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Completed

NCT Number: NCT01431300

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

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Gadofosveset

Drug

Intravenous administration of the specified dosage of gadolinium contrast agent

Other names: Ablavar

Primary outcomes

  1. Imaging Quality Score

    Time frame: 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:

    • poor / nondiagnostic
    • adequate
    • good
    • excellent

Secondary outcomes

  1. Quantitative Analysis Noise Ratios

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Lantheus Medical Imaging

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Sep 9, 2011
Registry last updated
Dec 10, 2013

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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