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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025110
Receipt No. R000028872
Scientific Title Development of the hepato-biliary-pancreatic tumor-specific imaging technique on targeting amino acid transporter
Date of disclosure of the study information 2017/01/01
Last modified on 2018/02/01

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Basic information
Public title Development of the hepato-biliary-pancreatic tumor-specific imaging technique on targeting amino acid transporter
Acronym Development of the novel tumor-specific imaging technique
Scientific Title Development of the hepato-biliary-pancreatic tumor-specific imaging technique on targeting amino acid transporter
Scientific Title:Acronym 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
1st name
Middle name
Last name Norifumi Kawada
Organization Osaka City University Graduate School of Medicine
Division name Department of Hepatology
Zip code
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
1st name
Middle name
Last name Satoshi Nozaki
Organization Osaka City University Graduate School of Medicine
Division name Department of Physiology
Zip code
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)

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 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

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
2017 Year 01 Month 01 Day
Date of IRB
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

Other
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

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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