ICUS Weekly News Monitor 2-16-2017

  1. Dovepress,  Feb 14, 2017,  Correlations of microvascular blood flow of contrast-enhanced ultrasound and HGF/c-Met signaling pathway with clinicopathological features and prognosis of patients with hepatocellular carcinoma    Authors:      Peng-Hui Zhuang, et al
  2. Mass Device,  Feb 2, 2017,  Lantheus wins FDA nod for Definity imaging agent label update. By Fink Densford
  3. StreetInsider.com,  Feb 2, 2017, Lantheus (LNTH) Announces FDA Approval of DEFINITY Label Update
  4. RSNA Radiology,  Feb 1, 2017,  Integration of Contrast-enhanced US into a Multimodality Approach to Imaging of Nodules in a Cirrhotic Liver: How I Do It. Authors: Patricia C. Jo, MD, et al

Dovepress

DOI https://doi.org/10.2147/OTT.S113353

Volume 2017:10 Pages 847—857

Correlations of microvascular blood flow of contrast-enhanced ultrasound and HGF/c-Met signaling pathway with clinicopathological features and prognosis of patients with hepatocellular carcinoma

Feb 14, 2017

Authors: Peng-Hui Zhuang,1 Lei Xu,1 Lu Gao,2 Wei Lu,3 Li-Tao Ruan,4 Jin Yang1

1Department of Surgery, 2Department of Internal Medicine, The Hospital of Xi’an Jiao Tong University, 3Department of Gastroenterology, Xi’an First Hospital, 4Department of Ultrasound, The First Affiliated Hospital of Xi’an Jiao Tong University, Xi’an, People’s Republic of China

Abstract: The study is designed to explore the correlations of microvascular blood flow of contrast-enhanced ultrasound (CEUS) and hepatocyte growth factor (HGF)/c-Met signaling pathway with clinicopathological features and prognosis of patients with hepatocellular carcinoma (HCC). One hundred and eighteen patients pathologically diagnosed as primary HCC were selected. All HCC patients underwent CEUS examination before operation. HCC tissues and adjacent normal tissue specimens were obtained to detect the protein rates of HGF and c-Met expressions by immunohistochemistry. The mRNA expressions of HGF and c-Met were detected by quantitative real-time polymerase chase reaction assay. The microvessel density (MVD) was tested by CD34 immunohistochemistry. Compared with liver parenchyma, the HCC lesions had higher MVD, preoperative peak intensity (PI), area under the curve (AUC), lower preoperative time to peak (TTP), and washout time (WOT). Compared with adjacent normal tissues, the protein and mRNA expressions of HGF were reduced in HCC tissues, but the protein and mRNA expressions of c-Met and MVD were increased. The protein expressions of HGF and c-Met exhibited evident correlations with TNM stage, tumor size, vascular invasion, liver cirrhosis, and hepatitis B virus and hepatitis C virus infection of HCC patients. The tumor size and number, vascular invasion, the protein expressions of HGF and c-Met, and MVD were associated with the TTP, PI, WOT, and AUC of CEUS in HCC patients. The protein expressions of HGF and c-Met, MVD and preoperative PI revealed negative associations with the prognosis of HCC patients. In conclusion, quantitative parameters of CEUS and HGF/c-Met signaling pathway-related proteins may be helpful for early diagnosis and prognosis prediction of HCC patients.


Mass Device

Lantheus wins FDA nod for Definity imaging agent label update

Feb 2, 2017
By Fink Densford

Lantheus Medical Imaging (NSDQ:LNTH) said today it won FDA approval for a label update on its Definity imaging agent which removed a contraindication related to use in patients with a known or suspected cardiac shunt.

The agent is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and improve the delineation of the left ventricular endocardial border, the North Billerica, Mass.-based company said.

The FDA’s decision to remove the contraindication was based on publications and data supporting the safety of the contrast fluid in patients with cardiac shunts, Lantheus said.

“The echocardiography medical and scientific community has long demonstrated the safety of echocardiographic contrast agents through published clinical studies which has supported the removal of the contraindication for Definity in patients with cardiac shunts. This is particularly noteworthy as Definity is the most widely used echocardiography agent in the U.S. with published data supporting its safety profile across multiple care settings and across gender and race in adults, including those age 65 and older. This is an important step toward broader acceptance and appropriate use of echo contrast agents, which can safely and cost effectively provide critical information to help clinicians accurately diagnose and manage patients to achieve better outcomes,” Dr. Neil Weissman of Washington D.C.’s MedStar Health Research Institute

“The label change implemented by FDA is reflective of both the extensive data on contrast agents and the well characterized and stable safety profile of Definity, which has been used to perform more than seven million echocardiography studies. The removal of the cardiac shunt contraindication is expected to provide patients who could benefit from this important diagnostic tool with greater access to Definity when undergoing cardiac ultrasound imaging,” chief medical officer Cesare Orlandi said in a press release.

