UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Objective olfaction test with olfacto-scintigraphy
Title of the study (Brief title)	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	Hideaki Shiga
Organization	Kanazawa Medical University
Division name	Otorhinolaryngology
Address	1-1 Daigaku, Uchinada-machi, Kahokugun, Ishikawa, JAPAN
TEL	076-218-8147
Email	ent@kanazawa-med.ac.jp

Public contact
Name of contact person	Hideaki Shiga
Organization	Kanazawa Medical University
Division name	Otorhinolaryngology
Address	1-1 Daigaku, Uchinada-machi, Kahokugun, Ishikawa, JAPAN
TEL	076-218-8147
Homepage URL
Email	ent@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 04 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027081