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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016491
Receipt No. R000019151
Scientific Title Pilot study about the imaging method of 18F-FLT in primary brain tumor
Date of disclosure of the study information 2015/02/09
Last modified on 2016/02/09

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Basic information
Public title Pilot study about the imaging method of 18F-FLT in primary brain tumor
Acronym BRAIN-FLT
Scientific Title Pilot study about the imaging method of 18F-FLT in primary brain tumor
Scientific Title:Acronym BRAIN-FLT
Region
Japan

Condition
Condition Primary brain tumor
Classification by specialty
Radiology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Basic data acquisition of PET image of 18F-FLT in primary brain tumor
Basic objectives2 Others
Basic objectives -Others Data acquisition
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Integrated ratio of the lesion and the normal portion
Key secondary outcomes Standard uptake value(SUV) of the striatum

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
Medicine
Interventions/Control_1 Intravenous injection of 18F-FLT
PET imaging
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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects who were clinically diagnosed with primary glioma derived brain parenchyma
Over 30 years old
Subjects who the informed consent was obtained
Subjects Who is a health problem to participate in clinical research
Key exclusion criteria Subjects who consciousness is not clear
Subjects with cerebrovascular disorder
Subjects with cardiac dysfunction
Subjects with high degree of arrhythmia
Subjects with liver and kidney failure
Subjects with serious lung disease, bronchial asthma and endocrine disease
Subjects who can not lay in the supine position during about 30 minutes for the pain
Subjects who is extreme claustrophobia
Pregnants or Subjects who have a possibility of pregnancy


Subjects who have the history of drug allergy
Subjects who are dehydration and malnutrition state
Subjects who are drug dependence, alcohol dependence
Subjects who reserchers judged as inappropriate
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michio Senda
Organization Institute of Biomedical Research and Innovation
Division name Division of Molecular Imaging
Zip code
Address 2-2, Minatojima-Minamimachi, Chuo-ku, Kobe
TEL 078-304-5212
Email senda@fbri.org

Public contact
Name of contact person
1st name
Middle name
Last name Akihito Ohnishi
Organization Institute of Biomedical Research and Innovation
Division name Division of Molecular Imaging
Zip code
Address 2-2, Minatojima-Minamimachi, Chuo-ku, Kobe
TEL 078-304-5212
Homepage URL
Email ohnishi@fbri.org

Sponsor
Institute Institute of Biomedical Research and Innovation
Institute
Department

Funding Source
Organization Foundation of Biomedical Research and Innovation
Organization
Division
Category of Funding Organization Non profit foundation
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 先端医療センター(兵庫県)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 09 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 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 09 Day
Last modified on
2016 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019151

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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