1. Healio, Apr 5, 2016, FDA approves Lumason for hepatic lesions in adults, children
2. DOTmed.com, April 04, 2016, FDA clears LUMASON, Bracco contrast agent, for liver ultrasound By Gus Iversen
3. AuntMinnie.com, Mar 30, 2016, Ultrasound Insider By Erik Ridley
Apr 5, 2016
FDA approves Lumason for hepatic lesions in adults, children
The FDA has approved Lumason for use in ultrasonography of the liver to differentiate between hepatic lesions in adult and pediatric patients, according to a press release from the manufacturer.
Lumason (sulfur hexafluoride lipid-type A microspheres, Bracco Diagnostics), a contrast agent comprised of gas-filled microspheres that reflect sound waves to enhance an image, will improve the sensitivity and specificity of ultrasonography to better differentiate between malignant and benign focal hepatic lesions. It is the first approved ultrasound contrast agent for children, according to the release.
“Bracco is delighted to obtain FDA approval for the use of Lumason in liver imaging for both adult and pediatric patients,” Fulvio Renoldi Bracco, head of global business unit imaging at
Bracco Imaging, said in the release. “The use of contrast-enhanced ultrasound for characterization of focal liver lesions is already established in several countries in Europe and Asia, and Bracco is glad to offer this diagnostic option to U.S. patients.”
The FDA first approved Lumason in 2014 for use in echocardiograms of patients whose ultrasound image of the heart were too difficult to see with ultrasound waves.
Lumason should only be used for ultrasonography of the liver for liver lesions and in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with suboptimal echocardiograms, according to the release.
Contraindications for use mentioned in the release include: known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts, and history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients.
April 04, 2016
FDA clears LUMASON, Bracco contrast agent, for liver ultrasound
by Gus Iversen , DOTmed News Online Editor
Bracco announced today that the FDA has given clearance to the contrast agent LUMASON for use in liver ultrasound for characterization of focal liver lesions. The agent — known globally as SonoVue — is also now the first ultrasound contrast agent approved in the U.S. for use in pediatric patients.
"The use of contrast-enhanced ultrasound for characterization of focal liver lesions is already established in several countries in Europe and Asia, and Bracco is glad to offer this diagnostic option to U.S. patients," said Fulvio Renoldi Bracco, Head of Global Business Unit Imaging at Bracco Imaging, in a statement.
LUMASON had already been cleared 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 in adult patients. That approval took place in October 2014.
The agent has been marketed for over 14 years in more than 40 countries. It is made up of gas-filled microspheres that reflect sound waves to enhance ultrasound images.
"The expanded indication for LUMASON now offers health care professionals and their patients further benefits of our ultrasound contrast agent," said Vittorio Puppo, CEO and president of Bracco Diagnostics, in the release. "This approval demonstrates Bracco's leadership and commitment to the imaging community, across imaging modality and service lines. We are proud to be a leader in contrast imaging and delivery systems, and of our continuous investment in imaging activities to help improve patient care in the U.S."
Mar 30, 2016
By Erik Ridley
Contrast-enhanced ultrasound (CEUS) is employed routinely -- and to substantial clinical benefit -- around the world for radiology applications. However, in the U.S., regulatory clearance has remained limited to cardiology indications.
The seemingly interminable delay has long stuck in the craw of ultrasound contrast experts, many of whom now advocate that this valuable problem-solving tool be used off-label in the U.S. There's never been a better time: CEUS seems well-positioned to benefit from growing questions over radiation exposure and the risk of contrast-induced nephrotoxicity from contrast-enhanced CT, as well as concerns about the safety of gadolinium-based MR contrast agents.
In a presentation at the American Institute of Ultrasound in Medicine (AIUM) annual meeting in New York City, Dr. Michelle Robbin from the University of Alabama at Birmingham shared some tips for integrating CEUS into your practice now. Our coverage of her presentation is this newsletter's Insider Exclusive, which you have access to before our regular members.
Speaking of CEUS, another presentation at AIUM 2016 reported that the combination of contrast-enhanced transrectal ultrasound-guided biopsy and medially directed sextant biopsy was the best biopsy approach for the vital task of detecting high-grade prostate cancers.
Also at AIUM 2016, researchers shared how a focused cardiac ultrasound exam yielded a faster and more accurate diagnosis for thoracic aortic dissection, also known as the "Great Masquerader."
Meanwhile, Dr. Stamatia Destounis of Elizabeth Wende Breast Care in Rochester, NY, reported that ultrasound screening in women with dense breasts can identify invasive cancers not seen on mammography, and that performance improves with experience. What else did the outpatient breast center learn during its second year of providing breast ultrasound screening for women with dense breasts?
If widely adopted, prenatal ultrasound could significantly affect half of maternal deaths in the developing world, according to Dr. Alfred Abuhamad of Eastern Virginia Medical School. Click here for our coverage of the plenary session at AIUM 2016.
In big industry news this month, Canon completed a $5.9 billion acquisition of Toshiba Medical Systems. Click here to get all of the details in our report by Editor-in-Chief Brian Casey.
Also, a quantitative ultrasound computer-aided detection algorithm is showing promise for diagnosing several diseases at once. International Editor Eric Barnes has our coverage.
Finally, Italian researchers found that CEUS is useful for characterizing small renal masses that are indeterminate on contrast-enhanced CT or MRI.
Physician Group Applauds FDA Approval of New Liver Imaging Agent in the US
Apr 4, 2016
Physician Group Applauds FDA Approval of New Liver Imaging Agent in the US
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.
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
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.).
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.
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 &
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
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.
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.
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.
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.
* Felix Arlt