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

September 7, 2011
October 20, 2013
August 2011
July 2012   (final data collection date for primary outcome measure)
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
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
Complete list of historical versions of study NCT01431300 on ClinicalTrials.gov Archive Site
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.

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
Not Provided
Not Provided
 
Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Healthy
Drug: gadofosveset
Intravenous administration of the specified dosage of gadolinium contrast agent
Other Name: Ablavar
  • Active Comparator: 0.03 mmol/kg
    FDA-approved dose for lower extremity arterial imaging
    Intervention: Drug: gadofosveset
  • Experimental: 0.02 mmol/kg
    Intervention: Drug: gadofosveset
  • Experimental: 0.01 mmol/kg
    Intervention: Drug: gadofosveset
Kim CY, Heye T, Bashir MR, Gebhard TA, Merkle EM. Gadofosveset-enhanced magnetic resonance angiography of the thoracic vasculature in the equilibrium phase: feasibility and impact of dose. J Comput Assist Tomogr. 2013 Sep-Oct;37(5):732-6. doi: 10.1097/RCT.0b013e318299dde9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2013
July 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01431300
Pro00022334, CG 10011
No
Duke University
Duke University
Lantheus Medical Imaging
Principal Investigator: Charles Y Kim, MD Duke University
Duke University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP