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

October 20, 2013 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 0.03 mmol/kg
FDA-approved dose for lower extremity arterial imaging
Drug: gadofosveset
Intravenous administration of the specified dosage of gadolinium contrast agent
Other Names:
  • Ablavar
Experimental: 0.02 mmol/kg
Drug: gadofosveset
Intravenous administration of the specified dosage of gadolinium contrast agent
Other Names:
  • Ablavar
Experimental: 0.01 mmol/kg
Drug: gadofosveset
Intravenous administration of the specified dosage of gadolinium contrast agent
Other Names:
  • Ablavar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  1. poor / nondiagnostic
  2. adequate
  3. good
  4. excellent
14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Lantheus Medical Imaging

Investigators

  • Principal Investigator: Charles Y Kim, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

September 7, 2011

First Submitted That Met QC Criteria

September 8, 2011

First Posted (Estimate)

September 9, 2011

Study Record Updates

Last Update Posted (Estimate)

December 10, 2013

Last Update Submitted That Met QC Criteria

October 20, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00022334
  • CG 10011 (Other Grant/Funding Number: Lantheus Medical Imaging)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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