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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010313
Receipt No. R000012071
Scientific Title Deep inspiratory breath hold PET/CT is useful for monitoring of activity in rheumatic disease associated lung interstitial pneumonitis.
Date of disclosure of the study information 2013/03/26
Last modified on 2013/03/25

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Basic information
Public title Deep inspiratory breath hold PET/CT is useful for monitoring of activity in rheumatic disease associated lung interstitial pneumonitis.
Acronym Deep inspiratory breath hold PET/CT is useful for monitoring of activity in rheumatic disease associated lung interstitial pneumonitis.
Scientific Title Deep inspiratory breath hold PET/CT is useful for monitoring of activity in rheumatic disease associated lung interstitial pneumonitis.
Scientific Title:Acronym Deep inspiratory breath hold PET/CT is useful for monitoring of activity in rheumatic disease associated lung interstitial pneumonitis.
Region
Japan

Condition
Condition interstitial pneumonitis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study examined contributions of deep inspiratory breath hold (DIBH) -FDG-PET/CT to clinical assessment of ILD in collagen diseases.
Basic objectives2 Others
Basic objectives -Others This study examined contributions of deep inspiratory breath hold (DIBH) -FDG-PET/CT to clinical assessment of ILD in collagen diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes SUVmax was well correlated with serum parameters.
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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 deep inspiratory breath hold -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 We assessed ILD patients with collagen diseases.
Key exclusion criteria Non collagen diseases
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki Ishigatsubo
Organization Yokohama City University graduate school of medicine
Division name Department of Internal Medicine and clinical Immunology
Zip code
Address 3-9,Fukuura,Knazawa-ku,Yokohama,Kanagawa
TEL 045-787-2800
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takeaki Uehara
Organization Yokohama City University graduate school of medicine
Division name Department of Internal Medicine and clinical Immunology
Zip code
Address 3-9,Fukuura,Knazawa-ku,Yokohama,Kanagawa
TEL
Homepage URL
Email

Sponsor
Institute Yokohama City University graduate school of medicine
Institute
Department

Funding Source
Organization Yokohama City University graduate school of medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 横浜市立大学附属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 26 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 Enrolling by invitation
Date of protocol fixation
2012 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 25 Day
Last modified on
2013 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012071

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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