UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027327 |
|---|---|
| Receipt number | R000031312 |
| Scientific Title | Evaluation of efficacy of quantitate analysis using paired expiratory and inspiratory CT for diagnosis of cystic lung diseases |
| Date of disclosure of the study information | 2017/05/30 |
| Last modified on | 2019/02/27 11:04:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of efficacy of quantitate analysis using paired expiratory and inspiratory CT for diagnosis of cystic lung diseases
Acronym
quantitative analysis of expiratory and inspiratory CT for cystic lung diseases
Scientific Title
Evaluation of efficacy of quantitate analysis using paired expiratory and inspiratory CT for diagnosis of cystic lung diseases
Scientific Title:Acronym
quantitative analysis of expiratory and inspiratory CT for cystic lung diseases
Region
| Japan |
Condition
Condition
cystic lung disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the usefulness of quantitative analysis using paired inspiratory and expiratory CT for diagnosis of cystic lung diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
final diagnosis (pathological, geneticl or clinical diagnosis)
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
CT examination
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
Patients who were suspected for cystic lung disease by medical imagings.
Key exclusion criteria
1. patients accompanied by pneumothorax
2. patients with noticeable lung features besides cystic changes.
3. cystic lesion to entire lung volume ratio is supposed to be greater than 50%
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Suzuki |
Organization
Juntendo University
Division name
Department of Radiology
Zip code
Address
3-1-3, hongo, bunkyo-ku, Tokyo
TEL
03-3813-31111
ka-suzz@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyamoto / Ishiguro |
Organization
Juntendo University
Division name
Department of Radiology
Zip code
Address
3-1-3, hongo, bunkyo-ku, Tokyo
TEL
03-3813-31111
Homepage URL
kenkyu5858@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 30 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 27 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 27 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 27 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 12 | Day |
Last modified on
| 2019 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031312
