UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016491 |
|---|---|
| Receipt number | 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 09:35:20 |
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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
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
ohnishi@fbri.org
Sponsor or person
Institute
Institute of Biomedical Research and Innovation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019151
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
