UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Studies on simultaneous myocardial imaging with 123I and 201Tl dual radionuclides using cardiac focusing collimator
Title of the study (Brief title)	Studies on simultaneous myocardial imaging with 123I and 201Tl dual radionuclides using cardiac focusing collimator
Region	Japan

Condition
Condition	Cardiovascular disease
Classification by specialty	Cardiology Radiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness of a cardiac focusing-collimator (CF)(variable-focus collimator) in simultaneous myocardial imaging with 123I and 201Tl-SPECT .
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We evaluate the usefulness of a cardiac focusing-collimator (CF)(variable-focus collimator) in simultaneous myocardial imaging with 123I and 201Tl-SPECT .
Key secondary outcomes

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	123I-BMIPP SPECT, 201Tl SPECT
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who underwent 201Tl and 123I-BMIPP SPECT.
Key exclusion criteria	none
Target sample size	20

Research contact person
Name of lead principal investigator	Katsuhiko Kato
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Radiological and Medical Laboratory Sciences
Address	1-20, Daikominami 1-chome, Higashi-ku, Nagoya
TEL	052-744-2553
Email	katokt@med.nagoya-u.ac.jp

Public contact
Name of contact person	Katsuhiko Kato
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Radiological and Medical Laboratory Sciences
Address	1-20, Daikominami 1-chome, Higashi-ku, Nagoya
TEL	052-744-2553
Homepage URL
Email	katokt@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 27 Day
Anticipated trial start date	2017 Year 01 Month 27 Day
Last follow-up date
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

Management information
Registered date	2017 Year 01 Month 04 Day
Last modified on	2019 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029308