Trial Outcomes & Findings for Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD) (NCT NCT00707876)
NCT ID: NCT00707876
Last Updated: 2026-04-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
119 participants
Primary outcome timeframe
3 weeks
Results posted on
2026-04-16
Participant Flow
Participant milestones
| Measure |
Cohort 1
Dose 1 versus non-contrast MRA
ferumoxytol: Dose 1 versus non-contrast MRA
|
Cohort 2
Dose 2 versus non-contrast MRA
ferumoxytol: Dose 2 versus non-contrast MRA
|
Cohort 3
Dose 3 versus non-contrast MRA
ferumoxytol: Dose 3 versus non-contrast MRA
|
|---|---|---|---|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
|
Overall Study
STARTED
|
40
|
39
|
40
|
|
Overall Study
COMPLETED
|
39
|
39
|
37
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)
Baseline characteristics by cohort
| Measure |
Cohort 1
n=40 Participants
Dose 1 versus non-contrast MRA
ferumoxytol: Dose 1 versus non-contrast MRA
|
Cohort 2
n=39 Participants
Dose 2 versus non-contrast MRA
ferumoxytol: Dose 2 versus non-contrast MRA
|
Cohort 3
n=40 Participants
Dose 3 versus non-contrast MRA
ferumoxytol: Dose 3 versus non-contrast MRA
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=193 Participants
|
18 Participants
n=193 Participants
|
17 Participants
n=386 Participants
|
52 Participants
n=13 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=193 Participants
|
21 Participants
n=193 Participants
|
23 Participants
n=386 Participants
|
67 Participants
n=13 Participants
|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 11.69 • n=193 Participants
|
64.2 years
STANDARD_DEVIATION 10.97 • n=193 Participants
|
64.5 years
STANDARD_DEVIATION 9.77 • n=386 Participants
|
65.1 years
STANDARD_DEVIATION 10.80 • n=13 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=193 Participants
|
9 Participants
n=193 Participants
|
9 Participants
n=386 Participants
|
32 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=193 Participants
|
30 Participants
n=193 Participants
|
31 Participants
n=386 Participants
|
87 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
8 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=193 Participants
|
36 Participants
n=193 Participants
|
39 Participants
n=386 Participants
|
111 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=193 Participants
|
6 Participants
n=193 Participants
|
7 Participants
n=386 Participants
|
19 Participants
n=13 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=193 Participants
|
33 Participants
n=193 Participants
|
33 Participants
n=386 Participants
|
99 Participants
n=13 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
1 Participants
n=13 Participants
|
PRIMARY outcome
Timeframe: 3 weeksAnalysis 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.
Outcome measures
| Measure |
Cohort 1
n=39 Participants
Dose 1 versus non-contrast MRA
1.0 mg/kg IV ferumoxytol versus non-contrast MRA
|
Cohort 2
n=39 Participants
Dose 2 versus non-contrast MRA
2.5 mg/kg IV ferumoxytol versus non-contrast MRA
|
Cohort 3
n=37 Participants
Dose 3 versus non-contrast MRA
4.0 mg/kg IV ferumoxytol versus non-contrast MRA
|
|---|---|---|---|
|
Segment-level Sensitivity and Specificity of VE-MRI at 3 Ferumoxytol Dosing Levels and Differences in Sensitivity and Specificity by Dose Group
Reader 1: Sensitivity
|
71.8 percent agreement
Interval 61.3 to 82.4
|
76.8 percent agreement
Interval 65.8 to 87.8
|
81.8 percent agreement
Interval 71.2 to 92.5
|
|
Segment-level Sensitivity and Specificity of VE-MRI at 3 Ferumoxytol Dosing Levels and Differences in Sensitivity and Specificity by Dose Group
Reader 1: Specificity
|
71.2 percent agreement
