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 |
* 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
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
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
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
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
