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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: gadofosveset

• Registration Number: NCT01431300
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-07
• Study First Submitted QC: 2011-09-08
• Study First Posted: 2011-09-09
• Primary Completion: 2012-07
• Study Completion: 2013-07
• Status Verified: 2013-08
• Results First Submitted: 2013-08-01
• Results First Submitted QC: 2013-10-20
• Last Update Submitted: 2013-10-20
• Results First Posted: 2013-12-10
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.03 mmol/kg	gadofosveset	FDA-approved dose for lower extremity arterial imaging
0.02 mmol/kg	gadofosveset	-
0.01 mmol/kg	gadofosveset	-

Primary Outcome Measures

Name	Time	Method
Imaging Quality Score	14 weeks	Two radiologists assessed imaging quality of each central venous segment for each patient, in order to compare imaging quality between each of the three doses administered. The visualization score for each venous segments was as follows: 1. poor / nondiagnostic; 2. adequate; 3. good; 4. excellent

Secondary Outcome Measures

Name	Time	Method
Quantitative Analysis Noise Ratios	14 weeks	Signal-to-noise and contrast-to-noise ratios were calculated for each central venous segment, to determine the magnitude of difference in each of the three administered doses. The ratio's were calculated as follows: Signal-to-noise ratio: signal intensity of vessel segment / standard deviation of signal intensity of the background.; Contrast-to-noise ratio = (signal intensity of vessel segment minus signal intensity of adjacent muscle) / standard deviation of signal intensity of the background.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States