UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005401 |
|---|---|
| Receipt number | R000006181 |
| Scientific Title | Evaluation of effect of chemotherapy for depiction of metastatic liver tumor on gadoxetate disodium enhanced MRI |
| Date of disclosure of the study information | 2011/04/11 |
| Last modified on | 2013/05/07 09:26:22 |
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Basic information
Public title
Evaluation of effect of chemotherapy for depiction of metastatic liver tumor on gadoxetate disodium enhanced MRI
Acronym
Evaluation of effect of chemotherapy on gadoxetate disodium enhanced MRI
Scientific Title
Evaluation of effect of chemotherapy for depiction of metastatic liver tumor on gadoxetate disodium enhanced MRI
Scientific Title:Acronym
Evaluation of effect of chemotherapy on gadoxetate disodium enhanced MRI
Region
| Japan |
Condition
Condition
metastatic liver tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Breast surgery |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of chamotherapy (espesially Lapatinib) on gadoxetate disodium-enhanced MRI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To verify the change on enhancement pattern of liver and vessels, and also the change of capability of detection of tumor with gadoxetate disodium-enhanced MRI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Patients with Lapatinib therapy or patients who are scheduled for Lapatinib therapy
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
(a) Patients older than 20-year-old.
(b) Patients with Lapatinib therapy or patients who are scheduled for Lapatinib therapy.
(c) Patients whose body weight is lower than 100kg.
(d) Patients with informed consent.
Key exclusion criteria
(a) Patients who are contraindicated in MRI examination (for example; patients with pace maker and claustrophobia patients).
(b) Patients with history of severe side effect of gadolinium contrast media and gadoxetate disodium.
(c) Patients with poor performance status.
(d) Patients with bronchial asthma.
(e) Patients with severe liver damage (Serum bilirubin > 2.0mg/dL).
(f) Patients with severe kidney damage (eGFR < 30ml/min/1.73m2).
(g) Gravid or lactating patients and patients who may be pregnant.
(h) Patients whom their doctor decide to be inappropriate for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Awai |
Organization
Hiroshima University
Division name
Department of Diagnostic Radiology
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5257
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Nakamura |
Organization
Hiroshima University
Division name
Department of Diagnostic Radiology
Zip code
Address
TEL
Homepage URL
yukon@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Bayer Schering Pharma
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
広島大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 11 | 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
| 2011 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | 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
| 2011 | Year | 04 | Month | 07 | Day |
Last modified on
| 2013 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006181