Interval 59.7 to 82.8
|
76.5 percent agreement
Interval 66.6 to 86.4
|
75.2 percent agreement
Interval 66.3 to 84.1
|
|
Segment-level Sensitivity and Specificity of VE-MRI at 3 Ferumoxytol Dosing Levels and Differences in Sensitivity and Specificity by Dose Group
Reader 2: Sensitivity
|
74.6 percent agreement
Interval 63.1 to 86.2
|
82.6 percent agreement
Interval 73.0 to 92.2
|
71.2 percent agreement
Interval 58.2 to 84.3
|
|
Segment-level Sensitivity and Specificity of VE-MRI at 3 Ferumoxytol Dosing Levels and Differences in Sensitivity and Specificity by Dose Group
Reader 2: Specificity
|
66.4 percent agreement
Interval 55.2 to 77.7
|
77.2 percent agreement
Interval 68.6 to 85.7
|
61.7 percent agreement
Interval 51.3 to 72.1
|
|
Segment-level Sensitivity and Specificity of VE-MRI at 3 Ferumoxytol Dosing Levels and Differences in Sensitivity and Specificity by Dose Group
Reader 3: Sensitivity
|
90.1 percent agreement
Interval 81.9 to 98.4
|
87.0 percent agreement
Interval 77.4 to 96.5
|
86.4 percent agreement
Interval 76.6 to 96.2
|
|
Segment-level Sensitivity and Specificity of VE-MRI at 3 Ferumoxytol Dosing Levels and Differences in Sensitivity and Specificity by Dose Group
Reader 3: Specificity
|
59.6 percent agreement
Interval 48.4 to 70.7
|
70.5 percent agreement
Interval 60.3 to 80.6
|
61.0 percent agreement
Interval 50.4 to 71.6
|
PRIMARY outcome
Timeframe: 3 weeksAnalysis 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.
Outcome measures
| Measure |
Cohort 1
n=39 Participants
Dose 1 versus non-contrast MRA
1.0 mg/kg IV ferumoxytol versus non-contrast MRA
|
Cohort 2
n=39 Participants
Dose 2 versus non-contrast MRA
2.5 mg/kg IV ferumoxytol versus non-contrast MRA
|
Cohort 3
n=37 Participants
Dose 3 versus non-contrast MRA
4.0 mg/kg IV ferumoxytol versus non-contrast MRA
|
|---|---|---|---|
|
Segment-level Sensitivity and Specificity of Noncontrast MRA at 3 Ferumoxytol Dosing Levels and Difference From Sensitivity by Dose Group
Reader 2: Specificity
|
54.8 percentage
Interval 41.6 to 68.0
|
47.7 percentage
Interval 33.7 to 61.6
|
56.7 percentage
Interval 43.6 to 69.9
|
|
Segment-level Sensitivity and Specificity of Noncontrast MRA at 3 Ferumoxytol Dosing Levels and Difference From Sensitivity by Dose Group
Reader 3: Sensitivity
|
76.1 percentage
Interval 65.1 to 87.0
|
76.8 percentage
Interval 64.6 to 89.0
|
69.7 percentage
Interval 56.1 to 83.3
|
|
Segment-level Sensitivity and Specificity of Noncontrast MRA at 3 Ferumoxytol Dosing Levels and Difference From Sensitivity by Dose Group
Reader 3: Specificity
|
55.5 percentage
Interval 45.1 to 65.8
|
57.7 percentage
Interval 46.1 to 69.3
|
63.8 percentage
Interval 53.3 to 74.4
|
|
Segment-level Sensitivity and Specificity of Noncontrast MRA at 3 Ferumoxytol Dosing Levels and Difference From Sensitivity by Dose Group
Reader 1: Sensitivity
|
49.3 percentage
Interval 34.2 to 64.4
|
53.6 percentage
Interval 38.0 to 69.3
|
50.0 percentage
Interval 34.3 to 65.7
|
|
Segment-level Sensitivity and Specificity of Noncontrast MRA at 3 Ferumoxytol Dosing Levels and Difference From Sensitivity by Dose Group
Reader 1: Specificity
|
54.1 percentage
Interval 42.8 to 65.4
|
46.3 percentage
Interval 32.6 to 60.0
|
54.6 percentage
Interval 40.0 to 69.3
|
|
Segment-level Sensitivity and Specificity of Noncontrast MRA at 3 Ferumoxytol Dosing Levels and Difference From Sensitivity by Dose Group
Reader 2: Sensitivity
|
63.4 percentage
Interval 50.9 to 75.8
|
58.0 percentage
Interval 43.5 to 72.5
|
54.5 percentage
Interval 40.0 to 69.1
|
SECONDARY outcome
Timeframe: 3 weeksThe 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.
