UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026862 |
|---|---|
| Receipt number | 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 15:08:44 |
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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
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
yasuyuki@okayama-u.ac.jp
Sponsor or person
Institute
Okayama university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030826
