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

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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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name