UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010498
Receipt number 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 22:12:54

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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