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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025253
Receipt No. R000028599
Scientific Title A comparative study of chest MRI in respiratory diseases
Date of disclosure of the study information 2017/01/01
Last modified on 2016/12/13

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Basic information
Public title A comparative study of chest MRI in respiratory diseases
Acronym Chest MRI in respiratory diseases
Scientific Title A comparative study of chest MRI in respiratory diseases
Scientific Title:Acronym Chest MRI in respiratory diseases
Region
Japan

Condition
Condition Lung/mediastinal tumors, Interstitial pneumonia, Pulmonary emphysema, COPD, Sarcoidosis, Hypersensitivity pneumonitis, Mycobacteriosis, Fungal diseases
Classification by specialty
Pneumology Chest surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the diagnostic utilities of chest MRI in respiratory diseases
Basic objectives2 Others
Basic objectives -Others To compare the imaging findings of chest MRI and HRCT
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To investigate the diagnostic accuracy for detection and characterization in respiratory diseases by HRCT & MRI (T1WI, T2WI, UTE, DWI, etc), and determine the reproducibility in the subjective parameters (kappa analysis) and objective measurements (T2*value, T2value, ADC etc)
Key secondary outcomes To find the useful MRI findings in clinical settings

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Chest MRI: examination and interpretation
Interventions/Control_2 Chest HRCT: examination and interpretation
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 (1) Patients who undergoes chest CT as a part of clinical examination
(2) Lung/mediastinal tumors, Interstitial pneumonia, Pulmonary emphysema, COPD, Sarcoidosis, Hypersensitivity pneumonitis, Mycobacteriosis, Fungal diseases
(3) Male & Female
(4) Informed consent
(5) Repeated examination
Key exclusion criteria (1) General contraindications for undergoing an MRI as followings
1. Patients who is pregnant
2. Patients with severe claustrophobia
3. Patients who have a heart pacemaker
4. Patients who have an artificial inner ear
5. Patients who have an prosthetic valves
6. Patients is in post-operative status for cerebral aneurysm
7. Patients with dental implants
8. Patients with a tattoo
9. Patients who have the other metallic foreign bodies
10. Patients who is underage (20>)
(2) Patients who cannot keep resting status at the examination
(3) Patients who is under a critical condition
(4) Patients who
(5) Patients without written informed consent
(6) Patients who is regarded as inappropriate by researchers to enroll the study
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Honda
Organization Kyushu University, Graduate School of Medical Sciences
Division name Clinical Radiology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Zip:812-8582
TEL 092-642-5695
Email honda@radiol.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Kawanami
Organization Kyushu University, Graduate School of Medical Sciences
Division name Molecular Imaging & Diagnosis
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Zip:812-8582
TEL 092-642-5695
Homepage URL
Email r-wave@radiol.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University, Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Kyushu University, Graduate School of Medical Sciences
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 01 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 Preinitiation
Date of protocol fixation
2016 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 13 Day
Last modified on
2016 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028599

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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