UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026243 |
|---|---|
| Receipt number | R000030142 |
| Scientific Title | Comparison between two separate injections and single injection for double dose Gadolinium enhanced MRI of metastatic brain tumors. |
| Date of disclosure of the study information | 2017/02/22 |
| Last modified on | 2017/02/21 12:20:17 |
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Basic information
Public title
Comparison between two separate injections and single injection for double dose Gadolinium enhanced MRI of metastatic brain tumors.
Acronym
Two separate injections and single injection for double dose Gadolinium enhanced MRI of metastatic brain tumors.
Scientific Title
Comparison between two separate injections and single injection for double dose Gadolinium enhanced MRI of metastatic brain tumors.
Scientific Title:Acronym
Two separate injections and single injection for double dose Gadolinium enhanced MRI of metastatic brain tumors.
Region
| Japan |
Condition
Condition
metastatic brain tumor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the current study is to evaluate number of injections and image acquisition by comparing a method using two separate injections to a method using a single injection for lesion enhancement, detection and delineation for a double-dose contrast material study for brain metastasis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of visualized lesions
Key secondary outcomes
Visualization of the edge or internal structure of the lesions
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Medicine |
Interventions/Control_1
two separate injections group
Interventions/Control_2
single injection group.
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases in which metastatic brain tumor is suspected
Key exclusion criteria
Cases with serious side effect.
Cases with hypersensitivity with Gadoteridol.
Cases with serious renal dysfunction.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Taoka |
Organization
Nara Medical University Hospital
Division name
Department of Radiology
Zip code
Address
840 Shijo-cho Kashihara, Nara
TEL
0744-22-3051
ttaoka@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki Taoka |
Organization
Nara Medical University Hospital
Division name
Department of Radiology
Zip code
Address
840 Shijo-cho Kashihara, Nara
TEL
0744-22-3051
Homepage URL
ttaoka@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
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 | 02 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/mrms/13/4/13_2013-0068/_article
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/mrms/13/4/13_2013-0068/_article
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
| 2010 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 21 | Day |
Last modified on
| 2017 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030142
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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