Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-27 @ 10:00 AM
Study NCT ID:
NCT05199792
Status:
COMPLETED
Last Update Posted:
2022-01-20
First Post:
2021-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Gadoterate Meglumine in Diagnosis of Vascular Diseases Using MRA MRA
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
Efficacy of Gadoterate Meglumine in Diagnosis of Vascular Diseases Using MRA
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare magnetic resonance angiography (MRA) using gadoterate meglumine to clinically obtained MRA using gadobutrol. The specific aims are to show:
1. Carotid, chest, and abdomenal MRA with gadoterate meglumine has a comparable image quality and diagnostic confidence to MRA using gadobutrol.
2. Carotid, chest, and abdomenal MRA with gadoterate meglumine has a comparable accuracy for vascular lesion and stenosis detection compared to MRA using gadobutrol.
1. Carotid, chest, and abdomenal MRA with gadoterate meglumine has a comparable image quality and diagnostic confidence to MRA using gadobutrol.
2. Carotid, chest, and abdomenal MRA with gadoterate meglumine has a comparable accuracy for vascular lesion and stenosis detection compared to MRA using gadobutrol.
Detailed Description:
In this study, we will assess the image quality and accuracy of MRA studies acquired using these two contrast agents. In the cases where Digital Subtraction Angiography (DSA) or CT angiography images are available, the results of the study using both contrast agents will be compared to the DSA or CTA findings. All MRA images will be assessed independently by two readers. The readers will be blinded to the clinical symptoms, contrast agent and DSA/CTA results. A five-level system rating for image quality of each arterial segment will be used (1 = non-diagnostic images, 2 = poor image quality, significant blurring/artefacts, diagnosis suspected but not established, 3 = fair quality with established diagnosis, 4=good quality with definite diagnosis, minimal blurring/artefacts, 5 = sharply defined borders, excellent quality image information). Vascular lesions will also be graded on a 1-5 scale. Vessel segment stenoses will be graded using a five-point grading scale as follows: (1) normal; (2) mild (\<50% diameter stenosis); (3) moderate (50% to 74%), severe (75% to 99%); and (5) total occlusion.
Grades 1 and 2 will be considered insignificant, while grades 3 to 5 will be interpreted as significant for diagnostic accuracy testing.
Grades 1 and 2 will be considered insignificant, while grades 3 to 5 will be interpreted as significant for diagnostic accuracy testing.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: