UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of the tumor-specific imaging technique on targeting amino acid transporter
Title of the study (Brief title)	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	Yasuyoshi Watanabe
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Physiology
Address	1-4-3 Asahimachi, Abeno-ku, Osaka-shi, Osaka 545-8585, Japan
TEL	06-6645-3711
Email	yywata@med.osaka-cu.ac.jp

Public contact
Name of contact person	Satoshi Nozaki
Organization	RIKEN
Division name	Center for Life Science Technologies
Address	6-7-3 Minatojima-Minamimachi,Chuo-ku,Kobe Hyogo, 650-0047, JAPAN
TEL	078-304-7124
Homepage URL
Email	satoshi.nozaki@riken.jp

Sponsor
Institute	Osaka City University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017761