UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preliminary study of [11C]methionine PET/CT in the diagnosis of IgG4 related disease
Title of the study (Brief title)	Preliminary study of [11C]methionine PET/CT in the diagnosis of IgG4 related disease
Region	Japan

Condition
Condition	IgG4 related disease
Classification by specialty	Clinical immunology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1) To evaluate the ability of [11C] methionine PET/CT in the diagnosis of IgG4 related disease 2) To evaluate the ability of [11C] methionine PET/CT in the prediction of prognosis and therapeutic effect for IgG4 related disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Validation of [11C] methionine PET/CT images from the viewpoint of nuclear medicine physicians 2) Differences between [11C] methionine and [18F] FDG 3) Differences in the uptake between before and after treatment 4) Relevance to the PET uptake with clinical findings in the cases of treatment failure
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine Device,equipment
Interventions/Control_1	[11C]methionine PET/CT, [18F]FDG PET/CT
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) 20 y/o or older 2) Diagnosed as definite, probable or possible group of IgG4-related group by the Comprehensive Diagnostic Criteria for IgG4-Related disease 3) Before the treatment for IgG4-related disease by the administration of steroid 4) Written informed consent was acquired
Key exclusion criteria	1) Pregnancy or possibility of pregnancy 2) Image acquisition by PET/CT is impossible due to the pain or poor performance status 3) Considered inadequate to attend this study by the researcher
Target sample size	30

Research contact person
Name of lead principal investigator	Tomohiko Yamane
Organization	Saitama Medical University International Medical Center
Division name	Nuclear Medicine
Address	Yamane 1397-1, Hidaka
TEL	042-984-4111
Email	yamane@mail.ne.jp

Public contact
Name of contact person	Tomohiko Yamane
Organization	Saitama Medical University International Medical Center
Division name	Nuclear Medicine
Address	Yamane 1397-1, Hidaka
TEL	042-984-4111
Homepage URL
Email	yamane@mail.ne.jp

Sponsor
Institute	Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Saitama Medical University Hospital
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	2016 Year 01 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 11 Month 04 Day
Anticipated trial start date	2016 Year 01 Month 01 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	2015 Year 11 Month 24 Day
Last modified on	2017 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022993