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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).
This was a Phase 2, open-label, randomized, multicenter study to evaluate the efficacy and safety of a single administration of intravenous (IV) ferumoxytol at 3 dose levels as a VE-MRI imaging agent to facilitate detection of arterial stenosis in subjects with PAD. Eligible subjects were already scheduled for DSA to be completed within 14 days of the MR assessments. Nineteen sites randomized subjects in the study. The sites were selected such that an equal number of subjects could be scanned on the 3 major MRI 1.5 T platforms (Siemens, General Electric, and Philips).
Subjects were stratified by imaging platform and randomized to receive 1.0, 2.5, or 4.0 mg/kg IV ferumoxytol. On the same study day, subjects first underwent a noncontrast MRA, followed by administration of the randomized ferumoxytol dose and VE-MRI. Within 2 weeks subjects then underwent the previously scheduled DSA of the aortoiliac and superficial femoral arteries that served as the reference "gold standard."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 1.0 mg/kg IV ferumoxytol versus non-contrast MRA |
|
| Cohort 2 | Experimental | 2.5 mg/kg IV ferumoxytol versus non-contrast MRA |
|
| Cohort 3 | Experimental | 4.0 mg/kg IV ferumoxytol versus non-contrast MRA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ferumoxytol | Drug | 1.0 mg/kg IV ferumoxytol |
| |
| ferumoxytol |
| Measure | Description | Time Frame |
|---|---|---|
| Segment-level Sensitivity and Specificity of VE-MRI at 3 Ferumoxytol Dosing Levels and Differences in Sensitivity and Specificity by Dose Group | Analysis of the sensitivity and specificity of VE-MRI by dose group was performed on the ITD segments by 3 Readers. The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms. | 3 weeks |
| Segment-level Sensitivity and Specificity of Noncontrast MRA at 3 Ferumoxytol Dosing Levels and Difference From Sensitivity by Dose Group | Analysis of the sensitivity and specificity of noncontrast MRA by dose group was performed on the ITD segments by 3 Readers. The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms. The data were pooled across all imaging platforms. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Segment-level Positive and Negative Predictive Values of VE-MRI Using Ferumoxytol at 3 Dosing Levels | The sensitivity and specificity estimated by imaging platforms and dose group by imaging platforms will be reported and statistical tests of whether sensitivity/specificity differs by imaging platforms will be done. The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Strauss, MD | AMAG Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexington | Massachusetts | 02421 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Dose 1 versus non-contrast MRA ferumoxytol: Dose 1 versus non-contrast MRA |
| FG001 | Cohort 2 | Dose 2 versus non-contrast MRA ferumoxytol: Dose 2 versus non-contrast MRA |
| FG002 | Cohort 3 | Dose 3 versus non-contrast MRA ferumoxytol: Dose 3 versus non-contrast MRA |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Dose 1 versus non-contrast MRA ferumoxytol: Dose 1 versus non-contrast MRA |
| BG001 | Cohort 2 | Dose 2 versus non-contrast MRA ferumoxytol: Dose 2 versus non-contrast MRA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Segment-level Sensitivity and Specificity of VE-MRI at 3 Ferumoxytol Dosing Levels and Differences in Sensitivity and Specificity by Dose Group | Analysis of the sensitivity and specificity of VE-MRI by dose group was performed on the ITD segments by 3 Readers. The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms. | Posted | Number | 95% Confidence Interval | percent agreement | 3 weeks |
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Dose 1 versus non-contrast MRA ferumoxytol: Dose 1 versus non-contrast MRA |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Interest | Covis Pharma | 1-877-374-4177 | CTInterest@covispharma.com |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D052203 | Ferrosoferric Oxide |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005296 | Ferrous Compounds |
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| Drug |
2.5 mg/kg IV ferumoxytol |
|
| ferumoxytol | Drug | 4.0 mg/kg IV ferumoxytol |
|
| 3 weeks |
| Segment-level Positive and Negative Predictive Values of Noncontrast MRA | The sensitivity and specificity estimated by imaging platforms and dose group by imaging platforms will be reported and statistical tests of whether sensitivity/specificity differs by imaging platforms will be done. The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms. | 3 weeks |
| Segment-level Total Percent, Positive Percent Between VE-MRI and Noncontrast MRA | The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms. | 3 weeks |
| Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers | The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms. | 3 weeks |
| Segment-level Negative Percent Agreements VE-MRI and Noncontrast MRA | The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms. | 3 weeks |
| Segment-level Total Percent, Kappa Statistics Between VE-MRI and Noncontrast MRA | The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms. | 3 weeks |
| BG002 | Cohort 3 | Dose 3 versus non-contrast MRA ferumoxytol: Dose 3 versus non-contrast MRA |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Cohort 2 |
Dose 2 versus non-contrast MRA 2.5 mg/kg IV ferumoxytol versus non-contrast MRA |
| OG002 | Cohort 3 | Dose 3 versus non-contrast MRA 4.0 mg/kg IV ferumoxytol versus non-contrast MRA |
|
|
