title: Evaluation of neck and body metastases to nodes with ferumoxtran 10-enhanced MR imaging: phase III safety and efficacy study.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Radiology, University of Washington School of Medicine, Box 357115, 1959 NE Pacific St, Seattle, WA 98195-7115, USA. anzai@u.washington.edu
authors.forename: Yoshimi
authors.initials: Y
authors.lastname: Anzai
authors.forename: Catherine W
authors.initials: CW
authors.lastname: Piccoli
authors.forename: Eric K
authors.initials: EK
authors.lastname: Outwater
authors.forename: William
authors.initials: W
authors.lastname: Stanford
authors.forename: David A
authors.initials: DA
authors.lastname: Bluemke
authors.forename: Pamela
authors.initials: P
authors.lastname: Nurenberg
authors.forename: Sanjay
authors.initials: S
authors.lastname: Saini
authors.forename: Kenneth R
authors.initials: KR
authors.lastname: Maravilla
authors.forename: David E
authors.initials: DE
authors.lastname: Feldman
authors.forename: Udo P
authors.initials: UP
authors.lastname: Schmiedl
authors.forename: James A
authors.initials: JA
authors.lastname: Brunberg
authors.forename: Isaac R
authors.initials: IR
authors.lastname: Francis
authors.forename: Steven E
authors.initials: SE
authors.lastname: Harms
authors.forename: Peter M
authors.initials: PM
authors.lastname: Som
authors.forename: Clare M
authors.initials: CM
authors.lastname: Tempany
mesh_terms: D000293:Adolescent; D000328:Adult; D003287:Contrast Media; D003911:Dextrans; D052203:Ferrosoferric Oxide; D006801:Humans; D007501:Iron; D008198:Lymph Nodes / Q000473:pathology; D008207:Lymphatic Metastasis / Q000175:diagnosis*; D008279:Magnetic Resonance Imaging / Q000379:methods*; D058185:Magnetite Nanoparticles; D015337:Multicenter Studies as Topic; D009367:Neoplasm Staging / Q000379:methods; D010087:Oxides; D012372:ROC Curve; D012449:Safety; D012680:Sensitivity and Specificity
chemical_list: D003287:Contrast Media; D003911:Dextrans; D058185:Magnetite Nanoparticles; D010087:Oxides; C097921:ferumoxtran-10; D007501:Iron; D052203:Ferrosoferric Oxide