Unique ID issued by UMIN | UMIN000020621 |
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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 |
Endoleak detection by super paramagnetic iron oxide-enhanced dynamic magnetic resonance imaging
Endoleak detection by SPIO enhanced MRI
Endoleak detection by super paramagnetic iron oxide-enhanced dynamic magnetic resonance imaging
Endoleak detection by SPIO enhanced MRI
Japan |
Abdominal aortic aneurysm
Vascular surgery | Radiology |
Others
NO
To examine SPIO-enhanced dynamic MRI as a potential alternative to CE-CT for detection of endoleaks after EVAR.
Safety,Efficacy
Intra/inter-observer agreement, Inter-modality agreement
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Medicine |
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).
Not applicable |
Not applicable |
Male and Female
Patients in whom nitinol endograft was implanted
Patients in whom stainless steel endograft was implanted
Patients who cannot receive contrast enhanced CT scan
25
1st name | |
Middle name | |
Last name | Shigeo Ichihashi |
Nara Medical University
Radiology
840, Shijyocho, Kashihara, Nara
0744-29-8900
ichihash@naramed-u.ac.jp
1st name | |
Middle name | |
Last name | Shigeo Ichihashi |
Nara Medical University
Radiology
840, Shijyocho, Kashihara, Nara
0744-29-8900
ichihash@naramed-u.ac.jp
Nara Medical University
Nara Medical University
Other
NO
2016 | Year | 01 | Month | 19 | Day |
Published
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).
Completed
2011 | Year | 07 | Month | 01 | Day |
2011 | Year | 07 | Month | 21 | Day |
2013 | Year | 02 | Month | 15 | Day |
2013 | Year | 02 | Month | 15 | Day |
2013 | Year | 02 | Month | 15 | Day |
2013 | Year | 02 | Month | 15 | Day |
2016 | Year | 01 | Month | 18 | Day |
2016 | Year | 01 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023737
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