UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003143 |
|---|---|
| Receipt number | R000003813 |
| Scientific Title | Study for optimaization of abdominal MRI and evaluation of abdominal functional MRI |
| Date of disclosure of the study information | 2010/03/01 |
| Last modified on | 2012/08/08 14:23:29 |
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Basic information
Public title
Study for optimaization of abdominal MRI and evaluation of abdominal functional MRI
Acronym
Study for optimaization of abdominal MRI and evaluation of abdominal functional MRI
Scientific Title
Study for optimaization of abdominal MRI and evaluation of abdominal functional MRI
Scientific Title:Acronym
Study for optimaization of abdominal MRI and evaluation of abdominal functional MRI
Region
| Japan |
Condition
Condition
adults with abdominal diseases who will undergo or underwent abdominal MRI
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Nephrology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Urology |
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate newly developed MR imaging sequences in comparision with standard ones in the abdominal field, with or without recently-available contrast media for liver MRI.
To evaluate newly developed MR imaging sequences in functional assessment of abdominal organs and lesions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Qualitative and quantitative evaluations will be performed for MR image assessments.
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
| Device,equipment |
Interventions/Control_1
New imaging sequences will be added to routine ones.
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
In the retrospective study, all aptients with adequate MR images and sufficient clinical data will be eligible.
In the prospective study, all aptients do not meet the exclusion criteria will be eligible.
Key exclusion criteria
Patients with contraindications for MR exam.
Patients with contraindications for MR contrast media when using contrast medium.
Patients who refuse to participate in this study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Yoshikawa |
Organization
Kobe University Graduate School of Medicine
Division name
Radiology
Zip code
Address
7-5-2 Kusunokicho, Chuoku, Kobe, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University Graduate School of Medicine
Division name
Radiology
Zip code
Address
TEL
078-382-5111
Homepage URL
Sponsor or person
Institute
Department of Radiology
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
Kobe University Hospital
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | 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
| 2010 | Year | 02 | Month | 07 | Day |
Last modified on
| 2012 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003813
