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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026565
Receipt No. 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

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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
Email 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
Email kkudo@huhp.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030503

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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