ICUS Weekly News Monitor 1-13-2017

1.  DOTmed.com HealthCareBusiness,  Jan 12, 2017,  Bracco's LUMASON contrast agent gets FDA approval for use in pediatric ultrasound of the urinary tract for vesicoureteral reflux
 
2.  Yahoo! Finance,  Jan 11, 2017,  The FDA removes the contraindication for use of Bracco Diagnostics Inc.'s LUMASON®
 
3.  ICUS,  (recorded webinar),  Contrast-enhanced Abdominal Ultrasound; What is it? How does it work? What is it good for?       By  Stephanie R. Wilson, MD
 
4.  ICUS,  (recorded webinar),  Contrast-enhanced Cardiac Ultrasound - A Tutorial       By Steven B. Feinstein, MD
 
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DOTmed.com
HealthCareBusiness
Jan 12, 2017
 
Bracco's LUMASON contrast agent gets FDA approval for use in pediatric ultrasound of the urinary tract for vesicoureteral reflux
 
(PRNewswire) -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world's leading companies in the diagnostic imaging business, announced today that its contrast agent LUMASON is the first ultrasound contrast agent to obtain Food and Drug Administration (FDA) approval for use in ultrasonography of the urinary tract (voiding ultrasonography) for the evaluation of suspected or known vesicoureteral reflux (VUR) in pediatric patients.
 
VUR is a urinary tract abnormality in neonates, infants and children characterized by retrograde flow of urine from the bladder into the ureter and toward the kidney and represents a common cause of recurrent urinary tract infections and chronic nephropathy in pediatric patients.1 Voiding cystourethrography and direct radionuclide cystography are the imaging procedures currently used to diagnose VUR in the U.S., and both require exposure to ionizing radiation.1
 
"The approval of LUMASON for voiding ultrasonography answers an unmet medical need for an effective imaging study to detect and follow-up VUR without exposing neonates, infants and young children to the potential harmful effects of ionizing radiation," stated Alberto Spinazzi, MD, Head, Global Medical and Regulatory Affairs, Bracco Group. "This approval reflects the efforts of Bracco to seek and provide new and expanded indications for this class of products working collaboratively with the FDA."
 
LUMASON, known globally as SonoVue®, which has been marketed since 2001 and now in more than 30 countries, was initially approved in October 2014 by the FDA for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. LUMASON then gained FDA approval in March 2016 for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients, and in December 2016, for use for the evaluation of suspected or known vesicoureteral reflux in pediatric patients.
 
With a proven safety profile, LUMASON is an ultrasound contrast agent made up of gas-filled microspheres that reflect the sound waves to enhance the echogenicity of the blood or urine, which results in an improvement in the diagnostic quality of the ultrasound images. The agent is packaged in a convenient three-part portable kit that does not require refrigeration or mechanical agitation. Each kit contains a LUMASON vial containing 25 mg of lipid-type A lyophilized powder and 60.7 mg sulfur hexafluoride headspace, a prefilled syringe containing 5 mL of Sodium Chloride 0.9% Injection, USP (Diluent), and a Mini-Spike.2
 
In late 2015, the Centers for Medicare and Medicaid Services (CMS) granted "pass-through" status for LUMASON reimbursement, under the Hospital Outpatient Prospective Payment System (HOPPS). Contrast material is not separately paid by Medicare for outpatient hospitals under HOPPS unless the product has "pass-through" status. This additional payment is unique to LUMASON due to its new technology status. Effective October 1, 2016, CMS approved the request for coverage and coding for liver and/or abdominal ultrasound with contrast under the HOPPS indicating that Healthcare Common Procedure Coding System (HCPCS) code C9744 can be assigned for these procedures when performed in the hospital outpatient setting
 
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Yahoo! Finance
Jan 11, 2017
 
The FDA removes the contraindication for use of Bracco Diagnostics Inc.'s LUMASON® (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use,
 
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world's leading companies in the diagnostic imaging business, announced today that the U.S. Food and Drug Administration (FDA) has removed the contraindication for use of LUMASON in patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts.
 
In view of a potential safety hazard deriving from the use of LUMASON in this patient population, i.e., some of the intravenously injected microspheres bypassing the filtering by the lung and entering the arterial circulation, a specific warning has been maintained in the approved labeling of the agent (WARNINGS AND PRECAUTIONS section, 5.3: Systemic Embolization). Also, LUMASON must not be administered by intra-arterial injection.
 
