- Category: ICUS Weekly News Monitors
1. URO Today , Oct 22, 2016, Ultrasound-contrast-agent dispersion and velocity imaging for prostate cancer localization. Authors: Ruud Jg van Sloun, et al
2. DotMed, HealthCareBusiness Daily News, Oct 7, 2016, GE ultrasound contrast agent Optison gets FDA OK for label change by Thomas Dworetzky
Oct 22, 2016
Ultrasound-contrast-agent dispersion and velocity imaging for prostate cancer localization.
Ruud Jg van Sloun, Libertario Demi, Arnoud W Postema, Jean Jmch de la Rosette, Hessel Wijkstra, Massimo Mischi
Prostate cancer (PCa) is the second-leading cause of cancer death in men; however, reliable tools for detection and localization are still lacking. Dynamic Contrast Enhanced UltraSound (DCE-US) is a diagnostic tool that is suitable for analysis of vascularization, by imaging an intravenously injected microbubble bolus. The localization of angiogenic vascularization associated with the development of tumors is of particular interest. Recently, methods for the analysis of the bolus convective dispersion process have shown promise to localize angiogenesis. However, independent estimation of dispersion was not possible due to the ambiguity between convection and dispersion. Therefore, in this study we propose a new method that considers the vascular network as a dynamic linear system, whose impulse response can be locally identified. To this end, model-based parameter estimation is employed, that permits extraction of the apparent dispersion coefficient (D), velocity (v), and Péclet number (Pe) of the system. Clinical evaluation using data recorded from 25 patients shows that the proposed method can be applied effectively to DCE-US, and is able to locally characterize the hemodynamics, yielding promising results (receiver-operating-characteristic curve area of 0.84) for prostate cancer localization.
Medical image analysis. 2016 Oct 01 [Epub ahead of print]
HealthCareBusiness Daily News
Oct 7, 2016
GE ultrasound contrast agent Optison gets FDA OK for label change
by Thomas Dworetzky , Contributing Reporter
The FDA has approved a label change that allows GE Healthcare's Optison ultrasound contrast agent to be used in a larger range of cases. Specifically, it downgrades its use in patients with cardiac shunts and for administration by intra-arterial injection from a contraindication to a warning and precaution.
Prior to this labeling shift, to use the agent, perflutren protein-Type A microspheres injectable suspension, in suspected cardiac shunt populations, an agitated saline procedure was needed first.
The change makes Optison the first contrast agent for use in the U.S. to be so labelled, GE said in a statement.
The change has brought positive responses from a number of health care professionals, including Dr. Sharon L. Mulvagh, who is professor of medicine, director of the Women's Heart Clinic and preventive cardiology consultant in cardiovascular diseases at the Mayo Clinic and Mayo Clinic College of Medicine, GE noted.
“This label change will allow more patients access to a diagnostic imaging tool that has established safety and efficacy. The FDA’s decision to remove this contraindication is supported by a body of data from studies demonstrating safety and clinical benefits of all ultrasound contrast agents in patients with cardiovascular diseases,” said Mulvagh.
Mulvagh called the label change “an important step forward in eliminating barriers to ultrasound contrast use and delivering quality diagnostic care of value to our patients.”
Cardiac shunts are quite common and pose a challenge to clinicians. “Up to one-third of our patients have known or suspected cardiac shunts and, thanks to this important FDA decision, they, too, will now have access to ultrasound contrast agents, which offer an inexpensive and radiation-free option for diagnostic imaging,” noted Dr. Steven Feinstein, co-president of the International Contrast Ultrasound Society.
The decision came about thanks to “the overwhelming weight of evidence from clinical trials," noted Dr. Jonathan Lindner, M. Lowell Edwards Professor of Cardiology at the Knight Cardiovascular Center, Oregon Health & Science University.
He added that “most practitioners in the field of echocardiography already realize the benefits of using contrast agents and understand their capacity to improve diagnostic accuracy, improve outcomes, and streamline care. However, a major obstacle to widespread use has been lack of consensus and confusion regarding how far one needs to go to exclude shunts, no matter how small.”
The clinical advantage of appropriate use of the contrast agent was highlighted by the Head of Global Medical Services at GE Healthcare, Mark Hibberd, who added that Optison use will expand the imaging options and facilitate the care of “the clinically important group of patients who have suboptimal echocardiograms, and a need for left ventricular opacification and delineation of LV borders.”
The contrast market is set to surpass $6 billion by 2022, according to GlobalData research announced in April. The market was “just over $4.3 billion in 2015,” giving a compound annual growth rate of 4.9 percent.