UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015271 |
|---|---|
| Receipt number | R000017761 |
| Scientific Title | Development of the tumor-specific imaging technique on targeting amino acid transporter |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2016/09/27 12:09:41 |
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Basic information
Public title
Development of the tumor-specific imaging technique on targeting amino acid transporter
Acronym
Development of the novel tumor-specific imaging technique
Scientific Title
Development of the tumor-specific imaging technique on targeting amino acid transporter
Scientific Title:Acronym
Development of the novel tumor-specific imaging technique
Region
| Japan |
Condition
Condition
Healthy subjects, Brain tumor patients
Classification by specialty
| Neurosurgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop the tumor-specific imaging technique on targeting aminiacid transporter
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accumulation level of [18F]AA-7 to brain tumor measured using PET
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
[18F]AA-7
Interventions/Control_2
[18F]AA-7
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with brain tumor in Osaka City University Hospital and healthy subjects, who give informed consent.
Key exclusion criteria
Participants
1) with past or currrent history of serious medical illness and/or brain organic desease
2) with pregnancy women
3) who is contradicated for the use of MRI
4) who are judged as not suitable for participation in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyoshi Watanabe |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Physiology
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka-shi, Osaka 545-8585, Japan
TEL
06-6645-3711
yywata@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Nozaki |
Organization
RIKEN
Division name
Center for Life Science Technologies
Zip code
Address
6-7-3 Minatojima-Minamimachi,Chuo-ku,Kobe Hyogo, 650-0047, JAPAN
TEL
078-304-7124
Homepage URL
satoshi.nozaki@riken.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
大阪市立大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | 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
| 2014 | Year | 09 | Month | 27 | Day |
Last modified on
| 2016 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017761