"The removal of this contraindication implies that the FDA has determined that the benefits from the diagnostic information that could be obtained through the use of LUMASON in patients with cardiac shunts may outweigh the risk for systemic embolization," stated Alberto Spinazzi, MD, Head, Global Medical and Regulatory Affairs, Bracco Group. "FDA review is critical to ensuring the quality, safety and efficacy of contrast agents like LUMASON, and, in general, of medicinal products."
LUMASON, known globally as SonoVue®, which has been marketed since 2001 and now in more than 30 countries, was initially approved in October 2014 by the FDA for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. LUMASON then gained FDA approval in March 2016 for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients, and in December 2016, for use for the evaluation of suspected or known vesicoureteral reflux in pediatric patients.
 
With a proven safety profile, LUMASON is an ultrasound contrast agent made up of gas-filled microspheres that reflect the sound waves to enhance the echogenicity of the blood or urine, which results in an improvement in the diagnostic quality of the ultrasound images. The agent is packaged in a convenient three-part portable kit that does not require refrigeration or mechanical agitation. Each kit contains a LUMASON vial containing 25 mg of lipid-type A lyophilized powder and 60.7 mg sulfur hexafluoride headspace, a prefilled syringe containing 5 mL of Sodium Chloride 0.9% Injection, USP (Diluent), and a Mini-Spike.1
 
In late 2015, the Centers for Medicare and Medicaid Services (CMS) granted "pass-through" status for LUMASON reimbursement, under the Hospital Outpatient Prospective Payment System (HOPPS). Contrast material is not separately paid by Medicare for outpatient hospitals under HOPPS unless the product has "pass-through" status. This additional payment is unique to LUMASON due to its new technology status. Effective October 1, 2016, CMS approved the request for coverage and coding for liver and/or abdominal ultrasound with contrast under the HOPPS indicating that Healthcare Common Procedure Coding System (HCPCS) code C9744 can be assigned for these procedures when performed in the hospital outpatient setting.n patients with cardiac shunts.
 
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Contrast-enhanced Abdominal Ultrasound
What is it? How does it work? What is it good for?
 
Stephanie R. Wilson, MD, FRCPC
Radiologist, Foothills Medical Centre, Calgary
Clinical Professor of Radiology and Medicine, Division of Gastroenterology, University of Calgary
Co-President, International Contrast Ultrasound Society
 
Free ,on-demand lecture presented as part of ICUS Grand Rounds
Recording of a live webinar presented on June 16, 2016
 
image022A certified, pre-recorded one-hour webinar for radiologists, radiologic technologists, gastroenterologists, nephrologists, urologists, oncologists, and internists.
 
Format: ARCHIVED Webinar
Credit:  1.0 AMA-PRA Category 1
Credit:  1.0 ARRT Category A+
Tuition: none
 
 
 
Course Overview
Contrast-enhanced ultrasound (CEUS) imaging requires administration of a microbubble contrast agent and specialized imaging techniques to show sensitive blood flow and tissue perfusion information. CEUS is a safe and easily performed technique that does not require ionizing radiation and has no risk of nephrotoxicity. Although commonly used in Canada, Europe and Asia, the use of microbubble contrast has been off-label and therefore not widely adopted in the U.S.1 The recent Food and Drug Administration approval of a microbubble agent for characterization of focal liver lesions is expected to bring the use of abdominal CEUS into clinical practice in the U.S.
 
This course covers patient indications for abdominal CEUS; how the contrast medium employs gas-filled microbubbles to improve the visualization of abdominal structures; and the benefits and disadvantages of using abdominal CEUS.
 
To register go to:  http://courses.icpme.us/index?string=&keywords=icus&category=&certificate=&format=&author=&x_submission=get
 
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Contrast-enhanced Cardiac Ultrasound
A Tutorial
 
Steven B. Feinstein, MD, FACC, FESC
Professor of Medicine-Cardiology
Academic Cardiologist, Rush University Medical Center,  Chicago, IL
 
Free, on demand; presented as part of ICUS Grand Rounds


image023A certified one-hour archived webinar for cardiologists, cardiac sonographers, radiologists, and radiologic technologists
 
Format: Archived Webinar
Credit:  1.0 AMA PRA Category 1
Credit:  1.0 ARRT Category A
Tuition: none
 
 
Course Overview
Contrast-enhanced cardiac ultrasound, also called contrast echocardiography, improves the diagnostic applications of non-enhanced echocardiography, including delineation of the left ventricular endocardial borders to better assess ejection fraction and evaluation of blood perfusion and volume.(1) Recent studies have also shown that cardiac echo is also a reliable vehicle for drug delivery for diseases of the cardiovascular system.(2) Contrast echo has a high safety profile compared to contrast enhanced- CT and -MRI and is portable and cost-effective.
 