Last September, Lantheus priced a $40 million offering with funds slated to pay down approximately $55 million of the outstanding principal balance under its senior secured credit facilities.

In August, Lantheus sold its Australian radiopharmacy servicing business to Global Medical Solutions.


StreetInsider.com

Lantheus (LNTH) Announces FDA Approval of DEFINITY Label Update

Feb 2, 2017

Lantheus Medical Imaging, Inc. (“Lantheus”) today announced U.S. Food and Drug Administration (FDA) approval of an important label update for DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension which removes the contraindication statement related to use in patients with a known or suspected cardiac shunt from the U.S. Prescribing Information. DEFINITY is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

A cardiac shunt is a pattern of blood flow in the heart that deviates from the normal path of the circulatory system, which may present in 10 to 35 percent of patients. These patients were previously excluded from receiving a valuable echo contrast study of the left ventricle. The FDA’s decision to remove the contraindication concerning known or suspected cardiac shunts was based on Lantheus’ submission referencing several publications and data supporting the safety of echocardiography contrast products in patients with cardiac shunts. Information concerning administration in patients with a cardiac shunt appears in the Warnings section of the DEFINITY Prescribing Information.

“The label change implemented by FDA is reflective of both the extensive data on contrast agents and the well characterized and stable safety profile of DEFINITY, which has been used to perform more than seven million echocardiography studies,” said Cesare Orlandi, Chief Medical Officer at Lantheus. “The removal of the cardiac shunt contraindication is expected to provide patients who could benefit from this important diagnostic tool with greater access to DEFINITY when undergoing cardiac ultrasound imaging.”

Neil Weissman, M.D., President of MedStar Health Research Institute (Washington, DC), Professor of Medicine at Georgetown University and Past President of the American Society of Echocardiography commented, “The echocardiography medical and scientific community has long demonstrated the safety of echocardiographic contrast agents through published clinical studies which has supported the removal of the contraindication for DEFINITY in patients with cardiac shunts. This is particularly noteworthy as DEFINITY is the most widely used echocardiography agent in the U.S. with published data supporting its safety profile across multiple care settings and across gender and race in adults, including those age 65 and older.”

Dr. Weissman continued, “This is an important step toward broader acceptance and appropriate use of echo contrast agents, which can safely and cost effectively provide critical information to help clinicians accurately diagnose and manage patients to achieve better outcomes.”


RSNA Radiology

Integration of Contrast-enhanced US into a Multimodality Approach to Imaging of Nodules in a Cirrhotic Liver: How I Do It

Feb 1, 2017
Authors: Patricia C. Jo, MD; Hyun-Jung Jang, MD; Peter N. Burns, PhD; Kelly W. Burak, MD; Tae Kyoung Kim, MD; Stephanie R. Wilson, MD

From the Department of Radiology (P.C.J., S.R.W.) and Department of Medicine, Division of Gastroenterology (K.W.B., S.R.W.), Foothills Medical Centre, University of Calgary, 1403 29 St NW, Calgary, AB, Canada T2N 2T9; Department of Medical Imaging, Toronto General Hospital, University of Toronto, Toronto, Ont, Canada (H.J.J., T.K.K.); and Department of Imaging Research, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ont, Canada (P.N.B.).Address correspondence to S.R.W. (e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it. )

DOI: http://dx.doi.org/10.1148/radiol.2016151732

Accurate characterization of cirrhotic nodules and early diagnosis of hepatocellular carcinoma (HCC) are of vital importance. Currently, computed tomography (CT) and magnetic resonance (MR) imaging are standard modalities for the investigation of new nodules found at surveillance ultrasonography (US). This article describes the successful integration of contrast material–enhanced US into a multimodality approach for diagnosis of HCC and its benefits in this population. The application of contrast-enhanced US immediately following surveillance US allows for prompt dynamic contrast-enhanced evaluation, removing the need for further imaging of benign lesions. Contrast-enhanced US also provides dynamic real-time assessment of tumor vascularity so that contrast enhancement can be identified regardless of its timing or duration, allowing for detection of arterial hypervascularity and portal venous washout. The purely intravascular nature of US contrast agents is valuable as the rapid washout of nonhepatocyte malignancies is highly contributory to their differentiation from HCC. The authors believe contrast-enhanced US provides complementary information to CT and MR imaging in the characterization of nodules in high-risk patients.

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