UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008340 |
|---|---|
| Receipt number | R000009613 |
| Scientific Title | pancreatic exocrine function with non-contrast MRI:Visualization by Means of MRCP with Spatially Selective Inversion-Recovery Pulse |
| Date of disclosure of the study information | 2012/07/04 |
| Last modified on | 2015/07/20 20:52:21 |
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Basic information
Public title
pancreatic exocrine function with non-contrast MRI:Visualization by Means of MRCP with Spatially Selective Inversion-Recovery Pulse
Acronym
pancreatic exocrine function using non-contrast MRI
Scientific Title
pancreatic exocrine function with non-contrast MRI:Visualization by Means of MRCP with Spatially Selective Inversion-Recovery Pulse
Scientific Title:Acronym
pancreatic exocrine function using non-contrast MRI
Region
| Japan |
Condition
Condition
Chronic pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
That visualized by imaging MRCP with time-spatial labeling inversion pulse(Cine dynamic MRCP images) the flow of pancreatic juice, to examine the correlation between the test PFD, may be able to establish a method for performance evaluation of the exocrine pancreas simple non-invasive.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluation of the correlation between the flow of pancreatic juice in the pancreatic duct using Cine dynamic MRCP images and PFD test.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
MRCP/PFD test
Interventions/Control_2
MRCP
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1; healthy volunteer
cognitive normal subjects without severe physical complication.
2; Chronic pancreatitis
Patients with chronic pancreatitis have already done the PFD.
Key exclusion criteria
subject with claustrophobia who cannot perform MRI examination.
subject who has metal such as pacemaker in the body, and cannot perform MRI examination.
subjects with tattoo.
exclude the patients who are recognized as inadequate patients by doctors with responsibility in this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Yamamoto |
Organization
Kawasaki Medical School
Division name
the Department of Diagnostic Radiology
Zip code
Address
577 Matushima, Kurashiki, Okayama, Japan
TEL
086-462-1111
akira.yamamoto0420@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Yasokawa |
Organization
Kawasaki Medical School
Division name
the Department of Diagnostic Radiology
Zip code
Address
577 Matushima, Kurashiki, Okayama, Japan
TEL
086-462-1111
Homepage URL
roentgen@med.kawasaki-m.ac.jp
Sponsor or person
Institute
the Department of Diagnostic Radiology Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | 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
| 2012 | Year | 07 | Month | 04 | Day |
Last modified on
| 2015 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009613
