• Início
  • Resultados da busca
  • Efficacy of sonazoid (perflubutane) for contrast-enhanced ultrasound in the differentiation of focal breast lesions: phase 3 multicenter clinical trial.

Efficacy of sonazoid (perflubutane) for contrast-enhanced ultrasound in the differentiation of focal breast lesions: phase 3 multicenter clinical trial.

AJR. American journal of roentgenology (2014-03-26)
Yukio Miyamoto, Toshikazu Ito, Etsuo Takada, Kiyoka Omoto, Toshiko Hirai, Fuminori Moriyasu
RESUMO

The objective of our study was to compare the efficacy of contrast-enhanced ultrasound (CEUS) using the ultrasound contrast agent Sonazoid (perflubutane) with unenhanced ultrasound and supplementary contrast-enhanced MRI in the differential diagnosis (benign vs malignant) of focal breast lesions. The safety of Sonazoid was also assessed in this study. A total of 127 patients with focal breast lesions were enrolled in this study at five centers in Japan. Three reviewers who were blinded to the patient characteristics independently assessed the ultrasound images and MR images in a randomized sequence. The accuracy, sensitivity, and specificity of CEUS, unenhanced ultrasound, and supplementary contrast-enhanced MRI for the differential diagnosis were compared using generalized estimating equation analyses. Diagnostic confidence was also assessed. The accuracy of CEUS was significantly higher than that of unenhanced ultrasound (87.2% vs 65.5%, respectively; p < 0.001). In addition, CEUS showed significantly higher specificity, although the improvement in sensitivity was not statistically significant. The accuracy and specificity were significantly higher with CEUS than with contrast-enhanced MRI, but the improvement in sensitivity was not statistically significant. The area under the curve in a receiver operating characteristic analysis was significantly greater with CEUS than with unenhanced ultrasound. The incidence of adverse events was 11.4% and the incidence of adverse drug reactions was 3.3%. All adverse drug reactions were mild. CEUS using Sonazoid was confirmed to be superior to unenhanced ultrasound for the differential diagnosis (benign vs malignant) of focal breast lesions in terms of diagnostic accuracy with no serious adverse reactions.

MATERIAIS
Número do produto
Marca
Descrição do produto

Sigma-Aldrich
Iron, ≥99%, reduced, powder (fine)
Sigma-Aldrich
N-Methyl-D-glucamine, 99.0-100.5% (titration)
Sigma-Aldrich
Iron, powder, −325 mesh, 97%
Sigma-Aldrich
Carbonyl iron, ≥97% Fe basis
Sigma-Aldrich
N-Methyl-D-glucamine, ReagentPlus®, ≥99.0% (T)
Sigma-Aldrich
Iron, puriss. p.a., carbonyl-Iron powder, low in magnesium and manganese compounds, ≥99.5% (RT)
Sigma-Aldrich
Meglumine, meets USP testing specifications
Sigma-Aldrich
Iron, nanopowder, 35-45 nm particle size, 99.5% trace metals basis
Sigma-Aldrich
Iron, granular, 10-40 mesh, >99.99% trace metals basis
Sigma-Aldrich
Iron, chips, 99.98% trace metals basis
Sigma-Aldrich
Iron, foil, thickness 0.1 mm, ≥99.9% trace metals basis
Sigma-Aldrich
Iron, foil, thickness 0.25 mm, ≥99.99% trace metals basis
Sigma-Aldrich
Iron, wire, diam. 1.0 mm, ≥99.9% trace metals basis
Supelco
Meglumine, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
Iron, carbon coated magnetic, nanopowder, 25 nm avg. part. size, 99.5% trace metals basis
Sigma-Aldrich
Iron, wire, diam. 0.5 mm, ≥99.9% trace metals basis
Sigma-Aldrich
Iron, rod, diam. 6.3 mm, 99.98% trace metals basis
Iron, IRMM®, certified reference material, 0.5 mm wire
Iron, foil, 300x300mm, thickness 0.1mm, hard, 99.5%
Iron, foil, 0.2m coil, thickness 0.5mm, coil width 49mm, armco« soft ingot 99.8+%
Iron, wire reel, 1m, diameter 0.025mm, as drawn, 99.99+%
Iron, wire reel, 20m, diameter 0.125mm, hard, 99.5%
Meglumine, European Pharmacopoeia (EP) Reference Standard
Iron, foil, 10mm disks, thickness 0.01mm, 99.85%
Iron, foil, 10mm disks, thickness 0.01mm, 99.99+%
Iron, foil, 10mm disks, thickness 0.020mm, 99.85%
Iron, foil, 10mm disks, thickness 0.025mm, as rolled, 99.99+%
Iron, foil, 10mm disks, thickness 0.025mm, hard, 99.5%
Iron, foil, 10mm disks, thickness 0.038mm, hard, 99.5%
Iron, foil, 10mm disks, thickness 0.05mm, as rolled, 99.99+%

Redes sociais

LinkedIn icon
Twitter icon
Facebook Icon
Instagram Icon

Merck

Pesquisa. Desenvolvimento. Produção.

Somos um fornecedor global líder para o setor de ciências biológicas, com soluções e serviços para pesquisa, desenvolvimento e produção de biotecnologia, além de produção e desenvolvimento de terapias farmacológicas com medicamentos.

© 2021 Merck KGaA, Darmstadt, Alemanha e/ou suas filiais. Todos os direitos reservados.

A reprodução não autorizada de quaisquer materiais deste site é estritamente proibida.