UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The evaluation of the macrophage localization in the abdominal aortic aneurysm by SPIO enhanced MRI
Title of the study (Brief title)	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	Hitoshi Goto
Organization	Tohoku University Hospital
Division name	Division of Advanced Surgical Science and Technology
Address	Seiryo-machi 1-1 Aobaku Sendai, Miyagi
TEL	022-717-7214
Email	h-goto@med.tohoku.ac.jp

Public contact
Name of contact person	Hitoshi Goto
Organization	Tohoku University Hospital
Division name	Division of Advanced Surgical Science and Technology
Address	Seiryo-machi 1-1 Aobaku Sendai, Miyagi
TEL	022-717-7214
Homepage URL
Email	h-goto@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital, Division of Advanced Surgical Science and Technology
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 05 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025676