UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026565 |
|---|---|
| Receipt number | R000030503 |
| Scientific Title | Quantitative evaluation of brain perfusion MRI with gadobutrol |
| Date of disclosure of the study information | 2017/03/15 |
| Last modified on | 2019/02/13 11:09:59 |
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Basic information
Public title
Quantitative evaluation of brain perfusion MRI with gadobutrol
Acronym
Quantitative evaluation of brain perfusion MRI with gadobutrol
Scientific Title
Quantitative evaluation of brain perfusion MRI with gadobutrol
Scientific Title:Acronym
Quantitative evaluation of brain perfusion MRI with gadobutrol
Region
| Japan |
Condition
Condition
brain tumor
Classification by specialty
| Radiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the non-inferiority of DSC perfusion MRI with Gadovist 1.0 mol/L at the half injection rate compared with 0.5 mol/L contrast media in calculating CBV(cerebral blood volume),CBF(cerebral blood flow)and generating time intensity curve(TIC)of brain.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
comparison between MCRs (maximum signal change ratio) with gadobutrol and gadoterate meglumine of normal region in both white matter and gray matter
Key secondary outcomes
comparison between MCRs (maximum signal change ratio), CBV (cerebral blood volume), CBF(cerebral blood flow), histogram with gadobutrol and gadoterate meglumine of tumor regions
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
gadobutrol 1.0 M at injection rate of 1.5mL/s
Interventions/Control_2
gadoterate meglumine 0.5 M at injection rate of 3.0 mL/s
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.patient who is performed DSC brain MRI with contrast media
2.adult (20 years old or older) at the time of aquisition of informed consent
3.obtained informed consent
Key exclusion criteria
1.patients with contraindication for MRI
2.patients with contraindication for Gd contrast media
3.patients with CKD(eGFR<30 mL/min/1.73m2)
4.pregnant patient
5.patient who is being treated for asthma
6.any others judged ineligible as a subject by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohsuke Kudo |
Organization
Hokkaido University Hospital
Division name
Department of Diagnositic and Interventional Radiology
Zip code
Address
N14W5, Kita-ku, Sapporo
TEL
011-706-5977
kkudo@huhp.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kohsuke Kudo |
Organization
Hokkaido University Hospital
Division name
Department of Diagnositic and Interventional Radiology
Zip code
Address
N14W5, Kita-ku, Sapporo
TEL
011-706-5977
Homepage URL
kkudo@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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 | 03 | Month | 15 | 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
| 2017 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | 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 | 03 | Month | 15 | Day |
Last modified on
| 2019 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030503
