UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010313 |
|---|---|
| Receipt number | 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 11:21:39 |
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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
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
Sponsor or person
Institute
Yokohama City University graduate school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012071
