UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023993
Receipt number R000027618
Scientific Title Tumor identification using fluorescence imaging: comparison of two imaging systems
Date of disclosure of the study information 2016/09/18
Last modified on 2021/03/14 21:30:17

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Basic information

Public title

Tumor identification using fluorescence imaging: comparison of two imaging systems

Acronym

Tumor identification using fluorescence imaging: comparison of two imaging systems

Scientific Title

Tumor identification using fluorescence imaging: comparison of two imaging systems

Scientific Title:Acronym

Tumor identification using fluorescence imaging: comparison of two imaging systems

Region

Japan


Condition

Condition

liver cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

It has been frequently reported the effectiveness of ICG fluorescence imaging in liver cancer, including Hepatocellular carcinoma. However there is still no consciousness in recognition rate by ICG dose and each systems. The difference of tumor recognition rate between two different systems and ICG dosages were investigated.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Tumor recognition rate between two imaging systems

Key secondary outcomes

Tumor recognition rate in the ICG dosages
Tumor recognition rate of each tumors
Tumor recognition rate in the tumor diameter and location of tumors


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Medicine Device,equipment

Interventions/Control_1

Indocyanine Green

Interventions/Control_2

ICG fluorescence imaging systems

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Diseases require liver resection

Key exclusion criteria

History of the hypersensitivity to ICG
Iodine allergy

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Norihiro
Middle name
Last name Kokudo

Organization

Graduate school of medicine, University of Tokyo

Division name

Hepato-Biliary-Pancreas Surgery Division, Department of

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-5411

Email

KOKUDO-2SU@h.u-tokyo.ac.jp


Public contact

Name of contact person

1st name Kosuke
Middle name
Last name Kobayashi

Organization

Graduate school of medicine, University of Tokyo

Division name

Hepato-Biliary-Pancreas Surgery Division, Department of

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-5411

Homepage URL


Email

kobayashik-sur@h.u-tokyo.ac.jp


Sponsor or person

Institute

Graduate school of medicine, University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Graduate school of medicine, University of Tokyo

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB, Graduate school of medicine, University of Tokyo

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

Tel

03-5800-8743

Email

crescent-office@umin.net


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



Other administrative information

Date of disclosure of the study information

2016 Year 09 Month 18 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

2016 Year 03 Month 01 Day

Date of IRB

2016 Year 02 Month 01 Day

Anticipated trial start date

2016 Year 10 Month 31 Day

Last follow-up date

2020 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

2016 Year 09 Month 09 Day

Last modified on

2021 Year 03 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027618


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name