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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009830
Receipt No. 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 2013/01/21

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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
Middle name
Last name Ryosuke Tateishi
Organization The university of Tokyo hospital
Division name Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL 03-3815-5411
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shintaro Mikami
Organization The university of Tokyo hospital
Division name Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655
TEL 03-3815-5411
Homepage URL
Email

Sponsor
Institute Gastroenterology of the university of Tokyo hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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
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 Open public recruiting
Date of protocol fixation
2012 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 02 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

Management information
Registered date
2013 Year 01 Month 21 Day
Last modified on
2013 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011515

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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