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OpenTrials
Completed

NCT Number: NCT05199792

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

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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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yasmeen Khan

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dotarem

Diagnostic Test

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

Primary outcomes

  1. Assessment of MRA image quality

    Time frame: 18 months

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

Secondary outcomes

  1. Assessment of MRA accuracy

    Time frame: 18 months

    Assess the accuracy of MRA studies acquired using these two contrast

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Efficacy of Gadoterate Meglumine in Diagnosis of Vascular Diseases Using MRA

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jan 20, 2022
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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