| Primary | Segment-level Sensitivity and Specificity of Noncontrast MRA at 3 Ferumoxytol Dosing Levels and Difference From Sensitivity by Dose Group | Analysis of the sensitivity and specificity of noncontrast MRA by dose group was performed on the ITD segments by 3 Readers. The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms. The data were pooled across all imaging platforms. | Posted | Number | 95% Confidence Interval | percentage | 3 weeks |
|
|
|
| Secondary | Segment-level Positive and Negative Predictive Values of VE-MRI Using Ferumoxytol at 3 Dosing Levels | The sensitivity and specificity estimated by imaging platforms and dose group by imaging platforms will be reported and statistical tests of whether sensitivity/specificity differs by imaging platforms will be done. The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms. | Posted | Number | 95% Confidence Interval | Percentage | 3 weeks |
|
|
|
| Secondary | Segment-level Positive and Negative Predictive Values of Noncontrast MRA | The sensitivity and specificity estimated by imaging platforms and dose group by imaging platforms will be reported and statistical tests of whether sensitivity/specificity differs by imaging platforms will be done. The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms. | Posted | Number | 95% Confidence Interval | Percentage | 3 weeks |
|
|
|
| Secondary | Segment-level Total Percent, Positive Percent Between VE-MRI and Noncontrast MRA | The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms. | Posted | Number | Percentage | 3 weeks |
|
|
|
|
| Secondary | Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers | The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms. | Posted | Number | 95% Confidence Interval | Percentage | 3 weeks |
|
|
|
| Secondary | Segment-level Negative Percent Agreements VE-MRI and Noncontrast MRA | The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms. | Posted | Number | Percentage | 3 weeks |
|
|
|
|
| Secondary | Segment-level Total Percent, Kappa Statistics Between VE-MRI and Noncontrast MRA | The per reader comparison of VE-MRI sensitivity and noncontrast MRA sensitivity will take into account that readings are correlated because each subject (and segments) undergo both VE-MRI and noncontrast MRA scans. The differences between ferumoxytol dose groups for the difference between VE-MRI and noncontrast MRA will be reported. The data were pooled across all imaging platforms. | Posted | Number | Kappa | 3 weeks |
|
|
|
|
| 0 |
| 40 |
| 5 |
| 40 |
| 2 |
| 40 |
| EG001 | Cohort 2 | Dose 2 versus non-contrast MRA ferumoxytol: Dose 2 versus non-contrast MRA | 0 | 39 | 2 | 39 | 0 | 39 |
| EG002 | Cohort 3 | Dose 3 versus non-contrast MRA ferumoxytol: Dose 3 versus non-contrast MRA | 0 | 40 | 4 | 40 | 0 | 40 |
| Bradycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Femoral Artery Occlusion | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Intermittent Claudication | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D008903 |
| Minerals |
|
| Reader 2: Sensitivity |
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| Reader 2: Specificity |
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| Reader 3: Sensitivity |
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| Reader 3: Specificity |
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| Reader 1: Negative Predictive Values |
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| Reader 2: Positive Predictive Values |
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| Reader 2: Negative Predictive Values |
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| Reader 3: Positive Predictive Values |
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| Reader 3: Negative Predictive Values |
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| Reader 1: Negative Predictive Values |
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| Reader 2: Positive Predictive Values |
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| Reader 2: Negative Predictive Values |
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| Reader 3: Positive Predictive Values |
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| Reader 3: Negative Predictive Values |
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| Reader 3: Positive Agreement |
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| GE - Reader 2: Sensitivity |
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| GE - Reader 2: Specificity |
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| GE - Reader 3: Sensitivity |
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| GE - Reader 3: Specificity |
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| Phillips - Reader 1: Sensitivity |
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| Phillips - Reader 1: Specificity |
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| Phillips - Reader 2: Sensitivity |
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| Phillips - Reader 2: Specificity |
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| Phillips - Reader 3: Sensitivity |
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| Phillips - Reader 3: Specificity |
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| Siemens - Reader 1: Sensitivity |
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| Siemens - Reader 1: Specificity |
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| Siemens - Reader 2: Sensitivity |
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| Siemens - Reader 2: Specificity |
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| Siemens - Reader 3: Sensitivity |
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| Siemens - Reader 3: Specificity |
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| Reader 3: Negative Agreement |
|
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| Reader 3: Kappa Statistic |
|