UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000030826