ICUS Weekly News Monitor 4-5-2016

Physician Group Applauds FDA Approval of New Liver Imaging Agent in the US
 
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Apr 4, 2016

Physician Group Applauds FDA Approval of New Liver Imaging Agent in the US

Media Release

April 4, 2016

CHICAGO--(BUSINESS WIRE)--The International Contrast Ultrasound Society (ICUS), an international physician group, today commended the U.S. Food and Drug Administration (FDA) on its historic decision to allow the use of Lumason®, an ultrasound contrast agent, for diagnostic imaging of the liver in adults and children. Lumason®, which is sold by Bracco Diagnostics, is the first ultrasound contrast agent to be approved by the FDA for non-cardiac imaging in the US.

ICUS has long advocated for broader acceptance and appropriate use of ultrasound contrast agents, which have strong safety profiles and reduce overall health care costs without exposing patients to ionizing radiation.

Overseas, the use of ultrasound contrast agents is well established for imaging organ systems throughout the body.  However, until now their use in the US has been restricted to cardiac imaging only.  

"The American radiology community has long awaited an approved ultrasound contrast agent for non-cardiac imaging," according to Dr. Edward Grant, an ICUS board member and Chairman of the Department of Radiology at USC Keck School of Medicine.  He said the FDA decision is "a huge step forward" that finally brings state-of-the-art non-invasive ultrasound imaging to patients in the US.

In addition to Lumason®, two other ultrasound contrast agents are FDA-approved in the US for cardiac imaging: Definity® (Lantheus Medical Imaging) and Optison® (GE Healthcare). Outside the US, Lumason® is marketed as SonoVue® and is widely used to for imaging the liver, heart and other organ systems.

All three ultrasound contrast agents are injected into a patient's arm vein during an ultrasound scan.  They are made up of suspensions of gas-filled microspheres that reflect sound waves to enhance the clarity of ultrasound images.    

"Ultrasound contrast agents are safe, low cost, and completely radiation-free imaging tools that can improve the clarity and reliability of front-line ultrasound scans, avoid unnecessary downstream testing, save lives and lower overall health care costs," according to Dr. Steven Feinstein, Co-President of ICUS, who is an expert in cardiac contrast-enhanced ultrasound (CEUS) and professor of medicine at Rush University Medical Center in Chicago.

"This decision will spare many patients, including children, from the cumulative effects of ionizing radiation that are inherent in certain alternative diagnostic imaging options, including SPECT and CT,” according to Dr. Stephanie Wilson, Co-President of ICUS and an expert in radiological CEUS.  She is a Clinical Professor of Radiology and Gastroenterology at the University of Calgary.

The approval also makes Lumason® the first ultrasound contrast agent approved for use in the pediatric population, and will be an especially welcome option for children's medical care. "Children are significantly more sensitive to ionizing radiation than adults," according to Dr. Kassa Darge, an ICUS board member and expert in pediatric CEUS.  Dr. Darge is Chief of the Division of Body Imaging, Department of Radiology at The Children's Hospital of Philadelphia.

Darge was the lead author of a white paper submitted to the FDA in 2013 by ICUS and the Society of Pediatric Radiology.  The paper concluded that there was a "pressing need" to explore effective radiation-free imaging alternatives in pediatric medicine, and that the use of ultrasound contrast agents  in children was "widely accepted throughout Europe and parts of the world other than the United States."

The ICUS Board and imaging professionals had long awaited this significant FDA action that brings the US into line with the rest of the world and gives patients access to the some of the same non-invasive, non-radiation-based diagnostic imaging that has been available around the world for decades.  

ICUS Weekly News Monitor 3-18-2016

1.  Journal of Ultrasound in Medicine,  Mar 1, 2016,  Off-Label Use of Ultrasound Contrast Agents for Intravenous Applications in Children; Analysis of the Existing Literature
Authors: Elsa Rosado, MD and Michael Riccabona, MD
 
2.  Acta Neurochir,  Feb 3, 2016,  CLINICAL ARTICLE - BRAIN TUMORS; Intraoperative 3D contrast-enhanced ultrasound (CEUS): a prospective study of 50 patients with brain tumours
Authors: Felix Arlt, et al
 
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Journal of Ultrasound in Medicine
Published February 2, 2016, doi: 10.7863/ultra.15.02030   JUM March 1, 2016   vol. 35  no. 3  487-496
Mar 1, 2016
 
Off-Label Use of Ultrasound Contrast Agents for Intravenous Applications in Children
Analysis of the Existing Literature
Authors: Elsa Rosado, MD and Michael Riccabona, MD
 
+ Author Affiliations
Department of Radiology, Hospital Prof Doutor Fernando Fonseca, Amadora, Portugal (E.R.); Department of Radiology, Division of Pediatric Radiology, Universitätsklinikum LKH, Graz, Austria (M.R.).
 
