UMIN-CTR Clinical Trial

Public title

The diagnosis of malignacy and treatment protocolin hepatocellular carcinoma ; The establish of method by 18F-fluorodeoxyglucose-positron emission tomography-computed tomography

Acronym

The diagnosis of malignacy and treatment protocolin HCC ; The establish of method by 18F-FDG-PET/CT

Scientific Title

The diagnosis of malignacy and treatment protocolin hepatocellular carcinoma ; The establish of method by 18F-fluorodeoxyglucose-positron emission tomography-computed tomography

Scientific Title:Acronym

The diagnosis of malignacy and treatment protocolin HCC ; The establish of method by 18F-FDG-PET/CT

Region

Japan

Condition

hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of study was to investigate the accuracy of diagnosis intrahepatic metastasis and microvascular invasion in HCC by standardized uptake value and to analyze postoperative recurrence rate in patients of HCC after radical operation.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The purpose of study was to measure standardized uptake value in HCC with intrahepatic metastasis and microvascular invasion and to measure the each survival rate after treatment and each event-free survival rate in HCC of high and low standardized uptake value.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients with HCC.
2)Patients whose liver damage score is A or B.
3)Patients who could be examined with FDG-PET/CT.
4)Written agreement of participation for this study could be obtained

Key exclusion criteria

1)Written agreement of participation for this study could not be obtained.
2)Patients who could not be examined with FDG-PET/CT.
3)Patients whose fasting blood glucose is more than 200 mg/dl
4)Patients whose liver damage score is C.
5)Patients whose Indocyanine green retention rate at 15 min (ICGR15) is more than 40%
6)Patients who were estimated that it is inappropriate to participate the study by the responsible physician.

Target sample size

45

Name of lead principal investigator

1st name
Middle name
Last name	Yoichi Hiasa

Organization

Ehime University Graduate School of Medicine

Division name

Department of Gastroenterology and Metabology

Zip code

Address

Shitsukawa, Toon, Ehime 791-0295, Japan

TEL

+81-89-960-5308

Email

Name of contact person

1st name
Middle name
Last name	Hironori Ochi

Organization

Ehime University Graduate School of Medicine

Division name

Department of Gastroenterology and Metabology

Zip code

Address

Shitsukawa, Toon, Ehime 791-0295, Japan

TEL

+81-89-960-5308

Homepage URL

Email

Institute

Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine

Institute

Department

Personal name

Organization

Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

01

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2011

Year

07

Month

01

Day

Date of IRB

Anticipated trial start date

2011

Year

07

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The patients who participate in this study will be received blood biochemical examination and imaging examination, including FDG-PET/CT before therapy.
Compared pathological findings with the results of preoperative examination, we examine which examination is useful for prediction microsatellite lesion. We examine whether pet is useful for predicting the postoperative prognosis.

Registered date

2012

Year

01

Month

26

Day

Last modified on

2012

Year

01

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008405