UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021988 |
|---|---|
| Receipt number | R000025331 |
| Scientific Title | Brain activation by PET in the patients with traumatic olfactory impairment before and after healing |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2016/04/19 20:07:17 |
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Basic information
Public title
Brain activation by PET in the patients with traumatic olfactory impairment before and after healing
Acronym
PET study in the patients with traumatic olfactory impairment
Scientific Title
Brain activation by PET in the patients with traumatic olfactory impairment before and after healing
Scientific Title:Acronym
PET study in the patients with traumatic olfactory impairment
Region
| Japan |
Condition
Condition
traumatic olfactory impairment
Classification by specialty
| Oto-rhino-laryngology | Radiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the brain activities in the patients with olfactory impairment
Basic objectives2
Others
Basic objectives -Others
neuroinflammation in the patients with olfactory impairment
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of brain activities in patients with olfactory impairment before and after healing
Key secondary outcomes
Changes of brain activities in patients with olfactory impairment before and after treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
11C-PK11195 (300MBq) is injected within 30s before the start of the PET/CT scan. The dynamic PET/CT data are collected for 60 mins.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with traumatic olfactory impairment from brain injury
Key exclusion criteria
higher brain dysfunction
benzodiazepine medication
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Murata Yoriko |
Organization
Kochi Medical School, Kochi University
Division name
Radiology
Zip code
Address
Kohasu, Nankoku, Kochi, Japan
TEL
088-880-2367
muratay@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Murata Yoriko |
Organization
Kochi Medical School, Kochi University
Division name
Radilogy
Zip code
Address
Kohasu, Nankoku, Kochi, Japan
TEL
088-880-2367
Homepage URL
murartay@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
高知大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | 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
Date of protocol fixation
| 2016 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 19 | Day |
Last modified on
| 2016 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025331
