UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023519 |
|---|---|
| Receipt number | R000027081 |
| Scientific Title | Objective olfaction test with olfacto-scintigraphy |
| Date of disclosure of the study information | 2016/08/08 |
| Last modified on | 2017/02/09 09:29:14 |
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Basic information
Public title
Objective olfaction test with olfacto-scintigraphy
Acronym
Objective olfaction test with olfacto-scintigraphy
Scientific Title
Objective olfaction test with olfacto-scintigraphy
Scientific Title:Acronym
Objective olfaction test with olfacto-scintigraphy
Region
| Japan |
Condition
Condition
olfactory dysfunction
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the efficacy and the safety of Olfacto-scintigraphy with nasal administration of thallium-201.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of olfactory nerve with Olfacto-scintigraphy 24 hrs after the nasal administration of thallium-201.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with olfactory dysfunction
2) Patients aged 20 years old or more
3) Gender unquestioned
4) Outpatient
5) Patients who have given voluntary written informed consent.
Key exclusion criteria
1) Patients who have serious visceral disease or have early history of the disease.
2) Patients who are pregnant, suspected to be pregnant or breastfeeding.
3) Patients who have early history of serious side-effects or allergy to thallium-201.
4) Patients who are considered not to be eligible by the investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Shiga |
Organization
Kanazawa Medical University
Division name
Otorhinolaryngology
Zip code
Address
1-1 Daigaku, Uchinada-machi, Kahokugun, Ishikawa, JAPAN
TEL
076-218-8147
ent@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Shiga |
Organization
Kanazawa Medical University
Division name
Otorhinolaryngology
Zip code
Address
1-1 Daigaku, Uchinada-machi, Kahokugun, Ishikawa, JAPAN
TEL
076-218-8147
Homepage URL
ent@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
YES
Study ID_1
1387
Org. issuing International ID_1
Kanazawa University Medical Ethics Review Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 04 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Shiga et al. Assessment of olfactory nerve by SPECT-MRI image with nasal thallium-201 administration in patients with olfactory impairments in comparison to healthy volunteers. PLOS ONE 8:e57671, 2013.
Management information
Registered date
| 2016 | Year | 08 | Month | 06 | Day |
Last modified on
| 2017 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027081
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
