UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009830 |
|---|---|
| Receipt number | R000011515 |
| Scientific Title | Examination of the effectiveness of early diagnosis and treatment performed by magnetic resonance imaging (MRI) of hepatocellular carcinoma with liver specific contrast agent. |
| Date of disclosure of the study information | 2013/01/21 |
| Last modified on | 2023/01/30 20:59:34 |
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Basic information
Public title
Examination of the effectiveness of early diagnosis and treatment performed by magnetic resonance imaging (MRI) of hepatocellular carcinoma with liver specific contrast agent.
Acronym
Examination of the effectiveness of early diagnosis and treatment of HCC by EOB-MRI
Scientific Title
Examination of the effectiveness of early diagnosis and treatment performed by magnetic resonance imaging (MRI) of hepatocellular carcinoma with liver specific contrast agent.
Scientific Title:Acronym
Examination of the effectiveness of early diagnosis and treatment of HCC by EOB-MRI
Region
| Japan |
Condition
Condition
Targeted to chronic liver disease patients undergoing abdominal ultrasonography in regular intervals, diagnosed the early hepatocellular carcinoma or more than 2cm 1.0cm.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examine the effectiveness of early diagnosis by MRI examination using liver specific contrast agent, and treatment for the hepatocellular carcinoma of less than 2cm in diameter.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Entry period is three years, and observation period is five years. Comparison the time to recurrence other than the treatment site, or onset naive HCC from the randomization.
Key secondary outcomes
In case of observation for the nodule according to the pathological diagnosis, compare and investigate the rate of progression to hepatocellular carcinoma and overall survival.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
January 31, 2015 February 1, 2012: Registration Period
, The study period: all and January 31, 2020 February 1, 2012, for a loss of phase hepatocytes EOB-MRI is less than 2cm more than 1cm, biopsy liver tumors percutaneously over who were admitted to the hospital . If malignant, surgical resection or percutaneous radiofrequency ablation of liver cancer according to clinical practice guidelines, ultrasonic inspection every four months, follow-up biopsy results by dynamic CT and MRI have been made. If new hepatocellular carcinoma appeared at that time, and the end point test and recurrent "other sites" it. In addition, the re-treatment of local recurrence, it is not an event unless there is a "relapse in other regions."
If the biopsy results are benign, conducted surveillance by ultrasound every month March continues. Hepatocellular carcinoma have emerged from the place where the nodule ischemic performing MRI and dynamic CT if there is a rise in tumor markers and size-up, had been recognized at the time of trial registration if they become cancerous "onset of the same site," with the exception as "first case of other sites" lever, and the trial end point. For each, treatment and follow-up is carried out in accordance with clinical practice guidelines of liver cancer.
Interventions/Control_2
January 31, 2015 February 1, 2012: Registration Period
, All the study period: January 31, 2020 and February 1, 2012, for a loss of hepatocyte phase EOB-MRI of more than 2cm 1cm, without performing a biopsy, ultrasound every month March surveillance tests are done. Similarly for carcinogenesis in the follow-up, and then the "first case of other sites," the carcinogenesis from where the "first case of the same site," different cancerous nodules ischemic at the time of trial registration, the recurrence of other sites after treatment I also made the diagnosis. The procedure of observation when the order to be carried out in accordance with the algorithm of clinical practice guidelines liver cancer nodules ischemic more than 2cm with no stain in the arterial phase in observation of group B appeared group and A is a tumor biopsy subject and treatment, observation is aborted.
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
Patient corresponding to all the following criteria:
Nodules less than 2cm or more 1) 1.0cm
Case of malignant nodules is not clear, in the current clinical practice guidelines liver cancer, 2cm
For those that come to the examination and treatment is recommended.; CT ; MRI abdominal ultrasonography
But easy to recognize in any modality, for nodules less than 2cm, scrutiny,
Adaptation to perform treatment Investigation has not been made.
Nodules of low signal in phase contrast hepatocytes 2) EOB-MRI
Do not allow the hypervascular nodule in the arterial phase MRI or 3) CT
When showed high signal / hypervascular in the arterial phase of dynamic CT / MRI, the Scripture together with 2) above
To be treated for the diagnosis of hepatocellular carcinoma a type not subject of this study.
Key exclusion criteria
Cases correspond to the following exclusion criteria at the time of registration are excluded from the scope.
Cases of liver dysfunction or more points 9 Child-Pugh score
Failure in patients with severe hepatic, there are reports that the rate of excretion into feces after administration of gadolinium has dropped to 6%.
Patients with renal impairment than eGFR 30mL/min
In patients with severe renal impairment, in patients who spoke a foreign nephrogenic systemic fibrosis after gadolinium-based contrast agent other use has been reported
Patients with severe heart disease
Patients with severe respiratory disease
If the physician has deemed inappropriate sharing research or study investigator.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | TATEISHI |
Organization
The university of Tokyo hospital
Division name
Gastroenterology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL
03-3815-5411
tateishi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | TATEISHI |
Organization
The university of Tokyo hospital
Division name
Gastroenterology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL
03-3815-5411
Homepage URL
tateishi-tky@umin.ac.jp
Sponsor or person
Institute
Gastroenterology of the university of Tokyo hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The university of Tokyo hospital
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
Tel
03-3815-5411
crctky-office@umin.ac.jp
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
| 2013 | Year | 01 | Month | 21 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 21 | Day |
Last modified on
| 2023 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011515