1. The  Basics. American Society of Echocardiography website. http://contrastzone.com/ Accessed October 17, 2016.
2. Castle J, Feinstein SB. Drug and Gene Delivery using Sonoporation for Cardiovascular Disease. Adv Exp Med Biol. 2016;880:331-338.
 
To register go to:  http://courses.icpme.us/index?string=&keywords=icus&category=&certificate=&format=&author=&x_submission=get

ICUS Weekly News Monitor 1-6-2017

ICUS Weekly News Monitor
 
6 January, 2017 - 9am Eastern
 
1.  American Journal of Roentgenology,  Feb 1, 2017,  Retrospective Analysis of the Safety and Cost Implications of Pediatric Contrast-Enhanced Ultrasound at a Single Center    Authors:  Gibran T. Yusuf, et al
 
2.  News-Medical.net,  Jan 3, 2017,  Micro-Ultrasound in Cancer Research     By Susha Cheriyedath, MSc
 
3.  EFSUMB,  Educational Webinars Related to Ultrasound:  19 Jan  2017, 18:00 CET  --  CEUS LI RADS:  The New Classification of Focal Liver Lesions at Risk for HCC

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American Journal of Roentgenology
DOI:10.2214/AJR.16.16700
Feb 1, 2017
 
Retrospective Analysis of the Safety and Cost Implications of Pediatric Contrast-Enhanced Ultrasound at a Single Center
Authors:  Gibran T. Yusuf1; Maria E. Sellars; Annamaria Deganello; David O. Cosgrove; Paul S. Sidhu
1All authors: Department of Radiology, King’s College
London, King’s College Hospital, Denmark Hill, London
SE5 9RS, UK. Address correspondence to G. T. Yusuf
( This email address is being protected from spambots. You need JavaScript enabled to view it. ).
 
OBJECTIVE. Because of concern over medical ionizing radiation exposure of children,
contrast-enhanced ultrasound (CEUS) has generated interest as an inexpensive, ionizing radiation–free alternative to CT and MRI. CEUS has received approval for pediatric hepatic use
but remains off-label for a range of other applications. The purposes of this study were to retrospectively analyze adverse incidents encountered in pediatric CEUS and to assess the financial benefits of reducing the number of CT and MRI examinations performed.
MATERIALS AND METHODS. All pediatric (patients 18 years and younger) CEUS
examinations performed between January 2008 and December 2015 were reviewed. All immediate
reactions deemed due to contrast examinations were documented in radiology reports.
Electronic patient records were examined for adverse reactions within 24 hours not due
to an underlying pathologic condition. With tariffs from the U.K. National Institute of Clinical
Excellence analysis, CEUS utilization cost ($94) was compared with the CT ($168) and
MRI ($274) costs of the conventional imaging pathway.
RESULTS. The records of 305 pediatric patients (187 boys, 118 girls; age range, 1
month–18 years) undergoing CEUS were reviewed. Most of the studies were for characterizing
liver lesions (147/305 [48.2%]) and trauma (113/305 [37.1%]); the others were for renal,
vascular, and intracavitary assessment (45/305 [14.8%]). No immediate adverse reactions occurred.
Delayed adverse reactions occurred in two patients (2/305 [0.7%]). These reactions
were transient hypertension and transient tachycardia. Neither was symptomatic, and both
were deemed not due to the underlying disorder. The potential cost savings of CEUS were $74
per examination over CT and $180 over MRI.
CONCLUSION. Pediatric CEUS is a safe and potentially cost-effective imaging modality.
Using it allows reduction in the ionizing radiation associated with CT and in the gadolinium
 
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News-Medical.net
Jan 3, 2017
 
Micro-Ultrasound in Cancer Research
By Susha Cheriyedath, MSc
 
Cancer angiogenesis is a key focal point in biomedical research. However, lack of a high resolution and portable imaging technique that helps in non-invasive, real-time quantification of various parameters is a huge challenge facing cancer research studies in animals.
 
