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Research ArticleHEAD AND NECK

Ferumoxtran-10, A Superparamagnetic Iron Oxide as a Magnetic Resonance Enhancement Agent for Imaging Lymph Nodes: A Phase 2 Dose Study

Patricia A Hudgins, Yoshimi Anzai, Marie R Morris and Maria A Lucas
American Journal of Neuroradiology April 2002, 23 (4) 649-656;
Patricia A Hudgins
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Yoshimi Anzai
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Marie R Morris
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Maria A Lucas
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  • Fig 1.
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    Fig 1.

    Mean change in signal intensity over time in the blinded evaluation

    A, With T1-weighted imaging.

    B, With T2-weighted imaging.

    C, With T2*-weighted (FFE-25) imaging.

    D, With T2*-weighted (FFE-80) imaging.

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    Fig 2.

    Axial nonenhanced MR images in a healthy volunteer

    A, Gradient-echo (FFE-80) (120/7.8/1, 80° flip angle) image shows a small left submandibular node (arrow).

    B, On the fast spin-echo T2-weighted (3500/120/1) image, the node (arrow) is difficult to visualize because it is nearly isointense to fat.

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    Fig 3.

    Axial MR images obtained 36 hours after the intravenous administration of 2.6 mg. Fe/kg ferumoxtran-10 in the same volunteer as in Figure 2.

    A, Gradient-echo (FFE-80) (120/7.8/1, 80° flip angle) image shows that the benign node is now homogeneously hypointense (white arrow). Note the multiple additional nodes, some of which are delineated by black arrows, all of which are better visualized now than before contrast enhancement.

    B,T2-weighted (3500/120/1) image obtained at the same level as Figure 1B shows excellent contrast between the enhanced left submandibular node (arrow) and the subcutaneous fat.

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    TABLE 1:

    Specificity in the unblinded evaluation

    Dose Group and Postdose Time PointTotal Lymph NodesSequence Specificity (%)
    T2-WeightedFFE-25FFE-80
    1.1 mg Fe/kg
     6 h41781220
     12 h419056*74*
     24 h418062*87*
     36 h415662*65†
    1.7 mg Fe/kg
     6 h25883244
     12 h25926484
     24 h251007284
     36 h25928476
    2.6 mg Fe/kg
     6 h25925668
     12 h25968496
     24 h2510096100
     36 h251009692
    3.4 mg Fe/kg
     6 h19956389
     12 h1910083‡95
     24 h19898495
     36 h19797979
    • Note.—The specificity was based on the signal intensity and lymph node architecture. A decrease in the signal intensity of a heterogeneous lymph node indicated a false-positive result.

    • * The total number of lymph nodes was 39.

    • † The total number of lymph nodes was 40.

    • ‡ The total number of lymph nodes was 18.

    • View popup
    TABLE 2:

    Specificity in the blinded evaluation

    Dose Group and Postdose Time PointTotal Lymph NodesSequence Specificity (%)
    T2-WeightedFFE-25FFE-80
    1.1 mg Fe/kg
     6 h384516*37
     12 h381140†47
     24 h38295366
     36 h3814*5050
    1.7 mg Fe/kg
     6 h25605252
     12 h25803268
     24 h25884864
     36 h25804864
    2.6 mg Fe/kg
     6 h26884250
     12 h26815854
     24 h26887385
     36 h26888588
    3.4 mg Fe/kg
     6 h20605535
     12 h20707080
     24 h20759595
     36 h207510080
    • Note.— The specificity was based on the signal intensity and lymph node architecture. A decrease in the signal intensity of a heterogeneous lymph node indicated a false-positive result.

    • * The total number of lymph nodes was 37.

    • † The total number of lymph nodes was 35.

    • View popup
    TABLE 3:

    Descriptive statistics for quantitative signal intensity measurements of lymph nodes

    Dose Group and Time PointTotal Lymph NodesQuantitative Signal Intensity Measurements by Sequence*
    T1-WeightedT2-WeightedFFE-25FFE-80
    1.1 mg Fe/kg
     Predose18486.1 + 45.8536.0 + 64.61170.6 + 179.3784.9 + 98.8
     6 h18626.6 + 70.3277.1 + 45.4995.6 + 129.4510.6 + 69.7
     12 h18587.9 + 53.7297.3 + 55.1906.4 + 197.1524.3 + 143.6
     24 h18596.9 + 98.2280.1 + 34.7904.7 + 178.9442.4 + 117.7
     36 h18570.3 + 92.2323.0 + 40.5852.9 + 231.4447.3 + 137.9
    1.7 mg Fe/kg
     Predose18498.5 + 59.0505.5 + 48.6979.7 + 283.4669.5 + 139.8
     6 h15618.7 + 89.1256.1 + 67.0901.3 + 257.9473.8 + 167.6
     12 h18555.2 + 81.3275.8 + 35.4725.7 + 276.5372.5 + 150.3
     24 h18567.9 + 101.0279.9 + 74.6676.7 + 266.4341.7 + 135.5
     36 h18545.0 + 93.0291.5 + 46.6491.3 + 171.6311.7 + 137.6
    2.6 mg Fe/kg
     Predose18470.3 + 55.4561.2 + 71.61150.0 + 125.2777.1 + 95.2
     6 h18568.1 + 80.0293.8 + 54.5754.2 + 148.1493.3 + 116.5
     12 h18534.7 + 109.7225.7 + 50.4535.6 + 93.6328.1 + 64.1
     24 h18511.3 + 85.4196.6 + 42.7335.2 + 85.9243.2 + 66.5
     36 h18494.6 + 119.3209.2 + 41.9316.3 + 79.4188.4 + 48.6
    3.4 mg Fe/kg
     Predose18515.0 + 76.9583.6 + 140.7†1132.2 + 164.7827.2 + 129.3
     6 h18608.3 + 68.8276.8 + 110.9†710.8 + 166.4550.6 + 117.9
     12 h18559.9 + 74.9219.8 + 63.9†452.5 + 125.3346.5 + 72.2
     24 h18513.1 + 68.6178.3 + 58.7†326.2 + 98.4255.4 + 76.9
     36 h18459.4 + 108.4206.8 + 69.8†300.6 + 72.6221.9 + 35.5
     10 d6487.7 + 58.2570.9 + 113.2‡594.1 + 80.6530.8 + 103.8
     1 mo6457.8 + 81.2561.3 + 115.4‡726.9 + 450.8617.3 + 185.4
     3 mo6502.6 + 14.0595.3 + 27.7‡965.2 + 272.3895.8 + 181.5
    • * Data are the mean + the SD.

    • † The total number of lymph nodes was 17.

    • ‡ The total number of lymph nodes was 5.

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American Journal of Neuroradiology: 23 (4)
American Journal of Neuroradiology
Vol. 23, Issue 4
1 Apr 2002
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Patricia A Hudgins, Yoshimi Anzai, Marie R Morris, Maria A Lucas
Ferumoxtran-10, A Superparamagnetic Iron Oxide as a Magnetic Resonance Enhancement Agent for Imaging Lymph Nodes: A Phase 2 Dose Study
American Journal of Neuroradiology Apr 2002, 23 (4) 649-656;

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Ferumoxtran-10, A Superparamagnetic Iron Oxide as a Magnetic Resonance Enhancement Agent for Imaging Lymph Nodes: A Phase 2 Dose Study
Patricia A Hudgins, Yoshimi Anzai, Marie R Morris, Maria A Lucas
American Journal of Neuroradiology Apr 2002, 23 (4) 649-656;
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