Outcome measures
| Measure |
Cohort 1
n=39 Participants
Dose 1 versus non-contrast MRA
1.0 mg/kg IV ferumoxytol versus non-contrast MRA
|
Cohort 2
n=39 Participants
Dose 2 versus non-contrast MRA
2.5 mg/kg IV ferumoxytol versus non-contrast MRA
|
Cohort 3
n=37 Participants
Dose 3 versus non-contrast MRA
4.0 mg/kg IV ferumoxytol versus non-contrast MRA
|
|---|---|---|---|
|
Segment-level Positive and Negative Predictive Values of VE-MRI Using Ferumoxytol at 3 Dosing Levels
Reader 1: Positive Predictive Values
|
54.8 Percentage
Interval 40.8 to 68.9
|
60.2 Percentage
Interval 45.8 to 74.7
|
60.7 Percentage
Interval 50.5 to 70.9
|
|
Segment-level Positive and Negative Predictive Values of VE-MRI Using Ferumoxytol at 3 Dosing Levels
Reader 1: Negative Predictive Values
|
83.9 Percentage
Interval 76.4 to 91.3
|
87.7 Percentage
Interval 81.6 to 93.8
|
89.8 Percentage
Interval 83.9 to 95.8
|
|
Segment-level Positive and Negative Predictive Values of VE-MRI Using Ferumoxytol at 3 Dosing Levels
Reader 2: Positive Predictive Values
|
52.0 Percentage
Interval 38.7 to 65.2
|
62.6 Percentage
Interval 49.5 to 75.8
|
46.5 Percentage
Interval 32.2 to 57.9
|
|
Segment-level Positive and Negative Predictive Values of VE-MRI Using Ferumoxytol at 3 Dosing Levels
Reader 2: Negative Predictive Values
|
84.3 Percentage
Interval 76.8 to 91.9
|
90.6 Percentage
Interval 84.5 to 96.6
|
82.1 Percentage
Interval 73.7 to 90.5
|
|
Segment-level Positive and Negative Predictive Values of VE-MRI Using Ferumoxytol at 3 Dosing Levels
Reader 3: Positive Predictive Values
|
52.0 Percentage
Interval 40.4 to 63.7
|
57.7 Percentage
Interval 46.2 to 69.2
|
50.0 Percentage
Interval 40.5 to 61.3
|
|
Segment-level Positive and Negative Predictive Values of VE-MRI Using Ferumoxytol at 3 Dosing Levels
Reader 3: Negative Predictive Values
|
92.6 Percentage
Interval 86.4 to 98.7
|
92.1 Percentage
Interval 85.5 to 98.7
|
90.5 Percentage
Interval 83.8 to 97.3
|
SECONDARY outcome
Timeframe: 3 weeksThe 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.
Outcome measures
| Measure |
Cohort 1
n=39 Participants
Dose 1 versus non-contrast MRA
1.0 mg/kg IV ferumoxytol versus non-contrast MRA
|
Cohort 2
n=39 Participants
Dose 2 versus non-contrast MRA
2.5 mg/kg IV ferumoxytol versus non-contrast MRA
|
Cohort 3
n=37 Participants
Dose 3 versus non-contrast MRA
4.0 mg/kg IV ferumoxytol versus non-contrast MRA
|
|---|---|---|---|
|
Segment-level Positive and Negative Predictive Values of Noncontrast MRA
Reader 1: Positive Predictive Values
|
34.3 Percentage
Interval 21.7 to 46.9
|
31.6 Percentage
Interval 19.7 to 43.5
|
34.0 Percentage
Interval 20.3 to 47.8
|
|
Segment-level Positive and Negative Predictive Values of Noncontrast MRA
Reader 1: Negative Predictive Values
|
68.7 Percentage
Interval 58.4 to 79.0
|
68.3 Percentage
Interval 56.4 to 80.2
|
70.0 Percentage
Interval 59.9 to 80.1
|
|
Segment-level Positive and Negative Predictive Values of Noncontrast MRA
Reader 2: Positive Predictive Values
|
40.5 Percentage
Interval 27.7 to 53.4
|
33.9 Percentage
Interval 22.4 to 45.4
|
37.1 Percentage
Interval 24.3 to 49.9
|
|
Segment-level Positive and Negative Predictive Values of Noncontrast MRA
Reader 2: Negative Predictive Values
|
75.5 Percentage
Interval 64.7 to 86.2
|
71.0 Percentage
Interval 59.5 to 82.5
|
72.7 Percentage
Interval 63.5 to 82.0
|
|
Segment-level Positive and Negative Predictive Values of Noncontrast MRA
Reader 3: Positive Predictive Values
|
45.4 Percentage
Interval 33.5 to 57.3
|
45.7 Percentage
Interval 32.8 to 58.6
|
47.4 Percentage
Interval 35.8 to 59.0
|
|
Segment-level Positive and Negative Predictive Values of Noncontrast MRA
Reader 3: Negative Predictive Values
|
82.7 Percentage
Interval 74.5 to 90.8
|
84.3 Percentage
Interval 75.5 to 93.1
|
81.8 Percentage
Interval 73.5 to 90.1
|
SECONDARY outcome
Timeframe: 3 weeksThe 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.
