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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026243
Receipt No. 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

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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
Email 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
Email ttaoka@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030142

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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