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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038734
Receipt No. R000044147
Scientific Title Assessment of penetrating arteries in insular cortex glioma using 3 tesla and 7 tesla MRI systems.
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/29

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Basic information
Public title Assessment of penetrating arteries in insular cortex glioma using 3 tesla and 7 tesla MRI systems.
Acronym Assessment of penetrating arteries in insular cortex glioma using 3 tesla and 7 tesla MRI systems.
Scientific Title Assessment of penetrating arteries in insular cortex glioma using 3 tesla and 7 tesla MRI systems.
Scientific Title:Acronym Assessment of penetrating arteries in insular cortex glioma using 3 tesla and 7 tesla MRI systems.
Region
Japan

Condition
Condition Insular cortex glioma
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify the benefits of 7 tesla MRI for imaing of penetrating arteries in insular cortex glioma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Results of imaging for penetrating arteirs using 7 tesla MRI are compared with those provided by observations during tumor removal surgery.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Imaging using 7 tesla MRI as the intervention within 2 weeks before surgery.
Interventions/Control_2 Imaging using 3 tesla MRI as the control within 2 weeks before surgery.
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
74 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients who will undergo surgery for removal of insular cortex glioma.
2) Age between 20 and 74.
3) Patients under well conditions which can tolerate to receive MRI.
4) Written informed consent.
Key exclusion criteria 1) Patients who have internal metal materials and/or claustrophobia.
2) Patients who are not eligible for 7 tesla MRI.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Takaaki
Middle name
Last name Beppu
Organization Iwate Medical University
Division name Neurosurgery
Zip code 028-3695
Address Idaidori 2-1 -1, Yahaba-cho, Siwa, Iwate prefecture, Japan
TEL 019-613-7111
Email tbeppu@iwate-med.ac.jp

Public contact
Name of contact person
1st name Takaaki
Middle name
Last name Beppu
Organization Iwate Medical University
Division name Neurosurgery
Zip code 028-3695
Address Idaidori 2-1 -1, Yahaba-cho, Siwa, Iwate prefecture, Japan
TEL 019-613-7111
Homepage URL
Email tbeppu@iwate-med.ac.jp

Sponsor
Institute Department of Neurosurgery, Iwate Medical University
Institute
Department

Funding Source
Organization Department of Neurosurgery, Iwate Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The ethics committee, Iwate Medical University
Address 1-1-1 Idaidori, Yahaba-cho, Shiwa, Iwate prefecture, Japan
Tel 019-651-5111
Email kenkyu-rinri@j.iwate-med.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 岩手医科大学病院(岩手県)

Other administrative information
Date of disclosure of the study information
2019 Year 12 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
2019 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2025 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
2019 Year 11 Month 29 Day
Last modified on
2019 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044147

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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