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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010498
Receipt No. R000012272
Scientific Title Prognostic Value of Dual-time-point 18F-FDG PET in Fibrotic Idiopathic Interstitial Pneumonia
Date of disclosure of the study information 2013/04/15
Last modified on 2015/12/19

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Basic information
Public title Prognostic Value of Dual-time-point 18F-FDG PET in Fibrotic Idiopathic Interstitial Pneumonia
Acronym Prognostic Value of Dual-time-point 18F-FDG PET in Fibrotic Idiopathic Interstitial Pneumonia
Scientific Title Prognostic Value of Dual-time-point 18F-FDG PET in Fibrotic Idiopathic Interstitial Pneumonia
Scientific Title:Acronym Prognostic Value of Dual-time-point 18F-FDG PET in Fibrotic Idiopathic Interstitial Pneumonia
Region
Japan

Condition
Condition Idiopathic interstital pneumonia
Classification by specialty
Pneumology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to clarify whether dual-time-point 18F-FDG PET imaging results are useful to predict long-term survival of IPF and NSIP patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Overall survival after 18F-FDG PET examination
Key secondary outcomes 1-year change of pulmanary function tests and computed tomography findings after 18F-FDG PET examination

Base
Study type

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
Other
Interventions/Control_1 All patients with idiopathic interstitial pneumonia undergo dual-time-point 18F-FDG PET of thorax.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Eligible patients were men and women aged 18 years or older with a proven diagnosis of IPF or idiopathic fibrotic NSIP according to the American Thoracic Society/European Respiratory Society statement, with less than 3 years' duration.
Key exclusion criteria Patients with defined connective tissue disease, left ventricular failure, occupational and/or environmental exposure that resulted in interstitial pneumonia, or history of ingestion of a drug or agent known to cause pulmonary fibrosis were excluded from the study.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihiro Umeda
Organization Faculty of Medical Sciences, University of Fukui
Division name Third Department of Internal Medicine
Zip code
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL 0776-61-3111
Email umeda@u-fukui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihiro Umeda
Organization Faculty of Medical Sciences, University of Fukui
Division name Third Department of Internal Medicine
Zip code
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL 0776-61-3111
Homepage URL
Email umeda@u-fukui.ac.jp

Sponsor
Institute Third Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui
Institute
Department

Funding Source
Organization University of Fukui Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Biomedical Imaging Research Center, Faculty of Medical Sciences, Universtity of Fukui
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 福井大学医学部附属病院(福井県)

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/26359263
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 Completed
Date of protocol fixation
2007 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 10 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
2013 Year 04 Month 15 Day
Last modified on
2015 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012272

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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