Address correspondence to Elsa Rosado, MD, Servico de Radiologia, Hospital Prof Doutor Fernando Fonseca, IC-19, 2720-276 Amadora, Portugal. E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
 
Abstract
 
Objectives—The purpose of this study was to collect and analyze the published data related to intravenous (IV) use of ultrasound (US) contrast agents in children.
 
Methods—We searched the literature to collect all of the published studies reporting the IV administration of a second-generation US contrast agent in children.
 
Results—We analyzed 9 case series and 5 case reports, as well as 5 individual cases, of pediatric contrast-enhanced US use reported in a study group that also included adults. We found that 502 children underwent contrast-enhanced US examinations (mean age, 9.7 years; range, 1 day–18 years). Most patients (89%) were injected with the sulfur hexafluoride contrast agent SonoVue (Bracco SpA, Milan, Italy). The mean dose used was 1.5 mL (range, 0.1–9.6 mL). Only 10 patients (2%) had adverse reactions related to the contrast agent administration: 1 life-threatening anaphylactic shock and 9 mild transitory adverse effects. We additionally found 38 papers in which the study groups included at least 1 child; thus, we obtained a total of 540 reported cases of off-label use of IV US contrast agents in children. The most frequent target organ was the liver, and most indications were related to space-occupying lesion characterization and abdominal evaluations after blunt trauma. Some studies also evaluated the diagnostic performance of contrast-enhanced US in different clinical scenarios and found very good accuracy. Concordance between contrast-enhanced US imaging and the respective reference-standard imaging methods ranged between 83% and 100% in different studies.
 
Conclusions—Our results support the idea that the IV use of US contrast agents in children is safe, feasible, diagnostically robust, and effective.
 
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Acta Neurochir
DOI 10.1007/s00701-016-2738-z
Feb 3, 2016
CLINICAL ARTICLE - BRAIN TUMORS
Intraoperative 3D contrast-enhanced ultrasound (CEUS):
a prospective study of 50 patients with brain tumours
Authors: Felix Arlt 1 & Claire Chalopin2 & Andrea Müns1 & Jürgen Meixensberger1,2 &
Dirk Lindner1
 
1 Klinik und Poliklinik für Neurochirurgie, Universitätsklinik Leipzig,
Liebigstrasse 20, 04103 Leipzig, Germany
2 ICCAS (Innovation Centre Computer Assisted Surgery),
Semmelweisstr 14, 04103 Leipzig, Germany
 
Abstract
Background
Reliable intraoperative resection control during surgery of malignant brain tumours is associated with the longer overall survival of patients. B-mode ultrasound (BUS) is a familiar intraoperative imaging application in neurosurgical procedures and supplies excellent image quality. However, due to resection-induced artefacts, its ability to distinguish between tumour borders, oedema, surrounding tissue and tumour remnants is sometimes limited. In experienced hands, this Bbright rim effect^ could be reduced. However, it should be determined, if contrast-enhanced ultrasound can improve this situation by providing high-quality imaging during the resection. The aim of this clinical study was to examine contrast-enhanced and three-dimensional reconstructed ultrasound (3D CEUS) in brain tumour surgery regarding the uptake of contrast agent pre- and post-tumour resection, imaging quality and in comparison with postoperative magnetic resonance imaging in different tumour entities.
 
Methods
Fifty patients, suffering from various brain tumours intra-axial and extra-axial, who had all undergone surgery with the support of neuronavigation in our neurosurgical department,
were included in the study. Their median age was 56 years (range, 28–79). Ultrasound imaging was performed before the Dura was opened and for resection control at the end of tumour resection as defined by the neurosurgeon. A high-end ultrasound (US) device (Toshiba Aplio XG®) with linear and sector probes for B-mode and CEUS was used. Navigation and 3D reconstruction were performed with a LOCALITE SonoNavigator® and the images were transferred digitally (DVI) to the navigation system. The contrast agent consists of echoic micro-bubbles showing tumour vascularisation. The ultrasound images were compared with the corresponding postoperative MR data in order to determine the accuracy and imaging quality of the tumours and tumour remnants after resection.
 
Results
Different types of tumours were investigated. High, dynamic contrast agent uptake was observed in 19 of 21 patients (90 %) suffering from glioblastoma, while in 2 patients uptake was low and insufficient. In 52.4 % of glioblastoma and grade III astrocytoma patients CEUS led to an improved delineation in comparison to BUS and showed a highresolution imaging quality of the tumour margins and tumour boarders. Grade II and grade III astrocytoma (n=6) as well as metastasis (n = 18) also showed high contrast agent uptake, which led in 50 % to an improved imaging quality. In 5 of these 17 patients, intraoperative CEUS for resection control showed tumour remnants, leading to further tumour resection. Patients treated with CEUS showed no increased neurological deficits after tumour resection. No pharmacological sideeffects occurred.
 
