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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: gadofosveset


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.03 mmol/kg<br>FDA-approved dose for lower extremity arterial imaging | Drug: gadofosveset<br>* Intravenous administration of the specified dosage of gadolinium contrast agent<br>* Other names: Ablavar;|
| Experimental: 0.02 mmol/kg<br> | Drug: gadofosveset<br>* Intravenous administration of the specified dosage of gadolinium contrast agent<br>* Other names: Ablavar;|
| Experimental: 0.01 mmol/kg<br> | Drug: gadofosveset<br>* Intravenous administration of the specified dosage of gadolinium contrast agent<br>* Other names: Ablavar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging Quality Score | 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: poor / nondiagnostic adequate good excellent | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Analysis Noise Ratios | 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. | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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central veins, thorax, superior vena cava, Central vein imaging