Archives: 11/2007
Advanced Imaging Technologies, Inc. (AIT) ( Richland, WA) has announced at the Radiological Society of North America (RSNA) that its ARIA ultrasound breast imaging system is now equipped for image-guided biopsy. The device is the winner of 2007 Frost & Sullivan’s Technology Innovation Award for ultrasound devices. In essence, the ARIA imaging system uses the diffractive properties of sound combined with holography (HU) to create highly-detailed, dynamic three-dimensional images of breast tissue. In transmission optical holography an image is obtained using the interference of two coherent acoustic sources, one being the transmitted wave and the other one, a reference wave. The resulting image is a true hologram.
The company believes that its system delivers better sensitivity for detection of masses in women with dense breast tissue. Furthermore, the company claims that ARIA delivers higher spatial and contrast resolution than regular mammography, or a standard ultrasound.
Features, taken from the product page:
Automated image acquisition of volumetric data sets User-friendly interface Real time image review Standardized, multi-planar imaging protocol Cost-effective Workflow efficiencies No special infrastructure requirements Minimal maintenance One day installation for a standard patient examination room Multiple reimbursement opportunities
Product page and videos: ARIA ultrasound breast imaging system …
Press release: Through-Wave Ultrasound: Effective, Economical and Ideal for Breast Imaging, Biopsy …
(hat tip: MTB Europe)
MIT is reporting that the online Nov. 25 issue of the journal Cancer Therapy contains a multi center study showing that microwave energy is a promising method for tumor ablation, and could be used synergistically with chemotherapy for treatment of breast carcinomas. A two channel 915 MHz focused microwave adaptive phased array thermotherapy system, called Microfocus APA-1000 Breast Thermotherapy System, from Celsion Corporation was used in this study. The device is based on technology originally developed at MIT in the 1980s as a tool for missile detection.
MIT explains:
In this study, large tumors treated with a combination of chemotherapy and a focused microwave heat treatment shrunk nearly 50 percent more than tumors treated with chemotherapy alone…
fifteen patients received two microwave heat treatments, known as thermotherapy, along with four rounds of chemotherapy before surgery. The goal was to shrink tumors sufficiently to enable a breast-conserving lumpectomy procedure instead of the expected, and more invasive, mastectomy. Surgeons concluded that fourteen of the tumors shrunk enough for this to be possible.
In 1990, Dr. Alan J. Fenn, a senior staff member at MIT’s Lincoln Laboratory, adapted the thermotherapy treatment from a system that used focused microwaves to detect missiles and block out interfering enemy signals.
“It’s a very simple idea that can be applied to the treatment of many different cancers, including breast cancer,” Fenn said.
The microwaves, delivered by two applicators placed near the breast, kill the cancerous tissue while preserving normal breast tissue by targeting tumor cells that contain high amounts of both water and ions, Fenn explained. When the microwave energy passes through the tumor, the water molecules begin to vibrate and generate heat through friction. This process eventually elevates the cancer cells to a “high fever” of at least 108 degrees Fahrenheit in most cases, killing them.
“The treatment is well tolerated,” said Dr. Mary Beth Tomaselli, medical director at Comprehensive Breast Center in Coral Springs, Fla., and a surgeon who was also a co-investigator in the study. “The patients who have gone through it had minimal side effects and positive results.”
This is the fourth clinical trial of the therapy since 1999. In a Phase-I safety trial using microwave heat alone, researchers found that both small and large breast tumors could be decreased in size between 30 and 60 percent. In a Phase-II dose-escalation trial for small tumors, scientists increased the amount of heat until 100 percent of the tumor cells were killed, prior to the patients’ receiving a lumpectomy.
Next, researchers treated similar early-stage tumors and noticed that after the surgical removal, none of the patients had tumor cells remaining at the edge of the incision. This is important because additional breast surgery and/or radiation therapy are often recommended for patients that have cancer cells close to the edge of the lumpectomy surgical margin.
Of note, Celsion Corporation is actively working on developing its propriety ThermoDox™ chemotherapy agent, a heat activated liposomal encapsulation of doxorubicin, a drug currently in Phase I studies for liver cancer and loco-regionally advanced recurrent breast cancer. The drug used in the trial was anthracycline.
MIT radar technology fights breast cancer …
The study: Study of preoperative focused microwave phased array thermotherapy in combination with neoadjuvant anthracycline-based chemotherapy for large breast carcinomas (.pdf) Cancer Therapy Vol 5, 401-408, 2007
Product page: ThermoDox™ …
Related: Health Blog Interview: CEO, Red Wine in a Pill, Inc. …
National Institute of Biomedical Imaging and Bioengineering (NIBIB), part of the National Institutes of Health, is throwing $8.5 million of our (and your) hard-earned money to establish the UC Davis-Lawrence Livermore National Laboratory Center for Point-Of-Care Technologies to speed the detection of bloodstream infections.
Here’s what the partnership is planning to accomplish:
The grant… will fund the development of two prototype instruments that simultaneously detect five bacterial and fungal pathogens. The grant also funds evaluations of other exploratory diagnostic technologies intended to prepare the nation for future disasters.
