UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015022 |
|---|---|
| Receipt number | R000017474 |
| Scientific Title | Intravoxel incoherent motion diffusion weighted MRI in the classification of brain tumors |
| Date of disclosure of the study information | 2014/09/02 |
| Last modified on | 2017/09/05 11:01:35 |
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Basic information
Public title
Intravoxel incoherent motion diffusion weighted MRI in the classification of brain tumors
Acronym
IVIM imaging in brain tumors
Scientific Title
Intravoxel incoherent motion diffusion weighted MRI in the classification of brain tumors
Scientific Title:Acronym
IVIM imaging in brain tumors
Region
| Japan |
Condition
Condition
brain tumor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic performance of intravoxel incoherent motion (IVIM) MR imaging in brain tumors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Perfusion fraction (f)
Diffusion coefficient (D)
Key secondary outcomes
WHO grade
MIB-1 index
VEGF
CD31
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Brain tumor is suspected, the patient to undergo MRI as a part of the preoperative examination
Written informed consent is obtained.
Key exclusion criteria
Patients who have a heart pacemaker, cochlear implant, metallic foreign body, metallic devices
Patients with severe claustrophobia
Pregnancy
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Honda |
Organization
Departments of Clinical Radiology,
Graduate School of Medical Sciences, Kyushu University
Division name
Clinical Radiology
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
+81926425695
yamakou@radiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Yamashita |
Organization
Departments of Clinical Radiology, Graduate School of Medical Sciences, Kyushu University
Division name
Clinical Radiology
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
+81926425695
Homepage URL
yamakou@radiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Clinical Radiology,
Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
| 2014 | Year | 09 | Month | 02 | 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
| 2014 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
Prospective
Management information
Registered date
| 2014 | Year | 09 | Month | 02 | Day |
Last modified on
| 2017 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017474
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
