UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016485
Receipt number R000019141
Scientific Title Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome
Date of disclosure of the study information 2015/02/09
Last modified on 2018/01/24 09:39:06

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Basic information

Public title

Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome

Acronym

PD-1

Scientific Title

Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome

Scientific Title:Acronym

PD-1

Region

Japan


Condition

Condition

Healthy subjects, Parkinson's disease patients and Parkinson's syndrome patients

Classification by specialty

Neurology Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Basic data acquisition of PET image of 18F- fluoro-dopa and 11C- raclopride in healthy subjects, Parkinson's disease patients and Parkinson's syndrome patients

Basic objectives2

Others

Basic objectives -Others

Data acquisition

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Integrated ratio of striatum and cerebellum cortex or the occipital lobe

Key secondary outcomes

Standard uptake value(SUV) of the striatum


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Medicine Device,equipment

Interventions/Control_1

Intravenous injection of 18F-fluoro-dopa and 11C-raclopride

Interventions/Control_2

PET imaging

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

35 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy
over 35 years old
Subjects who do not have clinically abnormal findings in the head MRI
Subjects who informed consent was obtained
Sbjects who do not have healthy problem to participate in clinical research

Parkinson's disease/Parkinson's syndrome
over 35 years old
Sbjects who has been diagnosed with Parkinson's disease or Parkinson's syndrome clinically
Subjects who have normal finding or do not have organic lesions to doubt Parkinson's syndrome associated with the central nervous system degenerative disease in MRI imaging
Subjects who informed consent was obtained
Sbjects who do not have healthy problem to participate in clinical research

Key exclusion criteria

Subjects who consciousness is not clear
Subjects with cerebrovascular disorder
Subjects with cardiac dysfunction
Subjects with QT prolongation and ventricular arrhythmias on the electrocardiogram
Subjects with liver and kidney failure
Subjects with gastric ulcer and duodenal ulcer
Subjects with diabetes
Subjects with serious lung disease, bronchial asthma and endocrine disease
Subjects with angle-closure glaucoma and chronic open-angle glaucoma
Subjects who are psychiatric symptoms such as suicidal tendencies
Subjects who are taking non-selective monoamine oxidase inhibitors
Subjects who suffer from the symptomatic parkinsonism by clear organic cause
Subjects who have the history of drug allergy
Subjects who it is difficult to skip Parkinson treatment medicine from the day before
Subjects with rhabdomyolysis
Subjects with malignant syndrome
Subjects with pheochromocytoma
Subjects with prolactin-secreting pituitary tumor
Subjects who are dehydration and malnutrition state
Subjects Who exhibit a strong response to drink
Subjects who are drug dependence, alcohol dependence
Subjects who have participated in clinical research within the past 3 months
Subjects who reserchers judged as inappropriate

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Michio Senda

Organization

Institute of Biomedical Research and Innovation

Division name

Division of Molecular Imaging

Zip code


Address

2-2, Minatojima-Minamimachi, Chuo-ku, Kobe

TEL

078-304-5212

Email

senda@fbri.org


Public contact

Name of contact person

1st name
Middle name
Last name Akihito Ohnishi

Organization

Institute of Biomedical Research and Innovation

Division name

Division of Molecular Imaging

Zip code


Address

2-2, Minatojima-Minamimachi, Chuo-ku, Kobe

TEL

078-304-5212

Homepage URL


Email

ohnishi@fbri.org


Sponsor or person

Institute

Institute of Biomedical Research and Innovation

Institute

Department

Personal name



Funding Source

Organization

Foundation of Biomedical Research and Innovation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

先端医療センター(兵庫県)


Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 09 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Published in Ann Nucl Med 2017; 31:163-171,

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 12 Month 04 Day

Date of IRB


Anticipated trial start date

2015 Year 02 Month 25 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 02 Month 09 Day

Last modified on

2018 Year 01 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019141


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name