UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022314 |
|---|---|
| Receipt number | R000025676 |
| Scientific Title | The evaluation of the macrophage localization in the abdominal aortic aneurysm by SPIO enhanced MRI |
| Date of disclosure of the study information | 2016/05/15 |
| Last modified on | 2016/11/14 12:53:28 |
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Basic information
Public title
The evaluation of the macrophage localization in the abdominal aortic aneurysm by SPIO enhanced MRI
Acronym
The evaluation of the macrophage localization in the abdominal aortic aneurysm by SPIO enhanced MRI
Scientific Title
The evaluation of the macrophage localization in the abdominal aortic aneurysm by SPIO enhanced MRI
Scientific Title:Acronym
The evaluation of the macrophage localization in the abdominal aortic aneurysm by SPIO enhanced MRI
Region
| Japan |
Condition
Condition
Abdominal aortic aneurysm
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate if SPIO enhanced MRI can detect the macrophage localization in the abdominal aortic aneurysm.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To obtain the images of SPIO enhanced MRI and the histological findings of the resected specimen.
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
Plain and SPIO enhanced MRI
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
Patients of the abdominal aortic aneurysm indicated elective surgical repair
Key exclusion criteria
1) Under 20 years-old
2) Contraindication for MRI
3) Claustrophobia
4) Allergy to SPIO
5) Pregnant women
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Goto |
Organization
Tohoku University Hospital
Division name
Division of Advanced Surgical Science and Technology
Zip code
Address
Seiryo-machi 1-1 Aobaku Sendai, Miyagi
TEL
022-717-7214
h-goto@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Goto |
Organization
Tohoku University Hospital
Division name
Division of Advanced Surgical Science and Technology
Zip code
Address
Seiryo-machi 1-1 Aobaku Sendai, Miyagi
TEL
022-717-7214
Homepage URL
h-goto@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital, Division of Advanced Surgical Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 15 | 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
| 2016 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 20 | 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
| 2016 | Year | 05 | Month | 15 | Day |
Last modified on
| 2016 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025676
