GE Healthcare Announces Norwegian Medicines Agency Approval of Sonazoid™ (powder and solvent for dispersion for injection) to Detect Liver Lesions
Oslo, Norway -- May 2014 -- GE Healthcare today announced the Norwegian Medicines Agency's (NOMA) approval of SonazoidTM (powder and solvent for dispersion for injection), a contrast agent for use in ultrasound imaging of focal liver lesions. The approval is based on clinical studies which showed that Sonazoid significantly improved the visualization of liver lesions during ultrasonography, and may help clinicians better determine whether or not a tumor is malignant or benign.[i]
"Sonazoid is an important tool to improve the current visualization methods to evaluate patients with liver lesions," said Dr. Knut Brabrand, senior consultant in radiology, Oslo University Hospital, Rikshospitalet. "One important feature of Sonazoid is its longer contrast effect which I believe may improve the detection of liver tumors. Also, the ability to differentiate malignant tumors from benign tumors and primary tumors from metastatic tumors is critical to determine the appropriate treatment to help improve a patient's prognosis."
Clinical Trial Results Supporting NOMA Approval
The primary clinical trial results from Japan supporting approval were published in the American Journal of Roentgenology and showed how the accuracy of Sonazoid-enhanced ultrasound in characterizing focal liver lesions as malignant or benign was significantly greater than the accuracy of both non-contrast ultrasound and dynamic CT.1 Other studies have shown that the efficiency of Sonazoid-enhanced ultrasound in detecting liver lesions was significantly higher than that of non-contrast ultrasound. In particular, Sonazoid-enhanced ultrasound was superior to dynamic CT in detecting metastatic liver lesions measuring 1 cm or smaller, indicating that Sonazoid-enhanced ultrasound may be a sensitive tool for following up colorectal cancer patients after primary treatment.[ii],[iii] Sonazoid-enhanced ultrasound has been shown to be a well-tolerated procedure in more than 2,500 patients.[iv]
"The approval of Sonazoid underscores GE Healthcare's commitment to provide medical imaging solutions that help physicians deliver better care to more people," said Jan Makela, General Manager of Core Imaging. "We expect that Sonazoid will make a significant difference in the way Norwegian liver cancer patients are evaluated and treated."
While the prevalence of primary liver cancer is low in Norway, according the World Cancer Research Fund International, the incidence of colon cancer is among the highest in the world. Norway is ranked 6th in the world for prevalence of colon cancer.[v] Approximately 60 to 70 percent of people with colorectal cancer eventually develop a liver tumor. In fact, the liver is the only site of metastasis in up to 35 percent of patients with metastatic colorectal cancer.[vi]
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[i] Moriyasu F, Itoh K. Efficacy of Perflubutane Microbubble--Enhanced Ultrasound in the Characterization and Detection of Focal Liver Lesions:
Phase 3 Multicenter Clinical Trial. AJR 2009; 193:86--95.
[ii] Kudo et al. 2011.
[iii] Kudo et al. 2010
[iv] Sonazoid Summary of Product Characteristics, March 2014
[v] World Cancer Research Fund International http://www.wcrf.org/cancer_statistics/data_specific_cancers/colorectal_c... (accessed 3/12/14)
[vi] Tomlinson JS, Jamigan WR, DeMatteo RP, et al. J, Actual 10-year survival after resection of colorectal liver metastases defines cure. Journal of Clinical Oncology 2007 25(29): 4575-9. Available at http://www.ncbi.nlm.nih.gov/pubmed/17925551