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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026862
Receipt No. R000030826
Scientific Title Hypoxia imaging in the brain and spinal cord of ALS
Date of disclosure of the study information 2017/04/05
Last modified on 2019/04/06

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Basic information
Public title Hypoxia imaging in the brain and spinal cord of ALS
Acronym Hypoxia imaging in the brain and spinal cord of ALS
Scientific Title Hypoxia imaging in the brain and spinal cord of ALS
Scientific Title:Acronym Hypoxia imaging in the brain and spinal cord of ALS
Region
Japan

Condition
Condition neurological diseases
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the hypoxic stress by FMISO PET in the brain and spinal cord of ALS
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluate the hypoxic stress by FMISO PET in the brain and spinal cord of ALS
Key secondary outcomes Evaluate the relationship between physical function or clinical test results and FMISO PET results

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 Prevention
Type of intervention
Medicine
Interventions/Control_1 18F-fluoromisonidazole; FMISO
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
15 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria ALS patients who are in hospital or hospitalized at Okayama University Hospital and are able to communicate in Japanese
Key exclusion criteria In the case that the Research Director or the Research Assignee certifies that it is not suitable for registration
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Abe
Organization Okayama university, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Neurology
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL 086-235-7365
Email yasuyuki@okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuyuki Ohta
Organization Okayama university hospital
Division name Neurology
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL 086-235-7365
Homepage URL
Email yasuyuki@okayama-u.ac.jp

Sponsor
Institute Okayama university
Institute
Department

Funding Source
Organization Okayama university
Organization
Division
Category of Funding Organization Other
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
2017 Year 04 Month 05 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 Completed
Date of protocol fixation
2017 Year 04 Month 05 Day
Date of IRB
2017 Year 05 Month 01 Day
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 04 Day
Last modified on
2019 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030826

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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