UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020621
Receipt number 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 21:23:23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Nara Medical University

Institute

Department

Personal name



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

Value
https://center6.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