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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009795
Receipt No. R000011475
Scientific Title Preliminary investigation of contrast media dose for sequential diagnosis of cerebral MR perfusion and 3D-MR DSA at 3T MRI
Date of disclosure of the study information 2013/04/01
Last modified on 2020/01/23

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Basic information
Public title Preliminary investigation of contrast media dose for sequential diagnosis of cerebral MR perfusion and 3D-MR DSA at 3T MRI
Acronym Sequential diagnosis of cerebral MR perfusion and 3D-MR DSA at 3T MRI
Scientific Title Preliminary investigation of contrast media dose for sequential diagnosis of cerebral MR perfusion and 3D-MR DSA at 3T MRI
Scientific Title:Acronym Sequential diagnosis of cerebral MR perfusion and 3D-MR DSA at 3T MRI
Region
Japan

Condition
Condition Brain tumor
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To preliminarily investigate imaging protocol of sequential MRI examination of perfusion MRI and 3D-MR DSA by reducing dose (Magnevist) in each imaging at 3T MRI.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Conduct a qualitative assessment of Perfusion MRI and 3DMR DSA
Key secondary outcomes CNR of gray matter and white matter
SNR of gray matter and white matter
Adverse drug reaction to the contrast agent

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Preliminary investigate possibility of reducing half dose (0.05mmol/kg) in perfusion MRI and 3D-MR DSA, respectively. And comparing single dose(0.1mmol/kg) with half dose. Secondly, investigate dose proportion of sequential MRI.
Interventions/Control_2 Preliminary investigate possibility of reducing half dose (0.05mmol/kg) in perfusion MRI and 3D-MR DSA, respectively. And comparing single dose(0.1mmol/kg) with half dose. Secondly, investigate dose proportion of sequential MRI.
Interventions/Control_3 Preliminary investigate possibility of reducing half dose (0.05mmol/kg) in perfusion MRI and 3D-MR DSA, respectively. And comparing single dose(0.1mmol/kg) with half dose. Secondly, investigate dose proportion of sequential MRI.
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) Suspect brain tumor pts or follow up of brain tumor
2) Over 20 years old
3) Accept regardless of gender
4) Clear consciousness
Key exclusion criteria 1) Contraindication of MRI
2) Allergy to Gd contrast media
3) Asthma
4) Severe renal disease
5) During pregnancy or lactation
6) Investigator make a judgmental decision as unsuitableness
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Keigo
Middle name
Last name Shimoij
Organization Juntendo Univ.
Division name Department of Radiology
Zip code 113-8421
Address Hongo 2-1-1, Bunkyo-ku, Tokyo 111-8421
TEL 03-3813-3111
Email kshimoji@juntendo.ac.jp

Public contact
Name of contact person
1st name Keigo
Middle name
Last name Shimoji
Organization Juntendo Univ.
Division name Department of Radiology
Zip code 113-8421
Address Hongo 2-1-1, Bunkyo-ku, Tokyo 111-8421
TEL 03-3813-3111
Homepage URL
Email kshimoji@juntendo.ac.jp

Sponsor
Institute Juntendo Univ.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo Univ IRB
Address Hongo 2-1-1, Bunkyo-ku, Tokyo 111-8421
Tel 03-5802-1584
Email chiken@juntendo.ac.jp

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
2013 Year 04 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
2012 Year 12 Month 11 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 17 Day
Last modified on
2020 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011475

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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