ICUS Weekly News Monitor 6-29-17

European Medicines Agency

Committee for Medicinal Products for Human Use (CHMP)

Summary of opinion (post authorisation)

22 June 2017

EMA/CHMP/347620/2017

SonoVue (sulphur hexafluoride)

On 22 June 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product SonoVue. The marketing authorisation holder for this medicinal product is Bracco International B.V.

The CHMP adopted a new indication associated with a new route of administration for intravesical use as follows:

“Ultrasonography of excretory urinary tract

SonoVue is indicated for use in ultrasonography of the excretory tract in paediatric patients from newborn to 18 years to detect vesicoureteral reflux. For the limitation in the interpretation of a negative urosonography, see section 4.4 and 5.1.”

For information, the full indications for SonoVue will be as follows:

Intravenous use:

“This medicinal product is for diagnostic use only.

SonoVue is for use with ultrasound imaging to enhance the echogenicity of the blood, or of fluids in the urinary tract which results in an improved signal to noise ratio.

SonoVue should only be used in patients where study without contrast enhancement is inconclusive.

Echocardiography

SonoVue is a transpulmonary echocardiographic contrast agent for use in adult patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation.

Doppler of macrovasculature

SonoVue increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extracranial carotid or peripheral arteries in adult patients by improving the Doppler signal to noise ratio.

SonoVue increases the quality of the Doppler flow image and the duration of clinically-useful signal enhancement in portal vein assessment in adult patients.

Doppler of microvasculature

SonoVue improves display of the vascularity of liver and breast lesions during Doppler sonography in adult patients leading to more specific lesion characterisation.

Intravesical use:

Ultrasonography of excretory urinary tract

SonoVue is indicated for use in ultrasonography of the excretory tract in paediatric patients from newborn to 18 years to detect vesicoureteral reflux. For the limitation in the interpretation of a negative urosonography, see section 4.4 and 5.1.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

 
 
 
 
 
 

Health Imaging

Brain ultrasound during tumor surgery matches pre-op MRI guidance and then some

Jun 05, 2017

By Dave Pearson

Italian researchers have shown how surgeons resecting glioblastomas, the most common and aggressive brain tumors, can use contrast-enhanced ultrasound to guide their view of tumor location, morphologic features, margins and dimensions in real time and for the duration of the entire surgery.

Radiology has published their findings online, ahead of print.

Francesco Prada, MD, of the Carlo Besta Neurological Institute in Milan and colleagues reviewed the cases of 10 patients who had glioblastoma multiforme and underwent tumor resection surgery with fusion guidance, which allowed the team to combine and then compare intraoperative ultrasound imaging against gadolinium-enhanced T1-weighted MR images obtained preoperatively.

The researchers found that, in all cases, the two sets of images were superimposable with correct scaling and a positional discrepancy of less than two millimeters.

In one patient, the imaging did differ meaningfully between the two modalities: The ultrasound showed the full bulk of the tumor while the MRI supplied peripheral contrast enhancement.

The authors conclude that intraoperative contrast-enhanced ultrasound enables surgeons to access, in real time, key tumor information that compares favorably with targeting information from preoperative gadolinium MRI—and therefore “can be used as an intraoperative guidance tool.”

They note that, compared with neuro navigation guided by static pre-op images, the ultrasound technique is “dynamic, economic and repeatable” throughout the surgery.

“Future studies should investigate the role of intraoperative ultrasound in the evaluation of residual tumor, usually a great challenge for neurosurgeons,” Prada et al. write. “The synergistic use of contrast-enhanced ultrasound with navigation systems and other imaging modalities, such as intraoperative MR imaging, fluorescence imaging and optical imaging, might help maximize resection of glioblastoma multiforme, thereby minimizing the risks for our patients.”

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