FDA Advisory Committee Recommends Approval of Bayer's Gadobutrol Injection for MRI of the Central Nervous System

WAYNE, N.J., Jan. 21, 2011 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. announced today that the Peripheral and Central Nervous System Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) voted unanimously that clinical trial and postmarketing data for gadobutrol injection, a macrocyclic 1.0 molar gadolinium-based contrast agent (GBCA), support approval of the product for proposed use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system (CNS).

In addition to the vote for approval, Committee members concurred by a vote of 15 to 1 that gadobutrol should be labeled without an NSF (nephrogenic systemic fibrosis) contraindication in the at-risk population. NSF is a very rare but serious disease that affects a small percentage of patients with severe renal impairment who undergo contrast-enhanced MRI. All marketed GBCAs have a boxed warning about the potential for NSF in patients with chronic severe kidney disease or acute kidney injury.

Gadobutrol is formulated at a 1.0 molar concentration (mol/L) which provides a higher concentration (lower volume) compared to other contrast agents used for CNS imaging. Bayer appreciates the Committee's discussion and suggestions around risk minimization for inadvertent dose misadministration and will continue to work with the FDA as it finalizes its review of gadobutrol.

"Bayer is pleased that the Advisory Committee recognized the totality of the clinical and post-marketing data presented today," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "If approved by the FDA, Bayer believes that gadobutrol will provide healthcare providers with an additional new option for CNS imaging in the United States."

source: PR Newswire


CT scanning aids rapid diagnosis, treatment planning for abdominal pain

The use of CT scanning to evaluate abdominal pain in emergency departments can help physicians arrive at a diagnosis quickly and decisively. A study conducted at Massachusetts General Hospital (MGH) and appearing in the February issue of the American Journal of Roentgenology also finds that information provided by CT scans changed treatment plans for almost half the patients studied and significantly reduced probable hospital admissions.

"Our report addresses an important question with substantial policy relevance – what is the value of CT scanning in the emergency department setting?" says Scott Gazelle, MD, MPH, PhD, an MGH radiologist and director of the Institute for Technology Assessment, senior author of the study. "We specifically looked at how the use of CT for patients with abdominal pain affects physicians' thinking about their patients' diagnosis, their confidence in the diagnosis and the treatment plan; and we found that it significantly affected all three."

Gazelle explains that imaging has become a target for efforts to reduce health care costs. "We've strongly believed that the use of CT in the emergency department can improve efficiency in the workup for many conditions, but we haven't had the evidence we would like to back up that assertion. We chose abdominal pain for our study because it's a common presenting symptom that doesn't have the clearly defined diagnostic guidelines available for other common symptoms that can lead to CT, like headache."

Over a 15-month period from November 2006 through February 2008, physicians in the MGH Emergency Department (ED) who ordered CT scans for patients with abdominal pain not associated with a traumatic injury were asked to complete a questionnaire both before the scan was conducted and again after receiving the results. The questionnaire included the physicians' current diagnosis of the probable cause of symptoms, their level of confidence in the diagnosis and their expected treatment recommendations.

source: EurekAlert


‘Selective Strategy' Recommended for CT Scans in Emergency Department

CINCINNATI―Emergency medicine researchers with the University of Cincinnati (UC) are advocating a new strategy for diagnosing a common but dangerous condition in the emergency room.

Pulmonary embolism, or PE, is a potentially lethal disease in which a blood clot, usually from the legs, travels to the lungs and becomes lodged in a pulmonary artery. But the most common way of testing for PEs, a computed tomography angiography (CTA), comes with so many side effects that researchers in emergency medicine are now looking for ways to reduce use of the test.

In a CTA, a contrast dye is first injected into a vein. As the dye circulates through the body, a CT scan is used to take detailed images of the vessels.

"The use of CTA for blood clots has increased 235 percent between 1991 and 2002,” says Michael Ward, MD, UC emergency medicine operations research fellow. "However, recent literature has shown there are significant risks associated with CTA, including radiation, severe allergic reaction and kidney failure from the contrast dye.

"As more risks are discovered, the development of diagnostic strategies to reduce the use of CTA has become extremely important.”

In a study done June 2010, Ward used existing data to predict costs and results for two models of PE diagnosis. One model tests all patients for PE using a CTA. Another uses compression ultrasound to first test for deep vein thrombosis (DVT), the formation of a blood clot in the leg.

