Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants
Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: gadofosveset (Drug)
Phase: N/A
Status: Completed
Sponsored by: Duke University Official(s) and/or principal investigator(s):
Charles Y Kim, MD, Principal Investigator, Affiliation: Duke University
Summary
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.
Clinical Details
Official title: Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
Primary outcome: Imaging Quality Score
Secondary outcome: Quantitative Analysis Noise Ratios
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.
Locations and Contacts
Duke University Medical Center, Durham, North Carolina 27710, United States
Additional Information
Starting date: August 2011
Last updated: October 20, 2013
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