UMIN-CTR Clinical Trial

Basic information
Public title	Molecular imaging of DNA synthesis using a new PET tracer: clinical study of diagnosis for cardiac sarcoidosis
Acronym	Clinical study of diagnosis for cardiac sarcoidosis
Scientific Title	Molecular imaging of DNA synthesis using a new PET tracer: clinical study of diagnosis for cardiac sarcoidosis
Scientific Title:Acronym	Clinical study of diagnosis for cardiac sarcoidosis
Region	Japan

Condition
Condition	Cardiac sarcoidosis
Classification by specialty	Medicine in general Cardiology Clinical immunology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the utility of 4DST-PET for diagnosis of cardiac sarcoidosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To explore how 4DST-PET can contribute to diagnosis of cardiac sarcoidosis, compared to FDG-PET.
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	Medicine
Interventions/Control_1	The patients undergo both 4DST- and FDG-PET studies. The findings will be compared reciprocally. In the procedure, clinical findings according to the guideline of management of cardiac sarcoidosis published from the Japanese circulation society is referred.
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) Patient who is suspected cardiac sarcoidosis 2) Age, elder than or equal to 20 years. 3) Completed the written informed consent.
Key exclusion criteria	1) Patient who is in emargency status 2) Patient with severe comorbid disease including liver dysfunction, renal dysfunction or metabolic damage. 3) Patient with severe mental disease. 4) Patient who have possibility of pregnant, during lactation 5) Patient who have history of allergy to thyothyidine and thymidine 6) Those who are determined as not appropriate for the study by the principal investigator.
Target sample size	95

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Ryogo Minamimoto
Organization	National Center for Global Health and Medicine
Division name	Nuclear Medicine
Zip code
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL	03-3202-7181
Email	rminamimoto@hosp.ncgm.go.jp

Public contact
1st name of contact person	1st name Middle name Last name Ryogo Minamimoto
Organization	National Center for Global Health and Medicine
Division name	Nuclear Medicine
Zip code
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL	03-3202-7181
Homepage URL
Email	rminamimoto@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	National Center for Global Health and Medicine
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
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

Other administrative information
Date of disclosure of the study information	2018 Year 02 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	Terminated
Date of protocol fixation	2017 Year 12 Month 20 Day
Date of IRB	2017 Year 12 Month 18 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 12 Month 30 Day
Last modified on	2019 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034988