TY - JOUR
T1 - Evaluation of neck and body metastases to nodes with ferumoxtran 10-enhanced MR imaging
T2 - Phase III safety and efficacy study
AU - Anzai, Yoshimi
AU - Piccoli, Catherine W.
AU - Outwater, Eric K.
AU - Stanford, William
AU - Bluemke, David A.
AU - Nurenberg, Pamela
AU - Saini, Sanjay
AU - Maravilla, Kenneth R.
AU - Feldman, David E.
AU - Schmiedl, Udo P.
AU - Brunberg, James A.
AU - Francis, Isaac R.
AU - Harms, Steven E.
AU - Som, Peter M.
AU - Tempany, Clare M.
PY - 2003/9/1
Y1 - 2003/9/1
N2 - PURPOSE: To determine the safety and efficacy of ferumoxtran 10-enhanced magnetic resonance (MR) imaging for diagnosis of metastases to lymph nodes and the clinical usefulness of ferumoxtran 10 in nodal staging. MATERIALS AND METHODS: One hundred fifty-two patients were injected with ferumoxtran 10. Readers independently evaluated precontrast MR images by using node size criteria and subjective assessment of other imaging features. Ferumoxtran 10-enhanced MR images were evaluated alone and paired with precontrast images for comparison. The diagnostic performances of precontrast MR size criteria and postcontrast MR imaging were evaluated with receiver operating characteristic (ROC) analysis. Lymph node signal intensity was correlated with histopathologic findings. MR imaging and histopathologic nodal stages were compared. RESULTS: Node-level sensitivity, specificity, and accuracy of precontrast MR imaging were 54%, 82%, and 68%, respectively, with node size criterion alone; 91%, 51%, and 71%, respectively, with subjective reader assessment; 85%, 85%, and 85%, respectively, with postcontrast MR imaging alone; and 83%, 77%, and 80%, respectively, with paired pre- and postcontrast MR imaging. Compared with size criteria, subjective reader assessment had higher sensitivity but substantially lower specificity. Areas under the ROC curve for pre- and postcontrast MR imaging were 0.76 and 0.83, respectively. Nonmetastatic nodes had significantly lower signal intensity than metastatic nodes on postcontrast T2-weighted MR images (P < .001). Postcontrast nodal staging was significantly more accurate than precontrast nodal staging (P < .01). Headache, back pain, vasodilatation, and urticaria each occurred in 6% of patients. CONCLUSION: Ferumoxtran 10-enhanced MR imaging was safe and effective and facilitated improved diagnostic performance. Use of iron oxide-enhanced MR imaging increased the positive predictive value by 20% and the accuracy by 14% compared with reader assessment. Differentiating patients with no nodal metastatic involvement was more reliable with ferumoxtran 10-enhanced MR imaging than with precontrast MR imaging.
AB - PURPOSE: To determine the safety and efficacy of ferumoxtran 10-enhanced magnetic resonance (MR) imaging for diagnosis of metastases to lymph nodes and the clinical usefulness of ferumoxtran 10 in nodal staging. MATERIALS AND METHODS: One hundred fifty-two patients were injected with ferumoxtran 10. Readers independently evaluated precontrast MR images by using node size criteria and subjective assessment of other imaging features. Ferumoxtran 10-enhanced MR images were evaluated alone and paired with precontrast images for comparison. The diagnostic performances of precontrast MR size criteria and postcontrast MR imaging were evaluated with receiver operating characteristic (ROC) analysis. Lymph node signal intensity was correlated with histopathologic findings. MR imaging and histopathologic nodal stages were compared. RESULTS: Node-level sensitivity, specificity, and accuracy of precontrast MR imaging were 54%, 82%, and 68%, respectively, with node size criterion alone; 91%, 51%, and 71%, respectively, with subjective reader assessment; 85%, 85%, and 85%, respectively, with postcontrast MR imaging alone; and 83%, 77%, and 80%, respectively, with paired pre- and postcontrast MR imaging. Compared with size criteria, subjective reader assessment had higher sensitivity but substantially lower specificity. Areas under the ROC curve for pre- and postcontrast MR imaging were 0.76 and 0.83, respectively. Nonmetastatic nodes had significantly lower signal intensity than metastatic nodes on postcontrast T2-weighted MR images (P < .001). Postcontrast nodal staging was significantly more accurate than precontrast nodal staging (P < .01). Headache, back pain, vasodilatation, and urticaria each occurred in 6% of patients. CONCLUSION: Ferumoxtran 10-enhanced MR imaging was safe and effective and facilitated improved diagnostic performance. Use of iron oxide-enhanced MR imaging increased the positive predictive value by 20% and the accuracy by 14% compared with reader assessment. Differentiating patients with no nodal metastatic involvement was more reliable with ferumoxtran 10-enhanced MR imaging than with precontrast MR imaging.
KW - Contrast media
KW - Iron
KW - Lymphatic system, MR
KW - Lymphatic system, neoplasms
KW - Magnetic resonance (MR), contrast enhancement
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U2 - 10.1148/radiol.2283020872
DO - 10.1148/radiol.2283020872
M3 - Article
C2 - 12954896
AN - SCOPUS:0042932291
SN - 0033-8419
VL - 228
SP - 777
EP - 788
JO - RADIOLOGY
JF - RADIOLOGY
IS - 3
ER -