“The goal of our center is to improve the accessibility, portability and field robustness of POC instruments for critical-emergency-disaster care in community hospitals, rural areas and disaster response sites,” said Gerald Kost, professor of Pathology and Laboratory Medicine and director of the POCT-CTR at UC Davis Health System.
Events during Hurricane Katrina demonstrated the basic feasibility of POCT, but follow-up laboratory experiments showed that current equipment is not adequate for field use, said Kost, the grant’s principal investigator.
“We need rapid diagnostics and rugged instruments for use in disasters,” Kost said. “Rescues were slowed during Katrina because hospitals were out of commission. Doctors didn’t have adequate tools needed to make fast diagnoses; treatment was delayed. Instruments could not stand the environmental stresses.”
“Research is needed to develop field-worthy, battery-operated devices robust enough to withstand extreme ranges of humidity, temperature and altitude encountered during rescue operations,” Kost said. “Reagents, test strips and quality-control materials must withstand the same harsh conditions, because it is difficult or impractical to transport materials in environmentally controlled containers that are either refrigerated or heated.”
The diagnostic instruments to be developed will be easy to use with minimal training and rugged, so they can be deployed in challenging environments, said LLNL chemist Ben Hindson, who with chemical engineer John Dzenitis, is directing the grant work at the Laboratory…
Under the grant, the LLNL-UC Davis research team will develop two prototype detection instruments — one for hospital settings and one that is field portable…
The LLNL Pathogen Informatics Group, with assistance from UC Davis researchers, will use its capabilities to design unique DNA signatures or assays for use with the new instruments. The five pathogens for which unique identification signatures will be developed under the grant are:Methicillin-resistant Staphylococcus aureus (MRSA)… Pseudomonas aeruginosa … Escherichia coli … Streptococcus pneumoniae … Candida … As envisioned, blood samples would be loaded into the LLNL-UC Davis instruments, which would automatically handle all of the processing steps.
Instead of relying on the polymerase chain reaction (PCR) technique, the instruments will use a new DNA amplification method called loop mediated amplification (LAMP).
The LAMP method uses a portion of the Bacillus stearothermophilus DNA polymerase protein, an enzyme that splits the double strand of DNA and allows it to be copied at a single temperature (63 degrees Celsius or 145 degrees Fahrenheit), rather than using multiple cycles of heating and cooling, as PCR requires.
Initially, using a blood sample from one person, the instruments will run a simultaneous test for all five pathogens within one hour. Eventually, the team hopes to outfit the instruments with the capability to run tests for all five pathogens within an hour for several people at the same time, Hindson said.
Several LLNL-developed biodetection technologies, such as the Autonomous Pathogen Detection System, that are designed to protect against bioterrorism, will provide some of the foundational technologies for these new POC instruments.
Or put more simply, the government is now in the business of developing medical devices. By the way, did you notice any lack of innovation from the private sector? We certainly did not.
Press release: NIH establishes UC Davis-LLNL Center for Point-Of-Care Technologies to speed detection of bloodstream infections …
In the latest study, Emory University investigators discovered that stereoscopic digital mammography, a novel experimental imaging modality, “allows clinicians to detect more lesions and could significantly reduce the number of women who are recalled for additional tests following routine screening mammography.” The findings of the study–a reduction by 49% of false-positive results–were just presented at the annual meeting of the Radiological Society of North America.
Stereoscopic Digital Mammography (SDM) was developed by BBN Technologies from Cambridge, Massachusetts.
Here’s what the company says about its device:
The current standard method to screen for breast cancer is x-ray mammography. In a standard mammographic screening exam, radiologists view the breast in the form of two orthogonal 2D images, which severely limits their ability to derive information about the three-dimensional layout of the breast tissue. Specific limitations in lesion detection with standard mammography include:
A true lesion often remains undetected when masked in the 2D images by overlying or underlying normal tissue, leading to false negative examinations. Overlapping of normal tissue at different depths within the breast, which in the 2D projected image may mimic a true focal lesion, lead to false positive detections. Information regarding the volumetric structure of the breast that can be derived from the pair of 2D images is very limited and often omits information that can be important in detecting suspicious lesions. With BBN’s patented Stereoscopic Digital Radiography system, the radiologist sees the breast in stereo providing a direct, intuitive, in-depth view of the internal structure of the breast. The stereoscopic display workstation developed by BBN consists of a high-resolution grayscale stereo display developed by Planar Systems Inc in collaboration with BBN, and a BBN-developed software application that permits the radiologist to control many aspects of the displayed stereo image.
By providing an in-depth view of the breast, stereo mammography substantially reduces the limitations of standard mammography:Masking of subtle lesions is reduced by their separation in depth from surrounding normal tissue. False positive detections are reduced because layers of normal tissue are directly seen to lie at different depths in the breast and don’t superimpose to resemble a lesion. The internal structure of the breast is directly appreciated in depth.