Outcome measures
| Measure |
Cohort 1
n=39 Participants
Dose 1 versus non-contrast MRA
1.0 mg/kg IV ferumoxytol versus non-contrast MRA
|
Cohort 2
n=39 Participants
Dose 2 versus non-contrast MRA
2.5 mg/kg IV ferumoxytol versus non-contrast MRA
|
Cohort 3
n=37 Participants
Dose 3 versus non-contrast MRA
4.0 mg/kg IV ferumoxytol versus non-contrast MRA
|
|---|---|---|---|
|
Segment-level Total Percent, Positive Percent Between VE-MRI and Noncontrast MRA
Reader 1: Positive Agreement
|
46.5 Percentage
|
46.4 Percentage
|
45.5 Percentage
|
|
Segment-level Total Percent, Positive Percent Between VE-MRI and Noncontrast MRA
Reader 2: Positive Agreement
|
47.9 Percentage
|
53.6 Percentage
|
48.5 Percentage
|
|
Segment-level Total Percent, Positive Percent Between VE-MRI and Noncontrast MRA
Reader 3: Positive Agreement
|
71.8 Percentage
|
73.9 Percentage
|
62.1 Percentage
|
SECONDARY outcome
Timeframe: 3 weeksThe 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.
Outcome measures
| Measure |
Cohort 1
n=39 Participants
Dose 1 versus non-contrast MRA
1.0 mg/kg IV ferumoxytol versus non-contrast MRA
|
Cohort 2
n=39 Participants
Dose 2 versus non-contrast MRA
2.5 mg/kg IV ferumoxytol versus non-contrast MRA
|
Cohort 3
n=37 Participants
Dose 3 versus non-contrast MRA
4.0 mg/kg IV ferumoxytol versus non-contrast MRA
|
|---|---|---|---|
|
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
GE - Reader 1: Sensitivity
|
74.2 Percentage
Interval 55.6 to 92.8
|
69.2 Percentage
Interval 44.9 to 93.5
|
78.3 Percentage
Interval 55.1 to 100.0
|
|
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
GE - Reader 1: Specificity
|
58.7 Percentage
Interval 38.5 to 78.9
|
69.6 Percentage
Interval 46.4 to 92.7
|
70.0 Percentage
Interval 54.6 to 85.4
|
|
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
GE - Reader 2: Sensitivity
|
74.2 Percentage
Interval 52.9 to 95.5
|
84.6 Percentage
Interval 65.7 to 100.0
|
91.3 Percentage
Interval 78.3 to 100.0
|
|
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
GE - Reader 2: Specificity
|
58.7 Percentage
Interval 37.8 to 79.6
|
76.1 Percentage
Interval 59.4 to 92.8
|
54.0 Percentage
Interval 35.0 to 73.0
|
|
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
GE - Reader 3: Sensitivity
|
90.3 Percentage
Interval 75.1 to 100.0
|
96.2 Percentage
Interval 87.9 to 100.0
|
82.6 Percentage
Interval 62.0 to 100.0
|
|
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
GE - Reader 3: Specificity
|
41.3 Percentage
Interval 17.5 to 65.1
|
67.4 Percentage
Interval 45.4 to 89.4
|
44.0 Percentage
Interval 25.9 to 62.1
|
|
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
Phillips - Reader 1: Sensitivity
|
55.6 Percentage
Interval 33.5 to 77.6
|
76.2 Percentage
Interval 57.3 to 95.1
|
81.0 Percentage
Interval 58.1 to 100.0
|
|
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
Phillips - Reader 1: Specificity
|
85.7 Percentage
Interval 74.1 to 97.3
|
76.3 Percentage
Interval 59.7 to 92.9
|
88.5 Percentage
Interval 78.5 to 98.4
|
|
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
Phillips - Reader 2: Sensitivity
|
