Mammography

Kodak readies FDA pitch for CR mammographyThe next step in Kodak’s push to expand its market for computed radiography in mammography to the U.S. is under way. The company has begun the submission process to the FDA to approve its CR system for the detection of breast cancer. It plans to submit a series of “modules” for agency review. The first ones will contain manufacturing and nonclinical information regarding the DirectView CR 850, CR 950, and CR 975 systems. Kodak, which is selling CR mammography products outside the U.S., is currently conducting clinical trials of its digital mammography system at sites in the U.S. and Canada.If and when these systems appear in the U.S., they will not be the first such products (DI SCAN 10/10/05). Fuji began marketing CR technology for mammography in 1983 but voluntarily removed those products in the mid-1990s, when the FDA changed its position on digital mammography and required PMA review. Fuji turned in the final module of its premarket approval submission in March. Fuji executives believe approval of their CR mammography product is imminent.

Ablating the safety margins of tumors following lumpectomy could reduce the need for another resection. The combined treatment approach could also reduce breast disfigurement, according to a study presented at the American College of Surgeons annual meeting in October.

Dynamic Imaging prepares enhanced RIS/PACSVisitors to the Dynamic Imaging exhibit booth at the RSNA meeting will see the company’s version of its IntegradWeb RIS/PACS. The system builds on the Web-based architecture of its predecessors to address ambulatory settings. Included in the IT package are RIS, PACS, billing, document management, and digital dictation.

CONTEXT: Cerebral tissue damage due to stroke occurs in two stages: Lack of blood causes initial damage, and delayed cell death, presumably by apoptosis, follows in neighboring regions. Dr. Francis Blankenberg, an associate professor of radiology and pediatric medicine at Stanford University, used technetium-99m-rh-Hynic-Annexin V, an imaging marker that binds to cells at an early stage of apoptosis, to identify at-risk tissue surrounding the initial damage caused by stroke. Tc-99m-rh-Hynic-Annexin V attaches to phosphatidylserine, a phospholipid that is expressed on the membranes of neuronal cells undergoing apoptosis and is viewed using SPECT.

Digital mammography's superiority over film in cancer detection in select patients took industry watchers and researchers by surprise. While proponents hoped for a best-case scenario of a clinical draw between the two techniques, few expected digital to excel.

Digital mammography is maturing. Full-field digital systems are becoming more flexible, endowed with screening and diagnostic capabilities, while physicians are experimenting with 3D capabilities that promise to eliminate poor visualization and clutter on 2D mammograms. Workstations designed to display digital mammograms are becoming more cosmopolitan. Like workstations built for CT and MR, they can exchange and display imaging data from multiple sources and modalities.

Computer-aided detection is evolving from an interesting technological trapping to a standard of care. Part of that process involves the ongoing iterative advancement expected to be on display at the RSNA meeting.

Computer-aided detection is scoring new points for lung cancer diagnosis, according to European researchers. Despite ongoing controversy, investigators also showed advances in CAD for lung cancer screening.

The last of the four FDA-approved full-field digital scanners, Siemens Mammomat Novation DR, has gained American College of Radiology accreditation. The FDA granted the ACR the right in 2003 to accredit the other three digital mammography machines approved for sale in the U.S.: GE Senographe 2000D, Fischer SenoScan, and Lorad Selenia. The ACR accredits about 95% of mammography equipment in the U.S., while the state handles the accreditation process in Texas, Arkansas, and Iowa.

The FDA has given the American College of Radiology the authority to accredit the Siemens Mammomat digital mammography scanner as of Oct. 15. It is the last of the four FDA-approved full-field digital scanners to come under the ACR accreditation umbrella.

Near-infrared light used with ultrasound can zero in on early-stage breast tumors, potentially reducing the number of biopsies, according to a study in the October issue of Radiology.

The future is a murky thing, but predictions are not. Right or wrong, they leave no room for doubt, although the assumptions underlying them may be a little shaky.

Computed radiographic mammography, although widely available in Europe and Asia, is only now coming to the U.S. market, as major manufacturers hope to win FDA approval for their devices in the coming months, weeks, even days.

The ultrasound market in the U.S. stumbled last year, with the exception of hand-carried systems. Sales of ultrasound units were flat in 2004, but demand for handheld systems grew in the double digits, according to industry sources. The physicians driving those sales included not only radiologists but relative newcomers to the ultrasound fold such as surgeons and emergency room physicians.

Breast CT, on the drawing board for decades, is now in phase II clinical testing at the University of California, Davis. Begun in early summer, the second phase of the Breast CT Project will enroll 190 patients over the next few years. As of September, researchers had scanned 17 patients who had been identified through mammography as having BI-RADS 4 or 5 lesions. Fifteen lesions have been confirmed as cancer.

A two-year prospective study validates the impact of computer-aided detection in identifying invasive breast cancer at an ever earlier stage. CAD increased the cancer detection rate by 16.1% during the study, published in the October issue of the American Journal of Roentgenology.

Mammography study boosts CAD prospectsiCAD expands partnershipFDA approves Kodak mammography CADHospital chain taps AquariusNETSectra snags U.S. distributorFonar scores in GermanyEpix appoints interim CEOVital Images installs new execsDaiichi, GE strike agreementKereos bags $19.5 million financingMerge eMed marketing initiative pays offSonoSite signs veterinary distributor

A clinical imaging study published in The New England Journal of Medicine on Sept. 16 could spark substantial new demand for full-field digital mammography.

Digital mammography represents the last frontier for diagnostic imaging departments and imaging centers that have implemented PACS. For some imaging centers, particularly those specializing in breast imaging, digital mammography provides the catalyst for converting to digital image management. Many facilities that do not have the preparation or the staff to accomplish this transition seek a ready-made solution.

I3Archive specializes in cross-enterprise distribution and access of health images and data, using distributed archiving supercomputer technology. Its National Digital Medical Archive (NDMA) is a distributed database system currently containing approximately 500,000 digital mammography (and related) DICOM images, associated demographic and clinical data, and reports. The product's name was changed from National Digital Mammography Archive in May to reflect its inclusion of breast MRI and breast ultrasound images.

Studies have failed to provide a slam-dunk for digital mammography over traditional film x-rays, according to a recent technology assessment report from the ECRI group.

Digital mammography is more accurate than film in detecting cancer in women under age 50, those who have dense breasts, and in pre- and perimenopasual women, according to the long-awaited results from the Digital Mammography Screening Trial (DMIST).

Sixty-four slice CT makes all things radiologic better. The high spatial and temporal resolutions that work so well for cardiac imaging also improve other applications, especially vascular studies.

Thirteen years after its passage by Congress, the Mammography Quality Standards Act remains a sore subject for radiologists. While breast imagers unanimously agree that the MQSA has vastly improved mammography quality, they give the rule low marks for its cost and the burdensome details of compliance.

No doubt, the Mammography Quality Standards Act has improved the quality of breast imaging. As this month's cover story clearly establishes, long-time mammographers have seen a decided improvement in clinical practice since the MQSA was adopted in 1992.