UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025110
Receipt number 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 11:37:14

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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 or person

Institute

Osaka City University

Institute

Department

Personal name



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

Value
https://center6.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