Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)

• Sponsor: AMAG Pharmaceuticals, Inc. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT00707876
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Arms: 3
• Duration (Months): 131
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease (PAD)	Drug: ferumoxytol; Drug: ferumoxytol; Drug: ferumoxytol	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Phase II, Open Label, Randomized, Multicenter Trial Comparing Noncontrast MRA Versus Ferumoxytol Vascular Enhanced MRI (VE-MRI) for the Detection of Clinically Significant Stenosis or Occlusion of the Aortoiliac and Superficial Femoral Arteries in Subjects With Peripheral Arterial Disease Scheduled for Digital Subtraction Angiography (DSA)
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Jul 1, 2010
• Anticipated Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Dose 1 versus non-contrast MRA	Drug: ferumoxytol; Dose 1 versus non-contrast MRA
Experimental: 2 Dose 2 versus non-contrast MRA	Drug: ferumoxytol; Dose 2 versus non-contrast MRA
Experimental: 3 Dose 3 versus non-contrast MRA	Drug: ferumoxytol; Dose 3 versus non-contrast MRA

Outcome Measures

Primary Outcome Measures

1. To assess sensitivity and specificity of non-contrast MRA and VE-MRI at three ferumoxytol dosing levels [3 weeks]

Secondary Outcome Measures

1. To assess positive and negative predictive values of VE-MRI using ferumoxytol at different dosing levels. [3 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects with symptoms of PAD

• Scheduled for DSA

Exclusion Criteria:

• Critical leg ischemia manifested by ulcers, gangrene or leg amputation

• Laboratory evidence of iron overload, liver disease, pregnancy

• History of allergy to or recent exposure to radiocontrast, gadolinium chelates, or intravenous iron therapy

• Clinical concerns about co-morbidities, subject suitability

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Lexington	Massachusetts	United States	02421

Sponsors and Collaborators

• AMAG Pharmaceuticals, Inc.

Investigators

• Study Director: William Strauss, MD, AMAG Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AMAG Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT00707876
• Other Study ID Numbers: FER-PAD-001
• First Posted: Jul 1, 2008
• Last Update Posted: Apr 26, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by AMAG Pharmaceuticals, Inc.: Peripheral arterial disease (PAD); Magnetic Resonance Angiography (MRA); Magnetic Resonance Imaging (MRI), imaging agent or biomarker
• Additional relevant MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Ferrosoferric Oxide

Study Results

No Results Posted as of Apr 26, 2019