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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005323
Receipt No. R000006327
Scientific Title Diagnosis of Early LIver CAncer Through EOB-MRI Study
Date of disclosure of the study information 2011/03/28
Last modified on 2011/03/27

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Basic information
Public title Diagnosis of Early LIver CAncer
Through EOB-MRI Study
Acronym DELICATE Study
Scientific Title Diagnosis of Early LIver CAncer
Through EOB-MRI Study
Scientific Title:Acronym DELICATE Study
Region
Japan

Condition
Condition HCC borderline lesion
Classification by specialty
Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of our study is to evaluate
a natural course of non-hypervascular HCCs and borderline leions by using EOB-MRI and other imaging modalities.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Evaluate a dediferential rate of non-hypervascular tumors in natural course
Key secondary outcomes 1.Evaluate a dedifential rate of each nodule wheter the result of the image of post-vascular phase of the tumor affect the dedifential rate.
2.Compare the hepatobiliary phase images of EOB-MRI with histological results of tumors.
3.Compare the hepatobiliary phase images of EOB-MRI with expression of transporters of tumors.
4.Compare the dediferention rate of tumors between HBV and HCV patients.
5.Histological evaluation of tumors that
can detect on ultrasonography with magnetic navigation system while EOB-MRI failed to detect.
6.Histological evaluation of tumors that
can detect on EOB-MRI while fundamental B-mode ultrasonography failed to detect.
We use ultrasonography with magnetic navigation system to acquire specimens.

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.20 Years and older.
2.Patient who have HCV, HBV and non-virus related chronic liver disease
without alcohol related choronic liver disease.
3.Nodules that diagnosed non-hyper vascular at least 2 imaging modalities.
4. Patiens who have non-hyper tumors and classical HCCs, but classical HCCs can be treated curatively.
5.Patient who have a treatment career of HCC once in the past, but received a curative treatment.
6.Patients who can receve a regular imaging examinations.
7.Written Informed Consent must be obtained.
8.ECOG Performance status of 0 or 1.
Key exclusion criteria 1.Known allergy to the investigational agent or any agent given in association with this trial.
2.Patiens who have severe liver damage.
3.Asthma patients
4.Patient who has metal in the body
5.patient having the active digestive organs bleeding.It is a case with the hospitalization career within the past one month.
6.A patient of the minority.
7.Pregnant or breast-feeding patients.
8.ECOG Performance status of more than 2.
9. Any condition that could jeopardize the safety of the patient or their compliance in the study
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Kudo
Organization Kinki University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 377-2, Oono-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuo Inoue
Organization Kinki University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 377-2, Oono-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan
TEL
Homepage URL
Email t-inoue@med.kindai.ac.jp

Sponsor
Institute Japan Liver Oncology Group
Institute
Department

Funding Source
Organization Japan Liver Oncology Group
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2011 Year 03 Month 28 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 03 Month 02 Day
Date of IRB
Anticipated trial start date
2011 Year 04 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 purpose of this study is to evaluate
a dediferential rate of non-hypervascular
tumors prospectively by using imaging modalities.

Management information
Registered date
2011 Year 03 Month 27 Day
Last modified on
2011 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006327

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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