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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020621
Receipt No. R000023737
Scientific Title Endoleak detection by super paramagnetic iron oxide-enhanced dynamic magnetic resonance imaging
Date of disclosure of the study information 2016/01/19
Last modified on 2016/01/18

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Basic information
Public title Endoleak detection by super paramagnetic iron oxide-enhanced dynamic magnetic resonance imaging
Acronym Endoleak detection by SPIO enhanced MRI
Scientific Title Endoleak detection by super paramagnetic iron oxide-enhanced dynamic magnetic resonance imaging
Scientific Title:Acronym Endoleak detection by SPIO enhanced MRI
Region
Japan

Condition
Condition Abdominal aortic aneurysm
Classification by specialty
Vascular surgery Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine SPIO-enhanced dynamic MRI as a potential alternative to CE-CT for detection of endoleaks after EVAR.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intra/inter-observer agreement, Inter-modality agreement
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 Administration of contrast media of super paramagnetic iron oxide (SPIO), a dose of which was 0.6-1.4 mL (0.016 mL/kg body weight).
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients in whom nitinol endograft was implanted
Key exclusion criteria Patients in whom stainless steel endograft was implanted

Patients who cannot receive contrast enhanced CT scan
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeo Ichihashi
Organization Nara Medical University
Division name Radiology
Zip code
Address 840, Shijyocho, Kashihara, Nara
TEL 0744-29-8900
Email ichihash@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeo Ichihashi
Organization Nara Medical University
Division name Radiology
Zip code
Address 840, Shijyocho, Kashihara, Nara
TEL 0744-29-8900
Homepage URL
Email ichihash@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Nara Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 01 Month 19 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
A total of 23 patients were enrolled in this study, and 11 type II endoleaks originating from either the lumbar or inferior mesenteric artery were detected.
Eight were able to be detected by CE-CT (8/11:73%) and 10 (10/11:91%) by SPIO-enhanced MRI. Interobserver
(k[0.91; 95% CI, 0.74-1.00) and intraobserver agreement for MRI (k[1.00) were excellent. Intermodality agreement for endoleak detection was moderate (k [ 0.63; 95% CI, 0.32-0.94; and k [ 0.62; 95% CI, 0.29-0.95 for observers A and B, respectively).
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
2011 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 21 Day
Last follow-up date
2013 Year 02 Month 15 Day
Date of closure to data entry
2013 Year 02 Month 15 Day
Date trial data considered complete
2013 Year 02 Month 15 Day
Date analysis concluded
2013 Year 02 Month 15 Day

Other
Other related information

Management information
Registered date
2016 Year 01 Month 18 Day
Last modified on
2016 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023737

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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