UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Additional Gadoxetic Acid Enhanced-MRI for Liver Metastases
Title of the study (Brief title)	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	Kuni Ohtomo
Organization	The University of Tokyo Hospital
Division name	Department of Radiology
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	Takeyuki Watadani
Organization	The University of Tokyo Hospital
Division name	Department of Radiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000017480