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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015024
Receipt No. R000017480
Scientific Title Additional Gadoxetic Acid Enhanced-MRI for Liver Metastases
Date of disclosure of the study information 2014/09/02
Last modified on 2018/03/06

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Basic information
Public title Additional Gadoxetic Acid Enhanced-MRI for Liver Metastases
Acronym Additional Gadoxetic Acid Enhanced-MRI for Liver Metastases
Scientific Title Additional Gadoxetic Acid Enhanced-MRI for Liver Metastases
Scientific Title:Acronym Additional Gadoxetic Acid Enhanced-MRI for Liver Metastases
Region
Japan

Condition
Condition Metastatic liver cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To reveal clinical utility of Gd-EOB-DTPA enhanced MRI in addition to routine enhanced CT for detecting metastatic hepatic cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of metastatic hepatic cancer with gadoxetic acid-enhanced MRI with negative result by contrast-enhanced MDCT.
Key secondary outcomes Imaging characteristics of metastatic hepatic cancer detected by additional gadoxetic acid-enhanced MR

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. Contrast enhanced CT and gadoxetic acid-enhanced MRI were performed within one month interval.
2. No metastatic hepatic cancer was detected by contrast enhanced CT.
Key exclusion criteria 1. Cases with another malignancy.
2. Contraindication for contrast media, either CT or MRI.
Target sample size 450

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kuni Ohtomo
Organization The University of Tokyo Hospital
Division name Department of Radiology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL 03-5800-8666
Email kotomo-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeyuki Watadani
Organization The University of Tokyo Hospital
Division name Department of Radiology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL 03-5800-8666
Homepage URL
Email watadat-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization Bayer phrama, K.K.
Organization
Division
Category of Funding Organization Profit organization
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
2014 Year 09 Month 02 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 Completed
Date of protocol fixation
2014 Year 05 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 10 Day
Last follow-up date
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 10 Month 31 Day
Date analysis concluded
2017 Year 03 Month 15 Day

Other
Other related information Clinical information
MDCT acquisition parameters
EOB-MRI acquisition parameters
MRI findings of metastatic hepatic carcinomas
Diagnostic proof for metastatic hepatic carcionmas
Findings of re-evaluation of MDCT image


Management information
Registered date
2014 Year 09 Month 02 Day
Last modified on
2018 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017480

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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