UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of the hepato-biliary-pancreatic 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	hepatocellular carcinoma,biliary tract cancer,pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To develop the novel imaging technique for hepato-biliary-pancreatic tumor
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intratumoral accumulation and distribution of the PET probe ([18F]AA-7 and [18F]FDG) before and after treatment
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]FDG
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients 1) with hepato-biliary-pancreatic tumor in Osaka City University Hospital, who give informed consent. Diagnostic criteria Hepatocellular carcinoma: imaging (ultrasonography, CT, MRI, angiography), tumor marker (AFP, PIVKA-2), pathological diagnosis Biliary and pancreatic tumor: imaging (ultrasonography, CT, MRI, angiography, ERCP) , tumor marker (CEA, CA19-9, SPAN-1, DUPAN-2), pathological diagnosis 2) who is between 20 and 80 years old (regardless of sex) 3) who give informed consent 4) who can be hospitalized before examination for controlling blood sugar and amino acid levels 5) who can survive more than six months 6) who can reach the ECOG score 0 or 1
Key exclusion criteria	Patients 1) with serious brain and/or kidney disease 2) with a history of chemotherapy 3) with pregnancy women 4) with claustrophobia 5) with grade C of Child-Pugh score (Hepatocellular carcinoma) 6) who are judged as not suitable for participation in this study
Target sample size	60

Research contact person
Name of lead principal investigator	Norifumi Kawada
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Hepatology
Address	1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
TEL	06-6645-3905
Email	kawadanori@med.osaka-cu.ac.jp

Public contact
Name of contact person	Satoshi Nozaki
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Physiology
Address	1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
TEL	06-6645-3711
Homepage URL
Email	satoshi.nozaki@riken.jp

Sponsor
Institute	Osaka City University
Institute
Department

Funding Source
Organization	MEXT
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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付属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 01 Day
Anticipated trial start date	2017 Year 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 01 Day
Last modified on	2018 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028872