UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A comparative study of chest MRI in respiratory diseases
Title of the study (Brief title)	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	Hiroshi Honda
Organization	Kyushu University, Graduate School of Medical Sciences
Division name	Clinical Radiology
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	Satoshi Kawanami
Organization	Kyushu University, Graduate School of Medical Sciences
Division name	Molecular Imaging & Diagnosis
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 09 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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