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1 for Peripheral Arterial Disease
Phase 2
Waitlist Available
Research Sponsored by AMAG Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights
Study Summary
The purpose of this study is to compare the difference between two magnetic resonance imaging (MRI) techniques for visualizing arteries. The study hypothesizes that one method that relies upon imaging flowing blood in the pelvic and leg arteries will not be as accurate or efficient as injecting a safe imaging agent to change the appearance of the blood on the MRI. Both methods will be compared with Digital Subtraction Angiography (DSA).
Eligible Conditions
- Peripheral Arterial Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess sensitivity and specificity of non-contrast MRA and VE-MRI at three ferumoxytol dosing levels
Secondary outcome measures
To assess positive and negative predictive values of VE-MRI using ferumoxytol at different dosing levels.
Trial Design
3Treatment groups
Experimental Treatment
Group I: 3Experimental Treatment1 Intervention
Dose 3 versus non-contrast MRA
Group II: 2Experimental Treatment1 Intervention
Dose 2 versus non-contrast MRA
Group III: 1Experimental Treatment1 Intervention
Dose 1 versus non-contrast MRA
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferumoxytol
FDA approved
Find a Location
Who is running the clinical trial?
AMAG Pharmaceuticals, Inc.Lead Sponsor
43 Previous Clinical Trials
11,206 Total Patients Enrolled
William Strauss, MDStudy DirectorAMAG Pharmaceuticals, Inc.
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