptive measures within 3 months of the start of the study. h. Male subjects must take contraceptive measures within 3 months of the start of the study. Male subjects may not donate sperm within 3 months of the start of the study. i. Willing and able to cooperate with all aspects of the study. 3. MSA patients: a. Between 45 and 70 years old; No gender limitation. b. The patient meets the diagnosis of a probable MSA (the second Consensus on MSA diagnosis developed in 2008). c. Brain MRI supports MSA diagnosis, and there is no evidence of other neurological diseases. d. Informed consent signed in person by the subject or his legal guardian or caregiver. e. Subject may be accompanied by nursing staff if necessary. f. Subject or his legal representative understands and signs a written informed consent prior to any evaluation. g. Female subjects must have medical records showing that they have been surgically sterilized (e.g. hysterectomy, bilateral ovariectomy, or tubal ligation) or have undergone menopause for more than one year; If you are still able to conceive, you should use isolation contraception within 3 months after the start of the study. h. Male subjects were required to take isolation contraception within 3 months after the start of the study. Male subjects are not allowed to donate sperm for 3 months after the start of the study. i. Willing and able to cooperate with all projects of this study. 4. DLB patients: a. Between 45 and 70 years old; No gender limitation. b. The patient meets the probable DLB diagnostic criteria (established by the third DLB Alliance in 2005). Specifically, (1) The patient must have progressive cognitive decline to the extent that it affects normal social and occupational functioning. Significant and persistent memory loss is not evident in the early stages, but gradually worsens as the disease progresses; Attention, executive function and visuospatial function were significantly impaired. (2) At least two of the following three items are present: 1) Impairment of a significantly fluctuating state of attention and alertness; 2)Recurrent image-specific visual hallucinations; 3)Spontaneous Parkinson's syndrome. (3) If only one of the above three items is available, at least one of the following three items shall be available: 1)RBD; 2)Extremely sensitive to neuroleptics; 3)SPECT or PET imaging showed decreased DAT uptake in basal ganglia. c. Brain MRI supported the diagnosis of DLB, and there was no evidence of other neurological diseases. d. Informed consent signed in person by the subject or his legal guardian or caregiver. e. Subject may be accompanied by nursing staff if necessary. f. Subject or his legal representative understands and signs a written informed consent prior to any evaluation. g. Female subjects must have medical records showing that they have been surgically sterilized (e.g. hysterectomy, bilateral ovariectomy, or tubal ligation) or have undergone menopause for more than one year; If you are still able to conceive, you should use isolation contraception within 3 months after the start of the study. h. Male subjects were required to take isolation contraception within 3 months after the start of the study. Male subjects are not allowed to donate sperm for 3 months after the start of the study. i. Willing and able to cooperate with all projects of this study.

排除标准：

1. 健康对照者： a.患有严重的其他神经系统疾病，或胃肠道、心血管、肝脏、肾脏、血液系统、肿瘤、内分泌、呼吸系统、免疫缺陷及其他严重疾病。 b.在过去一年内，因其他临床医疗或科学研究需要，接受过本实验范畴以外的电离辐射，从而使年辐射暴露剂量超过50 mSv。 c.药物滥用或酗酒史。 d.妊娠期或哺乳期妇女。 e.静脉条件差，无法耐受重复静脉穿刺。 f.1个月内接受过（效果或安全性不明确的）试验性药物或器械治疗。 g.静脉条件差，无法耐受重复静脉穿刺。 h.具有任何本研究主持者认为本试验相关任何环节可能造成危害或有潜在危害性的状况。 2. PD、MSA和DLB患者 a.患有严重的其他神经系统疾病，或胃肠道、心血管、肝脏、肾脏、血液系统、肿瘤、内分泌、呼吸系统、免疫缺陷及其他严重疾病。 b.在过去一年内，因其他临床医疗或科学研究需要，接受过本实验范畴以外的电离辐射，从而使年辐射暴露剂量超过50 mSv。 c.药物滥用或酗酒史。 d.妊娠期或哺乳期妇女。 e.静脉条件差，无法耐受重复静脉穿刺。 f.1个月内接受过（效果或安全性不明确的）试验性药物或器械治疗。 g.静脉条件差，无法耐受重复静脉穿刺。 h.具有任何本研究主持者认为本试验相关任何环节可能造成危害或有潜在危害性的状况。

