UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Brain activation by PET in the patients with traumatic olfactory impairment before and after healing
Title of the study (Brief title)	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

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	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

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	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	Murata Yoriko
Organization	Kochi Medical School, Kochi University
Division name	Radiology
Address	Kohasu, Nankoku, Kochi, Japan
TEL	088-880-2367
Email	muratay@kochi-u.ac.jp

Public contact
Name of contact person	Murata Yoriko
Organization	Kochi Medical School, Kochi University
Division name	Radilogy
Address	Kohasu, Nankoku, Kochi, Japan
TEL	088-880-2367
Homepage URL
Email	murartay@kochi-u.ac.jp

Sponsor
Institute	Kochi Medical School, Kochi University
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	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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 02 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025331