Efficacy of Gadoterate Meglumine in Diagnosis of Vascular Diseases Using MRA MRA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-02

Study Completion Date

2020-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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2x dose of Dotarem

qualifying MRA

Dotarem

Intervention Type DIAGNOSTIC_TEST

(Dotarem) (0.4 ml/kg (0.2 mmol/kg))

Interventions

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Dotarem

(Dotarem) (0.4 ml/kg (0.2 mmol/kg))

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* • 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes