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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Lantheus Medical Imaging
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01431300
First received: September 7, 2011
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Drug: gadofosveset

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Imaging quality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Two radiologists will assess imaging quality of each central venous segment to determine whether there is a difference between each of the three doses administered


Secondary Outcome Measures:
  • quantitative analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    signal-to-noise and contrast-to-noise ratios will be calculated for each central venous segment, to determine the magnitude of difference in each of the three administered doses


Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: July 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Ablavar
Experimental: 0.02 mmol/kg Drug: gadofosveset
Intravenous administration of the specified dosage of gadolinium contrast agent
Other Name: Ablavar
Experimental: 0.01 mmol/kg Drug: gadofosveset
Intravenous administration of the specified dosage of gadolinium contrast agent
Other Name: Ablavar

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431300

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Lantheus Medical Imaging
Investigators
Principal Investigator: Charles Y Kim, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01431300     History of Changes
Other Study ID Numbers: Pro00022334, CG 10011
Study First Received: September 7, 2011
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
central veins
thorax
superior vena cava
Central vein imaging

ClinicalTrials.gov processed this record on May 22, 2013