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

Efficacy of Gadoterate Meglumine in Diagnosis of Vascular Diseases Using 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.

Study Overview

• Status: Completed
• Conditions: Vascular Diseases
• Intervention / Treatment: Diagnostic test: Dotarem

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.

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Yasmeen Khan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

qualifying MRA

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
2x dose of Dotarem; qualifying MRA	Diagnostic test: Dotarem; (Dotarem) (0.4 ml/kg (0.2 mmol/kg))

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of MRA image quality	assess the image quality of MRA studies acquired using these two contrast	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of MRA accuracy	Assess the accuracy of MRA studies acquired using these two contrast	18 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: James Carr, Northwestern University

Publications and helpful links

General Publications

• Eng J. Sample size estimation: how many individuals should be studied? Radiology. 2003 May;227(2):309-13. doi: 10.1148/radiol.2272012051.
• Seeger A, Kramer U, Fenchel M, Grimm F, Bretschneider C, Doring J, Klumpp B, Tepe G, Rittig K, Seidensticker PR, Claussen CD, Miller S. Comparison between a linear versus a macrocyclic contrast agent for whole body MR angiography in a clinical routine setting. J Cardiovasc Magn Reson. 2008 Dec 30;10(1):63. doi: 10.1186/1532-429X-10-63.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: STU00205041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No