The First three-Dimensional Mammogram Approved by FDA

The first three-dimensional mammogram device was approved Friday by the US Food and Drug Administration, in the hopes that the new technology would improve early breast cancer detection.

Currently the only technology on the market produces two-dimensional X-ray images of the breast.

“Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

A pair of studies reviewed by the FDA showed a seven percent improvement in the ability of radiologists to “distinguish between cancerous and non-cancerous cases as compared to viewing 2-D images alone,” the regulatory agency said.

The new device, called the Selenia Dimensions System, is made by the Massachusetts-based company Hologic and functions as an upgrade to its current 2-D FDA approved system.

The new technology “produces three-dimensional images which are intended to reveal the inner architecture of the breast, free from the distortion typically caused by tissue shadowing or density,” the company said in a statement.

“The examination, which includes a 3-D tomosynthesis image in combination with a 2-D image, takes only seconds longer than a conventional 2-D digital mammogram at a total exam dose within current FDA guidelines.”

The FDA said the time it takes to capture the 2-D and 3-D images “approximately doubled the radiation dose the patient received” but that any additional risk was believed to be low.

“There is uncertainty for radiation risk estimates; however, the increase in cancer risk from having both a 2-D and 3-D exam is expected to be less than 1.5 percent compared to the natural cancer incidence, and less than one percent compared to the risk from conventional 2-D mammography,” the FDA said.

The US agency also noted the 3-D approach “improved the accuracy with which radiologists detected cancers, decreasing the number of women recalled for a diagnostic workup.”

The National Cancer Institute recommends that women over 40 get mammograms to screen for breast cancer every one or two years.

Hologic stock rose just over two percent following the FDA approval.

Gene Linked to Major Depression Identified

WASHINGTON – A gene that influences how the brain responds to stress may also play a key role in depression, according to a new study.

Numerous studies have shown that the brain molecule neuropeptide Y (NPY) helps to restore calm after stressful events.

However, a team of University of Michigan-led researchers has found that people whose genes predispose them to produce lower levels of NPY have a more intense negative emotional response to stress and may be more likely to develop a major depressive disorder.

They now hope the research will eventually help with early diagnosis and intervention for depression and other psychiatric illnesses, and could help lead the way toward developing more individualized therapies.

“We’ve identified a biomarker – in this case genetic variation – that is linked with increased risk of major depression,” said the study’s senior author Jon-Kar Zubieta, a professor of psychiatry and radiology and research professor at the Molecular and Behavioral Neurosciences Institute.

“This appears to be another mechanism, independent of previous targets in depression research, such as serotonin, dopamine and norepinephrine,” he added.

The study found that people who produce lower amounts of NPY had measurably stronger brain responses to negative stimuli and psychological responses to physical pain.

They were also over-represented in a population diagnosed with a major depressive disorder.

The researchers used three different approaches, each with a varying number of research subjects ranging from 58 to 152, to study the link between NPY gene expression and emotional processing.

First, they classified subject participants into three categories according to low, medium or high NPY expression.

Using functional magnetic resonance imaging (fMRI), they then observed the brain activity as the subjects viewed different words – some neutral (such as ‘material’) negative (like ‘murderer’), and positive words (like ‘hopeful’).

In response to negative words, subjects in the low NPY group showed strong activation in the prefrontal cortex, which is involved with processing emotion, while subjects with high NPY demonstrated a much smaller response.

In the second trial, researchers looked at how subjects described their emotional state before and after a stress challenge in which saline solution was injected into their jaw muscles, causing moderate pain for about 20 minutes.

Those in the low NPY group were more negative both before and after the pain – meaning they were more emotionally affected while anticipating the pain and while reflecting on their experience immediately afterward.

Finally, the researchers compared the NPY genotypes of subjects with major depressive disorders with control subjects and found that people with low NPY were ‘over-represented’ in the group with depression.

“These are genetic features that can be measured in any person. We hope they can guide us toward assessing an individual’s risk for developing depression and anxiety,” said lead author Brian Mickey, an assistant professor in the Department of Psychiatry at the University of Michigan Medical School.

The findings are published in the Archives of General Psychiatry.

New Imaging Technique Helps Pinpoint Tinnitus in Brain

American doctors believe that it is possible to pinpoint the area of the brain that is activated when a person suffers from tinnitus, a chronic ringing of the head or ears that can be as quiet as a whisper or as loud as a jackhammer.

 The team at Henry Ford Hospital in Detroit used a special scanner to map the locations in the brain. They hope it will allow more targeted therapies to be developed.