Conclusions
Three-dimensional CEUS is a reliable intraoperative imaging modality and could improve imaging quality. Ninety percent of the high-grade gliomas (HGG, glioblastoma and astrocytoma grade III) showed high contrast uptake with an improved imaging quality in more than 50 %. Gross total resection and incomplete resection of glioblastoma were adequately highlighted by 3D CEUS intraoperatively. This study was supported by a DFGgrant (Deutsche Forschungsgemeinschaft).
 
Registered in the EUClinical Trials Register: https://www.clinicaltrialsregister.
eu/ctr-search/search?query=eudract_number:2010-022057-42
* Felix Arlt
This email address is being protected from spambots. You need JavaScript enabled to view it.

ICUS Weekly News Monitor 2-12-2016

1.  Atherosclerosis,  July, 2015,  Therapeutic ultrasound: Increased HDL-Cholesterol following
infusions of acoustic microspheres and apolipoprotein A-I plasmids   
Authors: Jason W. Castle et al.
 
2.  Echo Research and Practice,  Feb 1, 2016,  Echo Research and Practice is now indexed in PubMed!
 
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Atherosclerosis
Atherosclerosis 241 (2015) 92e99
July, 2015
 
Therapeutic ultrasound: Increased HDL-Cholesterol following
infusions of acoustic microspheres and apolipoprotein A-I plasmids
 
Authors: Jason W. Castle a, *, Kevin P. Kent b, Ying Fan a, Kirk D. Wallace a, Cynthia E.L. Davis a,
Jeannette C. Roberts a, Michael E. Marino a, Kai E. Thomenius a, Hae W. Lim b, Eric Coles c,
Michael H. Davidson c, d, Steven B. Feinstein c, e, Anthony DeMaria f
a General Electric Global Research, Niskayuna, NY, USA
b Formerly GE Global Research, Niskayuna, NY, USA
c SonoGene LLC, Glen Ellyn, IL, USA
d University of Chicago, Pritzker School of Medicine, Chicago, IL, USA
e Rush University Medical Center, Chicago, IL, USA
f Sulpizio Cardiovascular Center, University of California, San Diego, CA, USA
 
Abstract
Background: Low levels of HDL-C are an independent cardiovascular risk factor associated with increased premature cardiovascular death. However, HDL-C therapies historically have been limited by issues relating to immunogenicity, hepatotoxicity and scalability, and have been ineffective in clinical trials.
 
Objective: We examined the feasibility of using injectable acoustic microspheres to locally deliver human ApoA-I DNA plasmids in a pre-clinical model and quantify increased production of HDL-C in vivo.
 
Methods: Our novel site-specific gene delivery system was examined in naïve rat model and comprised the following steps: (1) intravenous co-administration of a solution containing acoustically active microspheres (Optison™, GE Healthcare, Princeton, New Jersey) and human ApoA-I plasmids; (2) ultrasound verification of the presence of the microspheres within the liver vasculature; (3) External application of locally-directed acoustic energy, (4) induction of microsphere disruption and in situ sonoporation; (4) ApoA-I plasmid hepatic uptake; (5) transcription and expression of human ApoA-I protein; and (6) elevation of serum HDL-C.
 
Results: Co-administration of ApoA-I plasmids and acoustic microspheres, activated by external ultrasound energy, resulted in transcription and production of human ApoA-I protein and elevated serum HDL-C in rats (up to 61%; p-value < 0.05).
 
Conclusions: HDL-C was increased in rats following ultrasound directed delivery of human ApoA-I plasmids by microsphere sonoporation. The present method provides a novel approach to promote ApoA-I synthesis and nascent HDL-C elevation, potentially permitting the use of a minimally-invasive ultrasound-based, gene delivery system for treating individuals with low HDL-C.
 
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Echo Research and Practice
Feb 1, 2016
 
Echo Research and Practice is now indexed in PubMed!
 
Echo Research and Practice, the open-access journal endorsed  by the International Contrast Ultrasound Society (ICUS), is now indexed in PubMed. In addition, the journal has been selected for indexing in the Web of Science’s Emerging Sources Citation Index.  Authors submitting their work to the journal can expect to receive an initial response in an average of 25 days, and accepted work will be published in 2 months average.  Members of ICUS receive a 10% discount on the article publication charge.  Authors receive suggestions for increasing post-publication impact, the results of which are visible with article-level metrics. To submit your work in Echo Research and Practice go to:  http://www.echorespract.com

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ICUS is the world’s only professional society exclusively devoted to contrast-enhanced ultrasound (CEUS) medical imaging technology.

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