臨床研究等提出・公開システム

Date of registration	Dec. 20, 2018
Last modified on	May. 26, 2026
Trial ID	jRCTs041180021

Scientific Title	Objective olfaction test with olfacto-scintigraphy (Objective olfaction test with olfacto-scintigraphy)
Public Title	Objective olfaction test with olfacto-scintigraphy (Objective olfaction test with olfacto-scintigraphy)

Contact for Scientific Queries	Name	Shiga Hideaki
	Affiliation	Kanazawa Medical University Hospital
	Address	1-1,Daigaku,Uchinada,Kahoku,Ishikawa
	Telephone	+81-76-218-8147
	E-mail	shigah@kanazawa-med.ac.jp
Contact for Public Queries	Name	Shiga Hideaki
	Affiliation	Kanazawa Medical University
	Address	1-1,Daigaku,Uchinada,Kahoku,Ishikawa
	Telephone	+81-76-218-8147
	E-mail	shigah@kanazawa-med.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 01, 2010
Actual date of first enrollment		Mar. 29, 2010
Target sample size		150
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	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.
	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.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Olfactory dysfunction
Intervention(s)		The nasal administration of thallium-201.
Primary Outcome(s)		Evaluation of olfactory nerve with Olfacto-scintigraphy 24 hrs after the nasal administration of thallium-201.
Secondary Outcome(s)		1) Safety for the nasal administration of thallium-201 in patients with olfactory dysfunction 2) Association between patient characteristics (including prior treatment) and image analysis findings of olfacto-scintigraphy with nasal administration of thallium-201

Source of Monetary Support	Kanazawa Medical University Otorhinolaryngology

Source of Monetary Support	Grants-in-Aid for Scientific Research (KAKENHI)

Name of Certified Review Board	Kanazawa Medical University Clinical Reseach Review Board
Address	1-1,Daigaku,Uchinada,Kahoku,Ishikawa, Ishikawa
Telephone	+81-76-218-8346
E-Mail	tiken@kanazawa-med.ac.jp
Approval Status	Approval
Date of approval	Dec. 06, 2018

Plan to share IPD	No

Secondary ID(s)	UMIN000023519
Issuing Authority	University hospital Medical Information Network Center

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
8	May. 26, 2026	(this page)	Changes
7	April. 08, 2026	Detail	Changes
6	Mar. 23, 2026	Detail	Changes
5	Feb. 26, 2025	Detail	Changes
4	April. 13, 2023	Detail	Changes
3	Feb. 02, 2022	Detail	Changes
2	May. 13, 2020	Detail	Changes
1	Dec. 20, 2018	Detail

List of change history