UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019908 |
|---|---|
| Receipt number | R000022993 |
| Scientific Title | Preliminary study of [11C]methionine PET/CT in the diagnosis of IgG4 related disease |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2017/08/08 21:46:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Preliminary study of [11C]methionine PET/CT in the diagnosis of IgG4 related disease
Acronym
Preliminary study of [11C]methionine PET/CT in the diagnosis of IgG4 related disease
Scientific Title
Preliminary study of [11C]methionine PET/CT in the diagnosis of IgG4 related disease
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tomohiko Yamane |
Organization
Saitama Medical University International Medical Center
Division name
Nuclear Medicine
Zip code
Address
Yamane 1397-1, Hidaka
TEL
042-984-4111
yamane@mail.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Yamane |
Organization
Saitama Medical University International Medical Center
Division name
Nuclear Medicine
Zip code
Address
Yamane 1397-1, Hidaka
TEL
042-984-4111
Homepage URL
yamane@mail.ne.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2015 | Year | 11 | Month | 04 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022993
