UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015827 |
|---|---|
| Receipt number | R000018407 |
| Scientific Title | Assessment of Blood Flow, Vascular Permeability and Oxygen Metabolism in Brain Tumors with Magnetic Resonance Imaging |
| Date of disclosure of the study information | 2014/12/03 |
| Last modified on | 2019/02/13 11:08:34 |
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Basic information
Public title
Assessment of Blood Flow, Vascular Permeability and Oxygen Metabolism in Brain Tumors with Magnetic Resonance Imaging
Acronym
Assessment of Oxygen Metabolism in Brain Tumors with MRI
Scientific Title
Assessment of Blood Flow, Vascular Permeability and Oxygen Metabolism in Brain Tumors with Magnetic Resonance Imaging
Scientific Title:Acronym
Assessment of Oxygen Metabolism in Brain Tumors with MRI
Region
| Japan |
Condition
Condition
Normal subjects and patients with brain tumors
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
(1) Establishment of QSM
(2) Feasibility evaluation of QSM, ASL and DCE in assessment of brain tumors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Step 1-2
Correlation between StO2 values of lower extremity calculated by QSM and percutaneously measured by pulse oxymeter.
Step 2
(1)Correlation between StO2 value calculated by QSM and 18F-FMISO accumulation
(2)Comparison between distributions of hypoxic areas illustrated by QSM and FMISO-PET
Key secondary outcomes
Step 1-2
Correration between StO2 value of lower extremity calculated by QSM and applied pressure
Step 2
(1)Correlations between MRI findings in ASL/DCE and 18F-FMISO accumulation
(2)Relation between results in radiation therapy and MR findings before radiation, change in MR findings between pre and post radiation
(3)Relation between histopathology and MR findings in metastatic brain tumors
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Additional performance of QSM, ASL and DCE to conventional MRI
Interventions/Control_2
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Healthy volunteers
1.Healthy male and female (20 - 60 years old)
2.Informed consent is obtained
(2)Patients with brain tumors
1.Adult
2.Brain tumors with diameter of no less than 1cm shown in enhanced MRI
3.FMISO-PET performed at our institute
4.Preserved major organ functions
5.Metastatic brain tumors histopathologically diagnosed by extracranial lesions
6.Informed consent is obtained
Key exclusion criteria
1.Metallic implant or device not applicable to MRI
2.Unable to be at rest on his/her back or claustrophobia
3.Pregnant
4.Other inadequate cases
5.Allergic to gadlinium agents
6.Renal failure
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohsuke Kudo |
Organization
Hokkaido University Hospital
Division name
Department of Diagnostic and Interventional Radiology
Zip code
Address
north 14, west 5, Kita-ku, Sapporo
TEL
011-706-5977
kkudo@huhp.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukie Shimizu |
Organization
Hokkaido University Hospital
Division name
Department of Diagnostic and Interventional Radiology
Zip code
Address
north 14, west 5, Kita-ku, Sapporo
TEL
011-706-5977
Homepage URL
yshimizu1222@yahoo.co.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hitach, Ltd.
Hitach Medical Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hitach, Ltd.
Hitach Medical Corporation
Name of secondary funder(s)
Bayer Yakuhin, Ltd.
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
| 2014 | Year | 12 | Month | 03 | 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
| 2014 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 08 | 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
| 2014 | Year | 12 | Month | 02 | 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=R000018407
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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