"The diagnosis of a DVT, together with symptoms of PE, almost certainly suggests a PE,” says Ward. "If the test for DVT was positive, the patient was admitted to the hospital for PE and started treatment with anticoagulants. If the test was negative, patients had a CTA performed to evaluate for PE.”

source: University of Cincinnati


Clinical Study Using Revolutions Medical's Proprietary MRI Software Tools Receives Investigational Review Board (IRB) Approval

CHARLESTON, S.C., Jan. 12, 2011 (GLOBE NEWSWIRE) -- Revolutions Medical Corporation ("Revolutions Medical" or the "Company") (OTCBB:RMCP) is happy to report that it has received notice that Investigational Review Board (IRB) approval has been granted this month to the Philadelphia College of Osteopathic Medicine for the research project application titled 'Characterization of Intracranial Hemorrhages by Color MRI Automatic Segmentation,' by Dr. H. Keith Brown and his collaborators. With this new approval, the team of research scientists and clinicians will now begin collecting and analyzing diagnostic images from cases of intracranial hemorrhages using RevColor™, Rev3D™, and RevDisplay™ MRI software. The results of this important clinical study will be presented at scientific sessions throughout the country and submitted for publication in an appropriate medical image analysis related journal later this year.

This study along with the earlier work reported on August 16th 2010 on the 'Characterization of intracranial masses by color MRI automatic segmentation,' will be the basis for new developments targeting the characterization of head trauma injuries and brain tumors. Several important applications may be developed such as the detection and characterizing of sports injuries due to head trauma or concussions.

source: Revolutions Medical Corp.


CT Helps Identify Bullet Trajectories

OAK BROOK, Ill. — Multidetector computed tomography (MDCT) provides an efficient, effective way to analyze wounds from bullets and explosive devices, according to a study published online and in the March issue of Radiology.

"The information provided by MDCT has the potential to improve patient care and aid in both military and civilian forensic investigations," said the study's lead author, Les R. Folio, D.O., M.P.H., from the Uniformed Services University in Bethesda, Md.

U.S. troops stationed in Iraq and Afghanistan face threats from increased sniper activity and the use of improvised explosive devices. Current clinical reports of wounds from bullets and bomb fragments do not include the progression of the trajectory or the direction of the wound path, despite the fact that ballistic injuries are not necessarily confined to a single anatomic structure.

While research has shown the value of CT in the analysis of ballistic wound paths, there is no widely accepted method for consistently and accurately pinpointing wound paths and determining the trajectory angles.

For the study, researchers evaluated the accuracy of MDCT-based ballistic wound path identification. They had a marksman shoot six shots from a rifle into two simulated legs made from various synthetic materials to optimally represent real tissue. The legs were tilted at six different angles based on common sniper heights and distances.

After the leg phantoms were scanned with 64-channel MDCT, several radiologists independently reviewed the CT images and recorded entrance and exit sites for the bullet trajectories. The angles measured on MDCT corresponded closely with those calculated from coordinates with actual shooting angles. Dr. Folio and his team concluded that radiologists could estimate the location of a sniper or an explosive device by extrapolating trajectories identified on MDCT when other factors, such as sniper distance and the victim's position, are known.

source: RSNA


Can Love Last? SBU Imaging Study Attempts to Provide an Answer

An imaging study by the Psychology Department at Stonybrook University in New York attempts to answer the age old question 'can love last'. Using functional MRI study led by Bianca Acevedo, Ph.D., and Arthur Aron, Ph.D. compared neural correlates of the long time mattied and in love with the individuals who had recently fallen in love.

The researchers used fMRI to scan the brains of 10 women and 7 men who were intensely in love after an average 21 years of marriage. Results were compared with an earlier study of individuals who had fallen madly in love within the past year.
They discovered highly similar brain activity in regions associated with reward, motivation and “wanting” in both sets of couples. “We found many very clear similarities between those who were in love long term and those who had just fallen madly in love,” says Dr. Aron, referring to key reward and motivation regions of the brain, largely parts of the dopamine-rich ventral tegmental area (VTA). “In this latest study, the VTA showed greater response to images of a long-term partner when compared with images of a close friend or any of the other facial images.”

Overall, Drs. Acevedo and Aron explain that the brain imaging data on the long-term couples suggest that reward-value associated with a long-term partner may be sustained, similar to new love. Additionally, the results support theories proposing that there might be specific brain mechanisms by which romantic love is sustained in some long-term relationships.


