RESUMO
PURPOSE: Gadobutrol is a 1.0 M macrocyclic magnetic resonance imaging (MRI) contrast agent. A study was performed to evaluate the efficacy and safety of gadobutrol-enhanced versus unenhanced imaging for central nervous system (CNS) lesion visualization and detection. MATERIALS AND METHODS: An international, multicenter, open-label, Phase III clinical trial. Patients underwent unenhanced and gadobutrol 1.0 M-enhanced (0.1 mmol/kg BW) MR imaging using a standardized protocol. Unenhanced and combined unenhanced/gadobutrol-enhanced images were scored by three independent, blinded readers for degree of lesion enhancement, border delineation, internal morphology, and total number of lesions detected (primary efficacy variables). Exact match of the MR diagnoses with the final clinical diagnosis, detection of malignant CNS lesions, and confidence in diagnosis were secondary efficacy variables. RESULTS: Of 343 enrolled patients, 321 were evaluated for efficacy. All primary efficacy endpoints were met: superiority was demonstrated for gadobutrol-enhanced versus unenhanced MR images (P < 0.0001 in all cases) for lesion enhancement, border delineation, and internal morphology. Noninferiority was met for mean number of lesions detected. There were improvements in the sensitivity of malignant lesion detection, without a loss in specificity, exact-match diagnostic accuracy, and reader confidence. Treatment-related adverse events were reported in 4.1% (n = 14); all were nonserious. CONCLUSION: Gadobutrol 1.0M is an effective and well-tolerated contrast agent for CNS MRI.
Assuntos
Neoplasias do Sistema Nervoso Central/diagnóstico , Meios de Contraste , Aumento da Imagem/métodos , Imageamento por Ressonância Magnética , Compostos Organometálicos , Argentina , China , Colômbia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Reprodutibilidade dos Testes , República da Coreia , Sensibilidade e Especificidade , Estados UnidosRESUMO
PURPOSE: To report an experience with helical computed tomographic (CT) angiography as the initial procedure to rule out arterial lesions caused by penetrating neck injuries. MATERIALS AND METHODS: During 27 months, 175 patients were referred for helical CT angiography of the neck because of clinical suspicion of arterial injuries. The protocol included a 100-mL bolus of nonionic contrast material injected at 4.5 mL/sec, with 11-second scanning delay, 3-mm collimation, and pitch of 1.3-2.0. CT images were interpreted prospectively by the emergency radiologist, and two radiologists retrospectively interpreted studies with consensus. Outcome was determined with examination of patients and their charts. The sensitivity, specificity, and positive and negative predictive values were calculated. RESULTS: Studies in two patients were considered inadequate for diagnosis; these patients were referred for conventional arteriography and had normal findings. In 27 patients (15.6%), arterial lesions were detected. One patient had two arterial injuries. Lesions demonstrated with helical CT angiography were arterial occlusion (n = 14), pseudoaneurysm (n = 8), pseudoaneurysm and arteriovenous fistulae (n = 4), and partial thrombosis (n = 2). The remaining 146 patients had normal arteries. On the basis of these findings, patients were treated with surgery (n = 21), endovascular intervention (n = 7), and observation alone (n = 146). CONCLUSION: Results indicate that helical CT angiography can be used as the initial method for evaluation in patients with possible arterial injuries of the neck.
Assuntos
Angiografia , Lesões do Pescoço/diagnóstico por imagem , Tomografia Computadorizada por Raios X , Ferimentos Penetrantes/diagnóstico por imagem , Adolescente , Adulto , Idoso , Lesões das Artérias Carótidas/diagnóstico por imagem , Feminino , Humanos , Processamento de Imagem Assistida por Computador , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Prospectivos , Sensibilidade e Especificidade , Artéria Vertebral/diagnóstico por imagem , Artéria Vertebral/lesõesRESUMO
Magnetic resonance imaging (MRI) studies of the caudate nucleus have reported reversal asymmetry and alterations of its size, suggesting a striate cortical disorder related to attention-deficit hyperactivity disorder (ADHD). The objective was to evaluate whether alterations of the asymmetry and size of the caudate nucleus head exist in a sample of well-controlled 7- to 11-year-old Colombian children, with different types of ADHD. Two groups of cases-ADHD of the combined type and ADHD of the inattentive type-and one control group, were selected. Multiple methods for assessing ADHD (rating scales, psychologic.interview, neurologic history and examination, and neuropsychologic evaluation) were used to confirm the diagnoses. Participants with a history of language disorder, learning disabilities, depression, and other major neurologic and psychiatric conditions were excluded. Finally all groups had 15 children, matched by sex (7 male, 8 female), age, socioeconomic status, and grade. Height, weight, head circumference, and encephalic index were statistically controlled. Three T1-weighted volumetric (three-dimensional) MRI slides of the caudate nucleus head were obtained with a 1.5-Tesla Gyroscan apparatus. The control group had a significantly higher Wechsler Full-Scale IQ than the groups with ADHD of the combined type and ADHD of the inattentive type (P < .001). Volumes from the left caudate nucleus head were significantly larger than volumes from the right in all groups (P < .001). There were no group differences when volumes were compared between groups. All of the groups had left caudate nucleus head volumes significantly higher than right, although there were no between-group differences. The results in relation to previous studies are discussed.