In cancer research, scientists need to visualize the tumor in real time, to study the effects of drugs on the tumor and aid in further drug discovery. In order to achieve this, they need imaging techniques that help them visualize tumor angiogenesis in a non-invasive manner in real time. Traditional methods including dissection and histology are not of much help in this regard. This is where micro-ultrasound tool is of great use to researchers.
 
Micro-ultrasound uses intravenous contrast agents and very high frequency probes to image tissues in fine detail. It is a promising technique for studying angiogenesis and monitoring therapy. Angiogenesis research is usually performed on mice, as they are easily available in many strains and are also easy to handle. Micro-ultrasound is particularly useful in this application due to the small size of the mice.
 
Why micro-ultrasound?
Several cancer research groups have used micro-ultrasound successfully in angiogenesis visualization. They reported the advantages of using micro-ultrasound as compared to conventional imaging tools such as CT, MRI, SPECT, and PET.
 
These systems have significant drawbacks including complicated operating requirements. None of them provide real-time visualization like micro-ultrasound, which can provide images at 300 frames per second, which helps analyze blood flow and perfusion. A study by Loveless et al showed that micro-ultrasound can be combined with MRI in order to validate results from both the tools.
 
Micro-ultrasound using contrast agents
Contrast agents used in micro-ultrasound improves imaging. These are materials which have optical or acoustic properties that are different from those of the target tissues, and are injected into the bloodstream.
 
Mechanism of drug action
New tools have emerged in the past decade for the targeted treatment of patients with metastatic lung, breast and renal cancer. However, understanding the mechanism of action of these drugs and identifying the category of patients that they benefit the most has been a challenge.
 
Also, there is a lack of biomarkers that can be used to track response to therapy as well as resistance to treatment. Micro-ultrasound is ideal for studying these aspects in preclinical models.
 
Tumor volume and changes
Micro-ultrasound provides a non-invasive way of repeatedly monitoring changes in a tumor over a long period of time. The same animal can be monitored, and acts as its own control. This boosts the accuracy of the study and reduces the number of animals required.
 
Using micro-ultrasound, tumors can be continuously monitored and measured right from initiation of therapy, through different stages of their growth, and during metastases to other organs, tissues and lymph nodes.
 
It has been shown by several studies that the use of micro-ultrasound enables accurate monitoring of tumor size. Images from 3D micro-ultrasound closely correlated with histology images and also precisely confirmed the tumor size and shape in vivo.
 
Other studies reported that 3D micro-ultrasound can not only be used for non-invasive monitoring of tumor volume and growth, but also for evaluating possible chemotherapeutic agents in murine cancer models.
 
Micro-ultrasound systems from Vevo and VisualSonics
A novel micro-ultrasound system developed by VisualSonics seems to be a promising solution to this problem. The revolutionary new technique allows collection of a large amount of data over the entire lifespan of the animals studied, thus reducing the number of animals required. The new system helps rapidly quantify tumor vascularity, 3D tumor volume, and tissue perfusion.
 
Vevo MicroMarker® contrast agents help in visualizing capillaries and monitoring the expression of VEGF and other such endothelial cell markers. Vevo® micro-ultrasound systems are widely used by cancer researchers. Olive et al. used the Vevo high-resolution micro-ultrasound system to create images of normal and diseased tissue in mice as part of a pancreatic cancer study. The researchers also successfully used the Vevo MicroMarker microbubbles to see tumor perfusion.
 
Reviewed by Liji Thomas, MD
 
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EFSUMB Educational Webinars Related to Ultrasound
 
image032
 
CEUS LI RADS: THE NEW CLASSIFICATION OF FOCAL LIVER LESIONS AT RISK FOR HCC
THURSDAY 19 JANUARY 2017, 18:00 CET
 
Register at:  https://attendee.gotowebinar.com/register/8567719338414309380
 
This webinar will be offered free of charge.
Participation at the webinar is limited to a maximum of 100 participants. Online registration will be closed upon reaching the maximum numbers of participants.
Early registration is recommended!
 
Event speakers:
Moderator: Yuko KONO, Department of Medicine, University of San Diego, USA
18:00 Yuko Kono Welcome address. ACR plans illustration. Webinar information.
18:05 Fabio Piscaglia. Rationale and role of the CEUS LI RADS project in the international guidelines arena in 2017.
18:30 Stephanie Wilson Definition and illustrations of the CEUS LI RADS classes.