Implantable Ports for Easy Viewing Under CT Scans

St. Paul, MN, January 5, 2011 -- Smiths Medical, a leading global medical devices manufacturer, announced today that they have launched new implantable ports with CT identifiers for easy viewing using X-rays or CT scout scans. The implantable ports facilitate quick acknowledgement that the ports can be used for power injection of contrast media.

The PORT-A-CATH® and P.A.S. PORT® POWER P.A.C. implantable access systems now include an easy-to-see CT identifier on the top of each port. Unlike other ports where the C and T letters are located on the bottom of the portal, and often have to be read backwards under scout scans, PORT-A-CATH® and P.A.S. PORT® POWER P.A.C. systems contain a radiopaque CT identifier that is embedded into the top of the port septum for easy, normal viewing.

Implantable access systems provide a route of delivery for patients requiring long-term medication therapy such as chemotherapy. The portal is implanted under the skin and connected to a catheter that is threaded into a vein. Power injecting may be performed when a patient requires a Contrast Enhanced Computed Tomography (CECT) scan for diagnostic purposes. The power injection procedure requires use of an implantable port, such as the PORT-A-CATH®, PORT-A-CATH® II or P.A.S. PORT® T2 POWER P.A.C. implantable access systems, that can withstand higher pressure and faster flow rates than standard medication infusions.

source: Smiths Medical


Advance makes MRI scans more than seven times faster

BERKELEY — An international team of physicists and neuroscientists has reported a breakthrough in magnetic resonance imaging that allows brain scans more than seven times faster than currently possible.

Series of fMRI brain scans showing new acceleration techniquesfMRI brain scans without the new acceleration techniques (top row) and with increasing numbers of multiplexings and slice accelerations. The bottom row was obtained seven times faster than the top row, although all show similar resolution. Only 4 of the 60 slices of a full, 3-D brain scan are shown. (David Feinberg/UC Berkeley)
In a paper that appeared Dec. 20 in the journal PLoS ONE, a University of California, Berkeley, physicist and colleagues from the University of Minnesota and Oxford University in the United Kingdom describe two improvements that allow full three-dimensional brain scans in less than half a second, instead of the typical 2 to 3 seconds.

"When we made the first images, it was unbelievable how fast we were going," said first author David Feinberg, a physicist and adjunct professor in UC Berkeley's Helen Wills Neuroscience Institute and president of the company Advanced MRI Technologies in Sebastopol, Calif. "It was like stepping out of a prop plane into a jet plane. It was that magnitude of difference."

For neuroscience, in particular, fast scans are critical for capturing the dynamic activity in the brain.

"When a functional MRI study of the brain is performed, about 30 to 60 images covering the entire 3-D brain are repeated hundreds of times like the frames of a movie but, with fMRI, a 3-D movie," Feinberg said. "By multiplexing the image acquisition for higher speed, a higher frame rate is achieved for more information in a shorter period of time."

source: University of California - Berkley


PET scans provide insight into fever-induced epilepsy in children

Reston, Va. (January 3, 2011) — Sudden, catastrophic childhood epilepsy is a parent's worst nightmare, especially in the case of fever-induced refractory epileptic encephalopathy in school-age children (FIRES). While not much is known about the condition, new research published in the January issue of The Journal of Nuclear Medicine shows that positron emission tomography (PET) scans can offer an evaluation of cognitive dysfunction of FIRES, its evolution and further prognosis.

FIRES, a recently named condition, occurs in previously healthy children who, after a brief fever, experience acute seizures that are resistant to medication and last for several weeks. After the seizures stop, children are left with severe cognitive dysfunction, mainly involving language, memory and behavior.

The study, "18F-FDG PET Reveals Frontotemporal Dysfunction in Children with Fever-Induced Refractory Epileptic Encephalopathy," was conducted with eight patients diagnosed with FIRES. The patients were given a neuropsychologic evaluation, a brain MRI and an 18F-FDG PET scan. Severe cognitive dysfunction was noted, and while the MRI tests showed no abnormalities for the patients, the PET scans reported significant cognitive impairment.

Researchers compared the FIRES patients with a pseudo-control group of epilepsy patients with normal MRI and PET scan results. Using statistical parametric mapping, an objective approach to analyzing brain activity, the study exposed that the brain dysfunction was related to the epilepsy in the FIRES patients.

source: EurekAlert