UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009795 |
|---|---|
| Receipt number | 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 | 2022/08/05 11:30:50 |
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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
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
kshimoji@juntendo.ac.jp
Sponsor or person
Institute
Juntendo Univ.
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2012 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 31 | Day |
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
| 2022 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011475
