UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011013
Receipt number R000012886
Scientific Title [123I]-IMP SPECT perfusion brain image study in healthy subjects for establishing normal brain database for statistical analysis.
Date of disclosure of the study information 2013/07/01
Last modified on 2019/06/25 21:00:17

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Basic information

Public title

[123I]-IMP SPECT perfusion brain image study in healthy subjects for establishing normal brain database for statistical analysis.

Acronym

Brain perfusion SPECT image normal database

Scientific Title

[123I]-IMP SPECT perfusion brain image study in healthy subjects for establishing normal brain database for statistical analysis.

Scientific Title:Acronym

Brain perfusion SPECT image normal database

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Neurology Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To create a normal database on IMP SPECT image analyzed by spatial statistical methods and create normal database on brain perfusion image.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Improve diagnostic power by perfusion image.

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 Behavior,custom

Interventions/Control_1

Administer [123I]-IMP for diagnostic test.Define normal by phsical exams, neuropsychological tests, blood test (complete blood count, chemistry), brain magnetic resonance imaging.

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

40 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy subjects who are cognitively normal and has no previous illness that influences brain.

Key exclusion criteria

(1)Pregnant or have chance to be pregnant
(2)Cognitively impaired
(3)Severe physical illness
(4)Prior head injury
(5)Diabetes
(6)Those who are contraindicated to perform MRI scans
(7)Occluded large cerebral artery.
(8)Severe ischemic brain change
(9)Lacunar stroke > 3mm
(10)Brain cysts.
(11)Chronic pain
(12)Those who does not qualify by the physician.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Satoshi
Middle name
Last name Kuwabara

Organization

Chiba University Graduate School of Medicine

Division name

Department of Neurology

Zip code

260-8670

Address

1-8-1 Inohana,Chuo-ku, Chiba-shi, Chiba 260-8670, Japan

TEL

043-226-2126

Email

kuwabara-s@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Shigeki
Middle name
Last name Hirano

Organization

Chiba University Graduate School of Medicine

Division name

Department of Neurology

Zip code

260-8670

Address

1-8-1 Inohana,Chuo-ku, Chiba-shi, Chiba 260-8670, Japan

TEL

043-226-2126

Homepage URL


Email

s_hirano@chiba-u.jp


Sponsor or person

Institute

Chiba University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Nihon Medi-Physics, Ltd. Co.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB comittee, Graduate School of Medicine, Chiba University, Japan

Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan

Tel

043-226-2003

Email

igaku-rinri@office.chiba-u.jp


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

千葉大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2013 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

2013 Year 05 Month 31 Day

Date of IRB

2013 Year 05 Month 31 Day

Anticipated trial start date

2013 Year 07 Month 01 Day

Last follow-up date

2015 Year 09 Month 30 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete

2016 Year 03 Month 31 Day

Date analysis concluded

2016 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 06 Month 20 Day

Last modified on

2019 Year 06 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012886


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name