“Until now, we had no way of pinpointing the specific location of tinnitus in the brain,” says study co-author Michael D. Seidman, M.D., F.A.C.S., director of the Division of Otologic/Neurotolgic Surgery in the Department of Otolaryngology-Head and Neck Surgery at Henry Ford Hospital.

 This imaging technique, magnetoencephalography (MEG), can determine the site of perception of tinnitus in the brain, which could in turn allow physicians to target the area with electrical or chemical therapies to lessen symptoms.

 The findings have been presented Saturday, Oct. 3 at the American Academy of Otolaryngology-Head and Neck Surgery Foundation Annual Meeting and OTO EXPO.

“Since MEG can detect brain activity occurring at each instant in time, we are able to detect brain activity involved in the network or flow of information across the brain over a 10-minute time interval,” explains co-author Susan M. Bowyer, Ph.D. bioscientific senior researcher, Department of Neurology at Henry Ford Hospital.

 “Using MEG, we can actually see the areas in the brain that are generating the patient’s tinnitus, which allows us to target it and treat it,” the expert added.

 Imaging techniques currently used to study tinnitus in the brain – PET and fMRI – provide a general location but are not successful at determining the specific site in the brain that is generating tinnitus symptoms.

 MEG, by comparison, measures the very small magnetic fields generated by intracellular electrical currents in the neurons of the brain. Only 20 sites in the U.S., including Henry Ford, are equipped with a MEG scanner. MEG is presently used at these sites for pre-surgical brain mapping for patients undergoing surgery for brain tumor removal or Epilepsy treatment.

 “With PET and fMRI, most of the auditory cortex of the brain lights up with activity during imaging. MEG, however, is a much more sophisticated machine and it can identify a specific tone or topic point, so only a small area in the brain lights up. It’s like having the lights on in only the city of Detroit, compared to having the lights on in the entire state of Michigan,” explains Dr. Seidman, director of the Otolaryngology Research Laboratory and co-director of the Tinnitus Center at Henry Ford.

 For the study, Dr. Seidman and his colleagues collected MEG results from 17 patients with tinnitus and 10 patients without tinnitus. MEG data were collected for 10 minutes, and then digitally filtered. Study participants wore ear plugs to eliminate outside sounds, and kept their eyes open and fixated on one point on the ceiling in the room during testing.

 With tinnitus patients who have ringing in one ear (unilateral tinnitus), MEG imaging detected the greatest amount of activity in the auditory cortex on the opposite site of the brain from their perceived tinnitus. For patients with ringing in the head or both ears (bilateral tinnitus), MEG imaging revealed activity in both hemispheres of the brain, with greater activity appearing in the opposite side of the brain of the strongest perception of tinnitus.

 Patients without tinnitus had multiple small active areas in the brain, but no particular areas were found to be highly coherent during the 10-minute MEG scan.

 Ultimately, Dr. Seidman says the study establishes MEG as an effective clinical tool for localizing the probably source of tinnitus in patients’ brains. It also has the potential to assist with the development of future interventional strategies to alleviate tinnitus.

EU Grants Nearly $2.25M For Complementary Medicine Research

MUNICH – A three-year project called CAMbrella will receive nearly 1.5 million euros of European Union funding to establish a research network for the study of complementary medicine. The center for complementary medicine research at “Rechts der Isar,” the university hospital of the Technische Universitaet Muenchen will coordinate the project for the winning applicant group, which includes 16 scientific organizations from 12 European countries.

Patients in Vegetative State Can Learn, say Researchers

BUENOS AIRES – An international team of researchers have found that brains of patients in vegetative and minimally conscious state still appears to have the ability to learn.

The team hopes that the finding will lead to a simple test that will enable practitioners to assess the patient’s consciousness without the need of imaging.

During the study, the researchers from University of Buenos Aires, Argentina, the University of Cambridge, UK and the Institute of Cognitive Neurology, Argentina used the classical Pavlonian conditioning to test the responsiveness of patients in vegetative state.

The researchers played a tone immediately prior to blowing air into a patient’s eye.

After some time training, they found that the patients would start blinking when the tone played but before the air puff to the eye.

However, this was not seen in the control subjects, volunteers who had been under anaesthesia.This test will hopefully become a useful, simple tool to test for consciousness without the need for imaging or instructions,” Nature magazine quoted lead author Dr Tristan Bekinschtein, from the University of Cambridge’s Wolfson Brain Imaging Unit, as saying.

“Additionally, this research suggests that if the patient shows learning, then they are likely to recover to some degree,” Bekinschtein added.

The findings appear in the online edition of Nature Neuroscience.