EFSUMB WEBINAR events are made possible through the generous support of Bracco  

ICUS Weekly News Monitor 12-22-2016

1.  Health Imaging,  Dec 19, 2016,  Contrast-enhanced sonography a ‘sound’ alternative in pediatric advanced imaging     By Dave Pearson
 
2.  Clinical Hemorheology and Microcirculation,  Dec 8, 2016
Percutaneous irreversible electroporation (IRE) of prostate cancer: Contrast-enhanced ultrasound (CEUS) findings during follow up    Authors: Beyer LP, et al

Health Imaging
Dec 19, 2016
 
Contrast-enhanced sonography a ‘sound’ alternative in pediatric advanced imaging
By Dave Pearson
 
Off-label use of contrast-enhanced ultrasound (CEUS) may be the best advanced-imaging choice—safe, accurate and cost-effective as compared to guideline-recommended CT and MRI—for examining children in many instances, according to a British study published online Dec. 13 in the American Journal of Roentgenology.
 
Gibran Yusuf, MBBS, and colleagues at King’s College Hospital in London concluded as much after reviewing the medical records of all pediatric patients who were imaged with CEUS at their institution between January 2008 and December 2015.
 
In total, they looked at 305 cases (187 boys, 118 girls; age range, 1 month to 18 years).
 
Most of the exams were for characterizing liver lesions (48.2 percent) and trauma (37.1 percent); the others were for renal, vascular and intracavitary assessment (14.8 percent).
 
None of the patients had immediate adverse reactions, the authors report.
 
Only two (0.7 percent) had delayed adverse reactions (0.7 percent), and both were asymptomatic and transient (hypertension and tachycardia).
 
The potential cost savings of CEUS were $74 per exam over CT and $180 over MRI, the authors calculate.
 
In their discussion, Yusuf et al. note that, in adults, CEUS has sensitivity and specificity comparable to that of CT and MRI.
 
They point out that CEUS can be safer than CT, as CEUS doesn’t involve ionizing radiation, and safer than MRI, as it almost never requires sedation or anesthesia, much less gadolinium-based contrast administration.
 
CEUS is generally the most cost-effective of the three advanced-imaging modalities—and the authors found the modality saved their institution almost $16,000 versus what the tab would have been had MRI and CT been used where indicated per institutional norms.
 
The authors caution that, while CEUS is safe, the use of any contrast calls for vigilance during and after administration.
 
They also acknowledge the imperfect diagnostic accuracy of CEUS.
 
“Correlating modalities were often performed before the CEUS examination; simultaneous cross-sectional diagnostic imaging was not performed for confirmatory purposes,” they write. “Patients undergoing sonographic examination were referred for further imaging if there was any doubt in the diagnosis, but there remains the possibility of misdiagnosis, as with all methods of imaging.”
 
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Clinical Hemorheology and Microcirculation
vol. Preprint, no. Preprint, pp. 1-6, 2016
PMID: 27935553 DOI: 10.3233/CH-168125
Dec 8, 2016
Percutaneous irreversible electroporation (IRE) of prostate cancer: Contrast-enhanced ultrasound (CEUS) findings during follow up.
 
Authors: Beyer LP1, Pregler B1, Nießen C1, Michalik K1, Haimerl M1, Stroszczynski C1, Jung EM1, Wiggermann P1.
1Department of Radiology, University Medical Center Regensburg, Germany.
 
Abstract
 
PURPOSE:
Irreversible electroporation (IRE) is a focal non-thermal ablation technique that can be used to treat prostate cancer (Pca). The objective was to document the evolution of the volume of the prostate gland and the ablation zone after IRE of Pca.
MATERIAL AND METHODS:
A retrospective analysis of the image findings of CEUS 1 day, 6 weeks, 3 months and 6 months after IRE of 25 patients was conducted. The prostate gland volumes and the size of the ablation zones were documented. Changes in volume and size over time were calculated.
RESULTS:
There was a significant volume reduction of the prostate gland in the first 3 months after ablation. The mean percentage change after 6 weeks was 34.3% with another decrease of 35.0% after 3 months. Volume did not change between month 3 and 6. Size of ablation zone measured in short- and long-axis significantly diminished until 6 months after ablation.
CONCLUSION:
CEUS showed a significant involution of the prostate gland during the first 3 months and a significant decrease of the ablation zone during the first 6 months after IRE of prostate cancer.

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