UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015024 |
|---|---|
| Receipt number | 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 09:03:15 |
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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
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
watadat-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017480
