UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022949
Receipt number R000025337
Scientific Title Multicenter study of [18F]-THK-5351 PET in tauopathies
Date of disclosure of the study information 2016/07/01
Last modified on 2020/01/30 17:34:59

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Basic information

Public title

Multicenter study of [18F]-THK-5351 PET in tauopathies

Acronym

[18F]-THK-5351 PET in tauopathies

Scientific Title

Multicenter study of [18F]-THK-5351 PET in tauopathies

Scientific Title:Acronym

[18F]-THK-5351 PET in tauopathies

Region

Japan


Condition

Condition

tauopathy

Classification by specialty

Neurology Geriatrics Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate usefulness of Tau PET imaging for diagnosing tauopathies and to differentiate aging and pathological tau accumulation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Distribution pattern of [18F]-THK-5351 in each tauopathy.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

PET examination

Interventions/Control_2


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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Clinical suspicious of tauopathy

Key exclusion criteria

#brain infarction, hydrocephalus, metabolic disorder, tumor, inflammation
#claustrophobia
#cardiac pacemaker insertion, metabolic insertion, tatoo
#attending other study including nuclear medicine examination
#decision made by attending physician
#denying to get the results of examinations

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name HARUMASA TAKANO

Organization

National Center of Neurology and Psychiatry

Division name

Integrative Brain Imaging Center

Zip code


Address

4-1-1, Ogawa-Higashi, Kodaira, Tokyo

TEL

042-341-2711

Email

hrtakano@ncnp.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name HARUMASA TAKANO

Organization

National Center of Neurology and Psychiatry

Division name

Integrative Brain Imaging Center

Zip code


Address

4-1-1, Ogawa-Higashi, Kodaira, Tokyo

TEL

042-341-2711

Homepage URL


Email

hrtakano@ncnp.go.jp


Sponsor or person

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name



Funding Source

Organization

The Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

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



Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

No longer recruiting

Date of protocol fixation

2016 Year 04 Month 07 Day

Date of IRB

2016 Year 04 Month 07 Day

Anticipated trial start date

2016 Year 05 Month 12 Day

Last follow-up date

2019 Year 02 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 06 Month 30 Day

Last modified on

2020 Year 01 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025337


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name