UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035026
Receipt number R000039941
Scientific Title Predictive of liver function after Stereotactic body radiotherapy using 99mTc-GSA hepatobiliary schinchigraphy
Date of disclosure of the study information 2018/11/27
Last modified on 2021/10/28 14:13:06

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Basic information

Public title

Predictive of liver function after Stereotactic body radiotherapy using 99mTc-GSA hepatobiliary schinchigraphy

Acronym

Predictive of liver function after SBRT using hepatobiliary schinchigraphy

Scientific Title

Predictive of liver function after Stereotactic body radiotherapy using 99mTc-GSA hepatobiliary schinchigraphy

Scientific Title:Acronym

Predictive of liver function after SBRT using hepatobiliary schinchigraphy

Region

Japan


Condition

Condition

Liver tumor

Classification by specialty

Hepato-biliary-pancreatic medicine Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the liver function by the level of segment using schinchigraphy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate the liver function segmentaly using hepatobiliary schinchigrapy

Key secondary outcomes

To evaluate the correation between schinchigraphy image and indocianin green test.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

To take Hepatobilialy schinchigraphy imagign examination 3 month after radiotherapy

Interventions/Control_2


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

100 years-old >

Gender

Male and Female

Key inclusion criteria

The scores of Child-Pugh classification are 5,6 and 7.
There were no thrapy except SBRT
Estimation of life expancy is more than 3 month

Key exclusion criteria

The score of Child^Pugh classification is 8 or more.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Osamu
Middle name
Last name Tanaka

Organization

Asahi University

Division name

Dept. of Radiation Oncology

Zip code

5008523

Address

3-23 Hashimoto-cho gifu gifu Japan

TEL

81582538001

Email

c.bluered@gmail.com


Public contact

Name of contact person

1st name Osamu
Middle name
Last name Tanaka

Organization

Asahi University

Division name

Dept. of Radiation Oncology

Zip code

5008523

Address

3-23 Hashimoto-cho gifu gifu Japan

TEL

81582538001

Homepage URL


Email

c.bluered@gmail.com


Sponsor or person

Institute

Asahi University

Institute

Department

Personal name



Funding Source

Organization

Asahi University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Asahi University Hospital

Address

3-23 Hashimoto-Cho, Gufy city, Gifu

Tel

0582538001

Email

c.bluered@gmail.com


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

朝日大学


Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 27 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

Open public recruiting

Date of protocol fixation

2018 Year 11 Month 27 Day

Date of IRB

2018 Year 11 Month 07 Day

Anticipated trial start date

2018 Year 11 Month 27 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 11 Month 27 Day

Last modified on

2021 Year 10 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039941


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name