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

NCT05199792 | Completed

• 1 other identifier: STU00205041
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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. 1.Carotid, chest, and abdomenal MRA with gadoterate meglumine has a comparable image quality and diagnostic confidence to MRA using gadobutrol.
2. 2.Carotid, chest, and abdomenal MRA with gadoterate meglumine has a comparable accuracy for vascular lesion and stenosis detection compared to MRA using gadobutrol.

Conditions

Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• Assessment of MRA image quality

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

  18 months

Secondary Outcomes (1)

• Assessment of MRA accuracy

  18 months

Study Arms (1)

2x dose of Dotarem

qualifying MRA

Diagnostic Test: Dotarem

Interventions

Dotarem DIAGNOSTIC_TEST

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

2x dose of Dotarem

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

qualifying MRA

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Yasmeen Khan

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• Eng J. Sample size estimation: how many individuals should be studied? Radiology. 2003 May;227(2):309-13. doi: 10.1148/radiol.2272012051.

  PMID: 12732691 BACKGROUND

• 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.

  PMID: 19116027 RESULT

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• James Carr

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 20, 2022
• Study Start: June 2, 2017
• Primary Completion: December 31, 2019
• Study Completion: January 1, 2020
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)