18 and older, any sex, with Peripheral Arterial Disease (PAD). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Segment-level Sensitivity and Specificity of VE-MRI at 3 Ferumoxytol Dosing Levels and Differences in Sensitivity and Specificity by Dose GroupPrimary· 3 weeks
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.
Reader 1: Sensitivity
Group
Value
95% CI
Cohort 1
71.8
61.3 – 82.4
Cohort 2
76.8
65.8 – 87.8
Cohort 3
81.8
71.2 – 92.5
Reader 1: Specificity
Group
Value
95% CI
Cohort 1
71.2
59.7 – 82.8
Cohort 2
76.5
66.6 – 86.4
Cohort 3
75.2
66.3 – 84.1
Reader 2: Sensitivity
Group
Value
95% CI
Cohort 1
74.6
63.1 – 86.2
Cohort 2
82.6
73.0 – 92.2
Cohort 3
71.2
58.2 – 84.3
Reader 2: Specificity
Group
Value
95% CI
Cohort 1
66.4
55.2 – 77.7
Cohort 2
77.2
68.6 – 85.7
Cohort 3
61.7
51.3 – 72.1
Reader 3: Sensitivity
Group
Value
95% CI
Cohort 1
90.1
81.9 – 98.4
Cohort 2
87.0
77.4 – 96.5
Cohort 3
86.4
76.6 – 96.2
Reader 3: Specificity
Group
Value
95% CI
Cohort 1
59.6
48.4 – 70.7
Cohort 2
70.5
60.3 – 80.6
Cohort 3
61.0
50.4 – 71.6
Segment-level Sensitivity and Specificity of Noncontrast MRA at 3 Ferumoxytol Dosing Levels and Difference From Sensitivity by Dose GroupPrimary· 3 weeks
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.
Reader 1: Sensitivity
Group
Value
95% CI
Cohort 1
49.3
34.2 – 64.4
Cohort 2
53.6
38.0 – 69.3
Cohort 3
50.0
34.3 – 65.7
Reader 1: Specificity
Group
Value
95% CI
Cohort 1
54.1
42.8 – 65.4
Cohort 2
46.3
32.6 – 60.0
Cohort 3
54.6
40.0 – 69.3
Reader 2: Sensitivity
Group
Value
95% CI
Cohort 1
63.4
50.9 – 75.8
Cohort 2
58.0
43.5 – 72.5
Cohort 3
54.5
40.0 – 69.1
Reader 2: Specificity
Group
Value
95% CI
Cohort 1
54.8
41.6 – 68.0
Cohort 2
47.7
33.7 – 61.6
Cohort 3
56.7
43.6 – 69.9
Reader 3: Sensitivity
Group
Value
95% CI
Cohort 1
76.1
65.1 – 87.0
Cohort 2
76.8
64.6 – 89.0
Cohort 3
69.7
56.1 – 83.3
Reader 3: Specificity
Group
Value
95% CI
Cohort 1
55.5
45.1 – 65.8
Cohort 2
57.7
46.1 – 69.3
Cohort 3
63.8
53.3 – 74.4
Segment-level Positive and Negative Predictive Values of VE-MRI Using Ferumoxytol at 3 Dosing LevelsSecondary· 3 weeks
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
Reader 1: Positive Predictive Values
Group
Value
95% CI
Cohort 1
54.8
40.8 – 68.9
Cohort 2
60.2
45.8 – 74.7
Cohort 3
60.7
50.5 – 70.9
Reader 1: Negative Predictive Values
Group
Value
95% CI
Cohort 1
83.9
76.4 – 91.3
Cohort 2
87.7
81.6 – 93.8
Cohort 3
89.8
83.9 – 95.8
Reader 2: Positive Predictive Values
Group
Value
95% CI
Cohort 1
52.0
38.7 – 65.2
Cohort 2
62.6
49.5 – 75.8
Cohort 3
46.5
32.2 – 57.9
Reader 2: Negative Predictive Values
Group
Value
95% CI
Cohort 1
84.3
76.8 – 91.9
Cohort 2
90.6
84.5 – 96.6
Cohort 3
82.1
73.7 – 90.5
Reader 3: Positive Predictive Values
Group
Value
95% CI
Cohort 1
52.0
40.4 – 63.7
Cohort 2
57.7
46.2 – 69.2
Cohort 3
50.0
40.5 – 61.3
Reader 3: Negative Predictive Values
Group
Value
95% CI
Cohort 1
92.6
86.4 – 98.7
Cohort 2
92.1
85.5 – 98.7
Cohort 3
90.5
83.8 – 97.3
Segment-level Positive and Negative Predictive Values of Noncontrast MRASecondary· 3 weeks
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
Reader 1: Positive Predictive Values
Group
Value
95% CI
Cohort 1
34.3
21.7 – 46.9
Cohort 2
31.6
19.7 – 43.5
Cohort 3
34.0
20.3 – 47.8
Reader 1: Negative Predictive Values
Group
Value
95% CI
Cohort 1
68.7
58.4 – 79.0
Cohort 2
68.3
56.4 – 80.2
Cohort 3
70.0
59.9 – 80.1
Reader 2: Positive Predictive Values
Group
Value
95% CI
Cohort 1
40.5
27.7 – 53.4
Cohort 2
33.9
22.4 – 45.4
Cohort 3
37.1
24.3 – 49.9
Reader 2: Negative Predictive Values
Group
Value
95% CI
Cohort 1
75.5
64.7 – 86.2
Cohort 2
71.0
59.5 – 82.5
Cohort 3
72.7
63.5 – 82.0
Reader 3: Positive Predictive Values
Group
Value
95% CI
Cohort 1
45.4
33.5 – 57.3
Cohort 2
45.7
32.8 – 58.6
Cohort 3
47.4
35.8 – 59.0
Reader 3: Negative Predictive Values
Group
Value
95% CI
Cohort 1
82.7
74.5 – 90.8
Cohort 2
84.3
75.5 – 93.1
Cohort 3
81.8
73.5 – 90.1
Segment-level Total Percent, Positive Percent Between VE-MRI and Noncontrast MRASecondary· 3 weeks
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.
