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Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)

Primary Purpose

Peripheral Arterial Disease (PAD)

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ferumoxytol

About this trial

This is an interventional diagnostic trial for Peripheral Arterial Disease (PAD) focused on measuring Peripheral arterial disease (PAD); Magnetic Resonance Angiography (MRA); Magnetic Resonance Imaging (MRI), imaging agent or biomarker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm Description

Dose 1 versus non-contrast MRA

Dose 2 versus non-contrast MRA

Dose 3 versus non-contrast MRA

Outcomes

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.

Full Information

NCT ID

NCT00707876

First Posted

June 27, 2008

Last Updated

April 25, 2019

Sponsor

AMAG Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00707876

Brief Title

Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)

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 Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 2008 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AMAG Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease (PAD)

Keywords

Peripheral arterial disease (PAD); Magnetic Resonance Angiography (MRA); Magnetic Resonance Imaging (MRI), imaging agent or biomarker

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Dose 1 versus non-contrast MRA

Arm Title

Arm Type

Experimental

Arm Description

Dose 2 versus non-contrast MRA

Arm Title

Arm Type

Experimental

Arm Description

Dose 3 versus non-contrast MRA

Intervention Type

Drug

Intervention Name(s)

ferumoxytol

Intervention Description

Dose 1 versus non-contrast MRA

Intervention Type

Drug

Intervention Name(s)

ferumoxytol

Intervention Description

Dose 2 versus non-contrast MRA

Intervention Type

Drug

Intervention Name(s)

ferumoxytol

Intervention Description

Dose 3 versus non-contrast MRA

Primary Outcome Measure Information:

Title

To assess sensitivity and specificity of non-contrast MRA and VE-MRI at three ferumoxytol dosing levels

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

To assess positive and negative predictive values of VE-MRI using ferumoxytol at different dosing levels.

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Strauss, MD

Organizational Affiliation

AMAG Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

City

Lexington

State/Province

Massachusetts

ZIP/Postal Code

02421

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)

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