72.2 Percentage
Interval 47.4 to 97.1
|
76.2 Percentage
Interval 57.0 to 95.4
|
57.1 Percentage
Interval 29.6 to 84.7
|
|
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
Phillips - Reader 2: Specificity
|
76.8 Percentage
Interval 66.6 to 87.0
|
74.6 Percentage
Interval 61.3 to 87.9
|
75.0 Percentage
Interval 57.2 to 92.8
|
|
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
Phillips - Reader 3: Sensitivity
|
88.9 Percentage
Interval 72.7 to 100.0
|
81.0 Percentage
Interval 63.0 to 98.9
|
95.2 Percentage
Interval 85.2 to 100.0
|
|
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
Phillips - Reader 3: Specificity
|
73.2 Percentage
Interval 56.2 to 90.2
|
72.9 Percentage
Interval 55.6 to 90.2
|
84.6 Percentage
Interval 72.9 to 96.3
|
|
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
Siemens - Reader 1: Sensitivity
|
81.8 Percentage
Interval 66.9 to 96.7
|
86.4 Percentage
Interval 67.5 to 100.0
|
86.4 Percentage
Interval 70.5 to 100.0
|
|
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
Siemens - Reader 1: Specificity
|
65.9 Percentage
Interval 34.8 to 97.0
|
84.1 Percentage
Interval 67.7 to 100.0
|
64.1 Percentage
Interval 41.2 to 87.0
|
|
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
Siemens - Reader 2: Sensitivity
|
77.3 Percentage
Interval 57.5 to 97.1
|
86.4 Percentage
Interval 69.3 to 100.0
|
63.6 Percentage
Interval 38.4 to 88.8
|
|
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
Siemens - Reader 2: Specificity
|
61.4 Percentage
Interval 29.2 to 93.5
|
81.8 Percentage
Interval 62.1 to 100.0
|
53.8 Percentage
Interval 34.7 to 73.0
|
|
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
Siemens - Reader 3: Sensitivity
|
90.9 Percentage
Interval 74.8 to 100.0
|
81.8 Percentage
Interval 56.6 to 100.0
|
81.8 Percentage
Interval 58.6 to 100.0
|
|
Segment Level Sensitivity and Specificity of VE-MRI by Dosing Within Platforms and Independent Readers
Siemens - Reader 3: Specificity
|
61.4 Percentage
Interval 41.6 to 81.1
|
70.5 Percentage
Interval 51.2 to 89.7
|
51.3 Percentage
Interval 35.4 to 67.2
|
SECONDARY outcome
Timeframe: 3 weeksThe 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.
Outcome measures
| Measure |
Cohort 1
n=39 Participants
Dose 1 versus non-contrast MRA
1.0 mg/kg IV ferumoxytol versus non-contrast MRA
|
Cohort 2
n=39 Participants
Dose 2 versus non-contrast MRA
2.5 mg/kg IV ferumoxytol versus non-contrast MRA
|
Cohort 3
n=37 Participants
Dose 3 versus non-contrast MRA
4.0 mg/kg IV ferumoxytol versus non-contrast MRA
|
|---|---|---|---|
|
Segment-level Negative Percent Agreements VE-MRI and Noncontrast MRA
Reader 1: Negative Agreement
|
25.4 Percentage
|
15.9 Percentage
|
13.6 Percentage
|
|
Segment-level Negative Percent Agreements VE-MRI and Noncontrast MRA
Reader 2: Negative Agreement
|
9.9 Percentage
|
13.0 Percentage
|
22.7 Percentage
|
|
Segment-level Negative Percent Agreements VE-MRI and Noncontrast MRA
Reader 3: Negative Agreement
|
5.6 Percentage
|
10.1 Percentage
|
6.1 Percentage
|
SECONDARY outcome
Timeframe: 3 weeksThe 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.
