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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011013
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Middle name
Last name Kuwabara
Organization Chiba University Graduate School of Medicine
Division name Department of Neurology
Zip code
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
Middle name
Last name Hirano
Organization Chiba University Graduate School of Medicine
Division name Department of Neurology
Zip code
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
Institute Chiba University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012886


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