Reader 1: Positive Agreement
Group
Value
95% CI
Cohort 1
46.5
Cohort 2
46.4
Cohort 3
45.5
Reader 2: Positive Agreement
Group
Value
95% CI
Cohort 1
47.9
Cohort 2
53.6
Cohort 3
48.5
Reader 3: Positive Agreement
Group
Value
95% CI
Cohort 1
71.8
Cohort 2
73.9
Cohort 3
62.1
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent ReadersSecondary· 3 weeks
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.
GE - Reader 1: Sensitivity
Group
Value
95% CI
Cohort 1
74.2
55.6 – 92.8
Cohort 2
69.2
44.9 – 93.5
Cohort 3
78.3
55.1 – 100.0
GE - Reader 1: Specificity
Group
Value
95% CI
Cohort 1
58.7
38.5 – 78.9
Cohort 2
69.6
46.4 – 92.7
Cohort 3
70.0
54.6 – 85.4
GE - Reader 2: Sensitivity
Group
Value
95% CI
Cohort 1
74.2
52.9 – 95.5
Cohort 2
84.6
65.7 – 100.0
Cohort 3
91.3
78.3 – 100.0
GE - Reader 2: Specificity
Group
Value
95% CI
Cohort 1
58.7
37.8 – 79.6
Cohort 2
76.1
59.4 – 92.8
Cohort 3
54.0
35.0 – 73.0
GE - Reader 3: Sensitivity
Group
Value
95% CI
Cohort 1
90.3
75.1 – 100.0
Cohort 2
96.2
87.9 – 100.0
Cohort 3
82.6
62.0 – 100.0
GE - Reader 3: Specificity
Group
Value
95% CI
Cohort 1
41.3
17.5 – 65.1
Cohort 2
67.4
45.4 – 89.4
Cohort 3
44.0
25.9 – 62.1
Phillips - Reader 1: Sensitivity
Group
Value
95% CI
Cohort 1
55.6
33.5 – 77.6
Cohort 2
76.2
57.3 – 95.1
Cohort 3
81.0
58.1 – 100.0
Phillips - Reader 1: Specificity
Group
Value
95% CI
Cohort 1
85.7
74.1 – 97.3
Cohort 2
76.3
59.7 – 92.9
Cohort 3
88.5
78.5 – 98.4
Segment-level Negative Percent Agreements VE-MRI and Noncontrast MRASecondary· 3 weeks
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.
Reader 1: Negative Agreement
Group
Value
95% CI
Cohort 1
25.4
Cohort 2
15.9
Cohort 3
13.6
Reader 2: Negative Agreement
Group
Value
95% CI
Cohort 1
9.9
Cohort 2
13.0
Cohort 3
22.7
Reader 3: Negative Agreement
Group
Value
95% CI
Cohort 1
5.6
Cohort 2
10.1
Cohort 3
6.1
Segment-level Total Percent, Kappa Statistics Between VE-MRI and Noncontrast MRASecondary· 3 weeks
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.
Reader 1: Kappa Statistic
Group
Value
95% CI
Cohort 1
0.440
Cohort 2
0.216
Cohort 3
0.182
Reader 2: Kappa Statistic
Group
Value
95% CI
Cohort 1
0.027
Cohort 2
0.256
Cohort 3
0.401
Reader 3: Kappa Statistic
Group
Value
95% CI
Cohort 1
0.225
Cohort 2
0.472
Cohort 3
0.108
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AMAG Pharmaceuticals, Inc.
Last refreshed: 16 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00707876.