Product page: Stereoscopic Digital Radiography system …
Emory press release: New Mammography Technology Improves Cancer Detection …
BBN press release: False-Positive Reports of Breast Lesions Reduced by 49 percent in Clinical Trial …
At the RSNA in Chicago this week, GE Healthcare is showing off technology that will soon find its way into a production CT scanner. Promising greater resolution and lower exposure dosage thanks to a new detector material, and judging by what’s being released by the competition, it looks like GE has decided to take a different research approach from the others, perhaps choosing not to compete on slice numbers and focusing more on detection.
In this case, said Gene Saragnese, GE’s vice president of molecular imaging and computed tomography, researchers have found a way to boost image clarity while reducing the dose of X-ray radiation a patient experiences.
The key to this magic lies in a new material the company has developed that serves as a detector of the X-rays after they pass through a patient’s organs.
GE describes its gemstone detector as a “4,600-karat megagarnet,” but it is a synthetic creation rather than a decorative gem.
“It’s the first new detector material in 20 years,” said Saragnese. “We anticipate it will mean a 50 percent radiation dose reduction for patients.”
The new scanner is a work in progress that has yet to be approved by the Food and Drug Administration, Saragnese said, but the company hopes it will whet the appetites of the docs and technicians kicking the tires at McCormick Place.
More at Chicago Tribune…
Details of the technology at Medical Physics…
The New Yorker has a short article on psychiatrists showing television sitcoms to schizophrenic patients, and then discussing with them the awkward social situations that are often displayed. There is some evidence that patients can more easily relate to situations they see on television. David Roberts, a second-year clinical-psychology student at the University of North Carolina at Chapel Hill, was fishing for the finest source of social ineptness available on television, and discovered Larry David’s Curb Your Enthusiasm, a show highly admired around here.
From the article:
So Roberts began showing TV clips during therapy sessions. Soon he had narrowed his selections down to one show: television’s purest expression of social dysfunction, “Curb Your Enthusiasm.” Roberts considers Larry David to be the perfect proxy for a schizophrenic person. “On his way into his dentist’s office, he holds the door open for a woman, and, as a result, she’s seen first,” he said. “He stews, he fumes, he explodes. He’s breaking the social rules that folks with schizophrenia often break.” He went on, “Or the one where Ted Danson and Mary Steenburgen invite Larry and his wife to a concert: the night arrives, they don’t call, Larry assumes they don’t like him, then it turns out he got the date wrong. It’s a classic example of a major social cognitive error-jumping to conclusions-that schizophrenic patients are prone to.” As the patients watched David flub situation after situation, they laughed, and they willingly discussed with Roberts how they might behave in the same circumstances. “That bald man made a mountain out of a molehill!” one woman called out during a session…
Larry David, reached on the telephone in California, said that he hadn’t realized how deeply the awkwardness on his show would affect people. “It just deals with how you’re supposed to behave,” he said. “A lot of the time, it’s just me expressing myself freely. I knew that my own mental health was problematic, but should I be worried? I mean, I blow up, too! Is this something undiagnosed? Do I need to see a clinical psychologist?”
More in The New Yorker…
St. Jude Medical Scores with the FDA on Valves with Anti-Calcification Technology
by on Nov 28, 2007 • 11:43 am
Newly approved Epic™ stented tissue valves from St. Jude Medical, Inc. are identical in design to the super popular Biocor™ valves, but they also feature Linx™ antimineralization technology.
From the press release:
Like the company’s Biocor Valve with the FlexFit™ Stent, the Epic Valve features the industry’s lowest overall valve height, enhancing implantability. In the mitral position, the valve’s low profile reduces the risk of obstructing blood flow into the aorta. In the aortic position, it may provide optimal coronary ostia clearance and reduce the risk of aortic wall protrusion. The new valve will be available in aortic [side image --ed.], aortic supra [upper image --ed.] and mitral models.
More about the anticalcification technology:
At the leading edge of heart valve technology, St. Jude Medical incorporates an innovative anticalcification process into the SJM Epic valve. Developed and patented by Robert Levy, MD, Linx technology works to provide a shield against calcification.
Research suggests that glutaraldehyde, calcium, and phospholipids play important roles in the calcification of bioprosthetic valves. Linx technology acts in multiple ways to combat the calcification process. This technology involves ethanol treatment of glutaraldehyde fixed valves. It has been shown extremely effective in preventing leaflet calcification in sheep mitral valve replacement models and rat subdermal studies.
Unlike any other current anticalcification technology, innovative Linx technology is believed to have multiple effects on cusp tissue, providing a powerful shield against valve mineralization. The action of Linx technology:Reduces glutaraldehyde toxicity associated with calcification Removes 99% of the cholesterol and 94% of the phospholipids, which are potential binding sites associated with tissue calcification Greatly reduces the subsequent uptake of lipids in vitro Results in stable changes to the collagen triple helix, as evidenced through infrared spectroscopy
Product page: SJM Epic™ Valve …
Linx™ Technology …
Press release: St. Jude Medical Announces FDA Approval of Epic Stented Tissue Valve with Anti-Calcification Technology …
