Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants

Duke University

Status: Completed

Conditions: Healthy

Treatments: Drug: gadofosveset

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01431300

Pro00022334

CG 10011 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to assess the image quality of Ablavar-enhanced MR angiography of the central veins of the chest, and to determine whether dose reduction can be performed while maintaining image quality. This will be a prospective randomized study, in which healthy volunteers will be recruited to undergo a central veins magnetic resonance angiogram (MRA). They will receive either the FDA-approved dose or a lower dose of Ablavar. Quantitative and qualitative analysis will be performed on the images.

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy male or female subjects between 18-45 years of age

Exclusion criteria

• Pregnant and lactating females
• known renal impairment
• allergy to gadolinium-based contrast
• metallic implanted devices
• claustrophobia.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

0.03 mmol/kg

Active Comparator group

Description:

FDA-approved dose for lower extremity arterial imaging

Treatment:

Drug: gadofosveset

0.02 mmol/kg

Experimental group

Treatment:

Drug: gadofosveset

0.01 mmol/kg

Experimental group

Treatment:

Drug: gadofosveset