UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030049
Receipt number R000034314
Scientific Title PET Imaging-Based Evaluaion of Hepaobiliary transport in Humans with [18F]PTV
Date of disclosure of the study information 2017/11/20
Last modified on 2022/05/25 14:00:21

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Basic information

Public title

PET Imaging-Based Evaluaion of Hepaobiliary transport in Humans with [18F]PTV

Acronym

PET study in Humans with [18F]PTV

Scientific Title

PET Imaging-Based Evaluaion of Hepaobiliary transport in Humans with [18F]PTV

Scientific Title:Acronym

PET study in Humans with [18F]PTV

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate hepatic uptake and subsequent canalicular efflux of [18F]PTV in healthy subjects.

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Disribution of Radioacivity in human dbdominal region and blood after adminisration of [18F]PTV

Key secondary outcomes

metabolite analysis of human blood by TLC


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

This study includes PET scan for 2 times.
For the first visit, the participants take only water.

Interventions/Control_2

For the second visit, they take livalo with water.

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

64 years-old >=

Gender

Male

Key inclusion criteria

healhy male who can have PET scan for about 90 min and temporal blood sampling for about 15 points.

Key exclusion criteria

1.those who have compligating disordes of
severe cenral nervous system, liver, and kidney damage.
2.those who take hyperlipidemia treatment, tuberculosis drug and other treatments for target regions.
3.those who are claustrophobia.
4.those who are not suiable for this study assessed by medical docors judge

Target sample size

8


Research contact person

Name of lead principal investigator

1st name Yasuyoshi
Middle name
Last name Watanabe

Organization

Osaka City Universiy / RIKEN Center for Biosystems Dynamics Research

Division name

Graduate School of Medicine

Zip code

545-8585 / 650-0047

Address

1-4-3, Asahi-machi, Abeno-ku, Osaka / 6-7-3, Minatojima-minamimachi, Chuo-ku, Kobe

TEL

078-304-7101

Email

yywata@riken.jp


Public contact

Name of contact person

1st name Emi
Middle name
Last name Yamano

Organization

RIKEN Center for Biosystems Dynamics Research

Division name

Pathophysiological and Health Science Team

Zip code

650-0047

Address

6-7-3, Minatojima-minamimachi, Chuo-ku, Kobe

TEL

078-304-7124

Homepage URL


Email

emi.yamano@riken.jp


Sponsor or person

Institute

RIKEN Center for Biosystems Dynamics Research

Institute

Department

Personal name



Funding Source

Organization

TAKEDA science foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor

Osaka City University Department of Nuclear Medicine, Osaka City University Department of Physiology, RIKEN

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Safety Center, RIKEN, Kobe

Address

2-2-3,minatojimaminamimachi chuo-ku kobe-city

Tel

078-306-0111

Email

siyaku@ml.riken.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

3849

Org. issuing International ID_1

The Ethics Committee of Osaka City University

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 核医学科、大阪市立大学大学院医学研究科生理学第一


Other administrative information

Date of disclosure of the study information

2017 Year 11 Month 20 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 08 Month 31 Day

Date of IRB

2017 Year 10 Month 04 Day

Anticipated trial start date

2017 Year 11 Month 08 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 03 Month 31 Day

Date trial data considered complete

2021 Year 03 Month 31 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 11 Month 20 Day

Last modified on

2022 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034314


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name