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

Tracking Information

First Received Date ^ICMJE

September 7, 2011

Last Updated Date

January 31, 2013

Start Date ^ICMJE

August 2011

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01431300 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: gadofosveset

Intravenous administration of the specified dosage of gadolinium contrast agent

Other Name: Ablavar

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01431300

Other Study ID Numbers ^ICMJE

Pro00022334, CG 10011

Has Data Monitoring Committee

Responsible Party

Duke University

Study Sponsor ^ICMJE

Duke University

Collaborators ^ICMJE

Lantheus Medical Imaging

Investigators ^ICMJE

Principal Investigator:

Charles Y Kim, MD

Duke University

Information Provided By

Duke University

Verification Date

January 2013

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

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