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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name