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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

Page last updated: August 23, 2015

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