UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007146 |
|---|---|
| Receipt number | R000008405 |
| Scientific Title | The diagnosis of malignacy and treatment protocolin hepatocellular carcinoma ; The establish of method by 18F-fluorodeoxyglucose-positron emission tomography-computed tomography |
| Date of disclosure of the study information | 2012/01/27 |
| Last modified on | 2012/01/26 16:39:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
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
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Assessment
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
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
Research contact person
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
Public contact
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
Sponsor or person
Institute
Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine
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
Address
Tel
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
| 2012 | Year | 01 | 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
| 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
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.
Management information
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
