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

This study has been completed.
Sponsor:
Collaborator:
Lantheus Medical Imaging
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01431300
First received: September 7, 2011
Last updated: October 20, 2013
Last verified: August 2013
  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:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Imaging Quality Score [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

    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:
  • Quantitative Analysis Noise Ratios [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

    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.



Enrollment: 30
Study Start Date: August 2011
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01431300     History of Changes
Other Study ID Numbers: Pro00022334, CG 10011
Study First Received: September 7, 2011
Results First Received: August 1, 2013
Last Updated: October 20, 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 July 26, 2014