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临床试验/NCT05199792
NCT05199792已完成不适用

Efficacy of Gadoterate Meglumine in Diagnosis of Vascular Diseases Using MRA

Northwestern University1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2017年6月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
1
主要终点
Assessment of MRA image quality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female subjects 18-89 years of age
  • Suspected or diagnosed vascular disease
  • Standard of care carotid, chest, or
  • Willingness to undergo 1 research MRA with up to double dose gadoterate meglumine
  • Able to complete the MR safety questionnaire
  • Able to comprehend and provide informed consent in English

排除标准

  • • Allergy to gadolinium-containing contrast media
  • Chronic, severe kidney disease
  • eGFR < 60mL/min/1.73m2
  • Acute kidney injury
  • Kidney or liver transplant within 8 weeks
  • Contraindication to MRI (implanted device, claustrophobia, dyspnea precluding the ability to follow breath-hold instructions)
  • Pregnant or breastfeeding women
  • Adults unable to consent
  • Individual who are not yet adults
  • Prisoners

结局指标

主要结局

Assessment of MRA image quality

时间窗: 18 months

assess the image quality of MRA studies acquired using these two contrast

次要结局

  • Assessment of MRA accuracy(18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Carr

Professor

Northwestern University

研究点 (1)

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