UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025253
Receipt number 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 16:59:19

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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 or person

Institute

Kyushu University, Graduate School of Medical Sciences

Institute

Department

Personal name



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

Value
https://center6.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