Exclusion criteria：

1. Healthy controls: a. Suffering from other serious neurological disorders, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor, endocrine, respiratory, immune deficiency, and other serious diseases. b. In the past year, for other clinical medical or scientific research purposes, received ionizing radiation outside the scope of this study, resulting in an annual radiation exposure dose of more than 50 mSv. c. History of drug or alcohol abuse. d. Pregnant or lactating women. e. Poor venous condition, unable to tolerate repeated venipuncture. f. Treatment with an experimental drug or device (whose efficacy or safety is unclear) within 1 month. g. Poor venous condition, unable to tolerate repeated venipuncture. h. Have any conditions in which the author of this study considers any aspect of this test to be harmful or potentially harmful. 2. Patients with PD, MSA and DLB a. Suffering from other serious neurological disorders, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor, endocrine, respiratory, immune deficiency, and other serious diseases. b. In the past year, for other clinical medical or scientific research purposes, received ionizing radiation outside the scope of this study, resulting in an annual radiation exposure dose of more than 50 mSv. c. History of drug or alcohol abuse. d. Pregnant or lactating women. e. Poor venous condition, unable to tolerate repeated venipuncture. f. Treatment with an experimental drug or device (whose efficacy or safety is unclear) within 1 month. g. Poor venous condition, unable to tolerate repeated venipuncture. h. Have any conditions in which the author of this study considers any aspect of this test to be harmful or potentially harmful.

研究实施时间：

Study execute time：

从 From 2024-03-20 00:00:00至 To 2025-02-28 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-03-22 00:00:00 至 To 2025-02-28 00:00:00  

诊断试验：

Diagnostic Tests：

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）：

PD:英国PD协会脑库诊断标准 MSA:2008年制定的关于 MSA 诊断的第二次共识 DLB:2005 年第三届DLB 联盟制定的诊断标准

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):

PD: UK PD Association Brain Bank diagnostic criteria MSA: the second Consensus on MSA diagnosis developed in 2008 DLB: established by the third DLB Consortium in 2005

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）：

[18F]-FD4的脑内标准摄取比值

Index test:

Standard uptake value ratio of [18F]-FD4

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）

帕金森综合征（PD，MSA，DLB），正常对照

例数:

Sample size:

12

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):

Parkinsonian Disorder(PD,MSA,DLB), normal control

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）：

非帕金森综合征导致的运动障碍的中老年人

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:

Middle-aged and elderly people with movement disorders not caused by Parkinsonian Disorder

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海市 

市(区县)：

  

Country：

China 

Province：

Shanghai 

City：

 

单位(医院)：

复旦大学附属华山医院 

单位级别：

三甲 

Institution
hospital：

Huashan Hospital, Fudan University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

标准摄取比值

指标类型：

主要指标

Outcome：

Standard uptake value 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：

敏感性

指标类型：

次要指标

Outcome：

sensitivity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

特异性

指标类型：

次要指标

Outcome：

specificity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

准确性

指标类型：

次要指标

Outcome：

accuracy

Type：

Secondary 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：

N/A

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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 45 岁 years
最大 Max age 70 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）：

N/A

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

N/A

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）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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）：

请于2025年3月1日后，发送邮件至guanyihui@hotmail.com或者lovejingjie@126.com提出获得数据申请

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

Please emali to guanyihui@hotmail.com or lovejingjie@126.com for request of raw data after March 1st, 2025

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：

病例记录表

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

Case Record Form, CRF

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：

  2024-11-28 17:08:11