Outcome measures
| Measure |
Cohort 1
n=39 Participants
Dose 1 versus non-contrast MRA
1.0 mg/kg IV ferumoxytol versus non-contrast MRA
|
Cohort 2
n=39 Participants
Dose 2 versus non-contrast MRA
2.5 mg/kg IV ferumoxytol versus non-contrast MRA
|
Cohort 3
n=37 Participants
Dose 3 versus non-contrast MRA
4.0 mg/kg IV ferumoxytol versus non-contrast MRA
|
|---|---|---|---|
|
Segment-level Total Percent, Kappa Statistics Between VE-MRI and Noncontrast MRA
Reader 1: Kappa Statistic
|
0.440 Kappa
|
0.216 Kappa
|
0.182 Kappa
|
|
Segment-level Total Percent, Kappa Statistics Between VE-MRI and Noncontrast MRA
Reader 2: Kappa Statistic
|
0.027 Kappa
|
0.256 Kappa
|
0.401 Kappa
|
|
Segment-level Total Percent, Kappa Statistics Between VE-MRI and Noncontrast MRA
Reader 3: Kappa Statistic
|
0.225 Kappa
|
0.472 Kappa
|
0.108 Kappa
|
Adverse Events
Cohort 1
Serious events: 5 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=40 participants at risk
Dose 1 versus non-contrast MRA
ferumoxytol: Dose 1 versus non-contrast MRA
|
Cohort 2
n=39 participants at risk
Dose 2 versus non-contrast MRA
ferumoxytol: Dose 2 versus non-contrast MRA
|
Cohort 3
n=40 participants at risk
Dose 3 versus non-contrast MRA
ferumoxytol: Dose 3 versus non-contrast MRA
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
5.0%
2/40 • Number of events 2 • 3 weeks
|
0.00%
0/39 • 3 weeks
|
0.00%
0/40 • 3 weeks
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/40 • 3 weeks
|
0.00%
0/39 • 3 weeks
|
2.5%
1/40 • Number of events 1 • 3 weeks
|
|
Cardiac disorders
Cardiac Failure Congestive
|
2.5%
1/40 • Number of events 1 • 3 weeks
|
0.00%
0/39 • 3 weeks
|
0.00%
0/40 • 3 weeks
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/40 • 3 weeks
|
2.6%
1/39 • Number of events 1 • 3 weeks
|
2.5%
1/40 • Number of events 1 • 3 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/40 • 3 weeks
|
2.6%
1/39 • Number of events 1 • 3 weeks
|
2.5%
1/40 • Number of events 1 • 3 weeks
|
|
Infections and infestations
Osteomyelitis
|
2.5%
1/40 • Number of events 1 • 3 weeks
|
0.00%
0/39 • 3 weeks
|
0.00%
0/40 • 3 weeks
|
|
Vascular disorders
Femoral Artery Occlusion
|
2.5%
1/40 • Number of events 1 • 3 weeks
|
0.00%
0/39 • 3 weeks
|
0.00%
0/40 • 3 weeks
|
|
Vascular disorders
Intermittent Claudication
|
0.00%
0/40 • 3 weeks
|
0.00%
0/39 • 3 weeks
|
2.5%
1/40 • Number of events 1 • 3 weeks
|
Other adverse events
| Measure |
Cohort 1
n=40 participants at risk
Dose 1 versus non-contrast MRA
ferumoxytol: Dose 1 versus non-contrast MRA
|
Cohort 2
n=39 participants at risk
Dose 2 versus non-contrast MRA
ferumoxytol: Dose 2 versus non-contrast MRA
|
Cohort 3
n=40 participants at risk
Dose 3 versus non-contrast MRA
ferumoxytol: Dose 3 versus non-contrast MRA
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
5.0%
2/40 • Number of events 2 • 3 weeks
|
0.00%
0/39 • 3 weeks
|
0.00%
0/40 • 3 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place