title: Lymph node metastases from head and neck squamous cell carcinoma: MR imaging with ultrasmall superparamagnetic iron oxide particles (Sinerem MR) -- results of a phase-III multicenter clinical trial.
abstract: The aim of this study was to compare the clinical usefulness of ultrasmall superparamagnetic iron oxide (USPIO) MR contrast media (Sinerem, Guerbet Laboratories, Aulnay-sous-Bois, France) with precontrast MRI in the diagnosis of metastatic lymph nodes in patients with head and neck squamous cell carcinoma, using histology as gold standard. Eighty-one previously untreated patients were enrolled in a multicenter phase-III clinical trial. All patients had a noncontrast MR, a Sinerem MR, and surgery within a period of 15 days. The MR exams were analyzed both on site and by two independent radiologists (centralized readers). Correlation between histology and imaging was done per lymph node groups, and per individual lymph nodes when the short axis was > or = 10 mm. For individual lymph nodes, Sinerem MR showed a high sensitivity (> or = 88%) and specificity (> or = 77%). For lymph node groups, the sensitivity was > or = 59% and specificity > or = 81%. False-positive results were partially due to inflammatory nodes; false-negative results from the presence of undetected micrometastases. Errors of interpretation were also related to motion and/or susceptibility artifacts and problems of zone assignment. Sinerem MR had a negative predictive value (NPV) > or = 90% and a positive predictive value (PPV) > or = 51%. The specificity and PPV of Sinerem MR were better than those of precontrast MR. Precontrast MR showed an unexpectedly high sensitivity and NPV which were not increased with Sinerem MR. The potential contribution of Sinerem MR still remains limited by technical problems regarding motion and susceptibility artifacts and spatial resolution. It is also noteworthy that logistical problems, which could reduce the practical value of Sinerem MR, will be minimized in the future since Sinerem MR alone performed as good as the combination of precontrast and Sinerem MR.
authors.affiliation: Department of Radiology, Institut Gustave Roussy, 39, rue Camille Desmoulins, 94805 Villejuif, France. sigal@igr.fr
authors.forename: R
authors.initials: R
authors.lastname: Sigal
authors.forename: T
authors.initials: T
authors.lastname: Vogl
authors.forename: J
authors.initials: J
authors.lastname: Casselman
authors.forename: G
authors.initials: G
authors.lastname: Moulin
authors.forename: F
authors.initials: F
authors.lastname: Veillon
authors.forename: R
authors.initials: R
authors.lastname: Hermans
authors.forename: F
authors.initials: F
authors.lastname: Dubrulle
authors.forename: J
authors.initials: J
authors.lastname: Viala
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authors.initials: J
authors.lastname: Bosq
authors.forename: M
authors.initials: M
authors.lastname: Mack
authors.forename: M
authors.initials: M
authors.lastname: Depondt
authors.forename: C
authors.initials: C
authors.lastname: Mattelaer
authors.forename: P
authors.initials: P
authors.lastname: Petit
authors.forename: P
authors.initials: P
authors.lastname: Champsaur
authors.forename: S
authors.initials: S
authors.lastname: Riehm
authors.forename: Y
authors.initials: Y
authors.lastname: Dadashitazehozi
authors.forename: T
authors.initials: T
authors.lastname: de Jaegere
authors.forename: G
authors.initials: G
authors.lastname: Marchal
authors.forename: D
authors.initials: D
authors.lastname: Chevalier
authors.forename: L
authors.initials: L
authors.lastname: Lemaitre
authors.forename: C
authors.initials: C
authors.lastname: Kubiak
authors.forename: R
authors.initials: R
authors.lastname: Helmberger
authors.forename: P
authors.initials: P
authors.lastname: Halimi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000000981:diagnostic imaging* / Q000473:pathology*; D003287:Contrast Media; D003911:Dextrans; D005260:Female; D052203:Ferrosoferric Oxide; D006258:Head and Neck Neoplasms / Q000473:pathology*; D006801:Humans; D007501:Iron; D008207:Lymphatic Metastasis / Q000175:diagnosis* / Q000473:pathology / Q000648:ultrastructure; D008279:Magnetic Resonance Imaging / Q000379:methods*; D058185:Magnetite Nanoparticles; D008297:Male; D008875:Middle Aged; D010087:Oxides; D012680:Sensitivity and Specificity; D014463:Ultrasonography
chemical_list: D003287:Contrast Media; D003911:Dextrans; D058185:Magnetite Nanoparticles; D010087:Oxides; C097921:ferumoxtran-10; D007501:Iron; D052203:Ferrosoferric Oxide