UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004571 |
|---|---|
| Receipt number | R000005457 |
| Scientific Title | Efficacy of gadoxetic acid-enhanced MRI in assessing tumor regression after radiofrequency ablation for hepatocellular carcinoma - comparison with CT |
| Date of disclosure of the study information | 2010/11/20 |
| Last modified on | 2010/11/17 14:13:06 |
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Basic information
Public title
Efficacy of gadoxetic acid-enhanced MRI in assessing tumor regression after radiofrequency ablation for hepatocellular carcinoma - comparison with CT
Acronym
EARTH study
Scientific Title
Efficacy of gadoxetic acid-enhanced MRI in assessing tumor regression after radiofrequency ablation for hepatocellular carcinoma - comparison with CT
Scientific Title:Acronym
EARTH study
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the diagnostic efficacy between MRI with gadolinium-ethoxy-benzyl diethylenetriamine-pentaacetic acid and dynamic CT in evaluating the presence of residual tumor after radiofrequency ablation (RFA) for hepatocellular carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of RFA treatment
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with untreated HCC with a diameter of 30 mm or less.
2. Patients with HCC that is enhanced by contrast media in arterial phase of both dynamic CT and EOB-MRI.
3. Patients satisfying the following criteria within 2 months before RFA
Platelet >= 50000/mm3
Serum bilirubin level =< 3 mg/dL
Prothrombin activity >= 50%
Key exclusion criteria
1. Patients having allergy to Gd.
2. Patients having allergy to iodine.
3. Patients with eGFR less than 30 mL/min/1.73 m2
4. Patients with sever heart or lung diseases
5. Patients with asthma
6. Patients with uncontrolled other malignancies
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatehiro Kagawa |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
Shimokasuya 143, Isehara
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
kagawa@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Tokai University School of Medicine
Department of Gastroenterology
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
| 2010 | Year | 11 | Month | 20 | 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
| 2010 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | 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 enrolled to this study receive dynamic CT and EOB-MRI before and after RFA. Two radiologists evaluate the efficacy of RFA blindly, and the patients are followed-up for further 2 years. The diagnostic accuracy is compared between dynamic CT and EOB-MRI.
Management information
Registered date
| 2010 | Year | 11 | Month | 16 | Day |
Last modified on
| 2010 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005457
