National Cancer Institute Approves Phase III Trial - Largest North American
Breast Cancer Radiation Study - to Validate Tumor Control of Accelerated
Internal Radiation Therapy
CHICAGO, Nov. 29 /PRNewswire-FirstCall/ -- Fischer Imaging Corporation
(FIMG:PK), announced it has received clearance from the Food and Drug
Administration (FDA) for use of the MammoTest Breast Biopsy System as a
platform for Interstitial Breast Brachytherapy, a promising new treatment for
breast cancer offering a less invasive, four day alternative to the
traditional six week external beam radiation therapy, here at the 90th
Scientific Assembly and Annual Meeting of the Radiological Society of North
America (RSNA), Nov. 28 - Dec. 2, 2004.
Developed by Robert Kuske, MD, professor of radiation oncology at the
University of Arizona, Interstitial Brachytherapy involves the precise, Xray
guided insertion of catheters to irradiate and control malignant tumors in the
breast using the MammoTest digital imaging system. While traditional external
beam radiation therapy irradiates the entire breast and can last up to six
weeks, brachytherapy lasts only 4-5 days and involves only the tissue within
two centimeters of the lumpectomy site.
"Interstitial Brachytherapy has demonstrated excellent tumor control over
13 years with a three percent reoccurrence rate in breast cancer compared to
traditional radiation therapy utilizing external beam, which has about a 10
percent reoccurrence. The therapy is effective because it extends intense
treatment an additional two centimeters around the lumpectomy site to include
the tissue that is at the greatest risk for relapse," said Dr. Kuske, a
radiation oncologist at the Scottsdale offices of the Arizona Oncology
Services and Foundation for Cancer Research. "The MammoTest breast imaging
system is very important to the effectiveness of the procedure as surgeons
must have high quality, high resolution images to accurately place the
catheters in a prone position. The MammoTest system provides the best images I
have seen."
According to Dr. Kuske, Phase II trial results were so promising that the
National Cancer Institute recently approved a Phase III trial to compare
brachytherapy and external radiation therapy for the treatment of breast
cancer. Involving more than 3,000 patients, it is the largest North American
breast cancer radiation trial. "If the results of this trial maintain the
same level of tumor control with low reoccurrence rates, I strongly expect
brachytherapy to rapidly become one of the leading breast cancer treatments
because it is easier on patients with better cosmetic outcomes and fewer side
effects."
Also this week at the RSNA meeting, Dr. Kuske is presenting an abstract,
titled "Use of the Stereotactic Breast Core Biopsy Table to Perform Image-
Guided Breast Brachytherapy (BT) in the Prone Position for Select Carcinomas
of the Breast." In his educational exhibit, Dr. Kuske demonstrates the
integral role of the MammoTest biopsy table to the reproducibility and broad
accessibility of the breakthrough therapy.
According to the American Cancer Society, breast cancer is the most
frequently diagnosed cancer in US women, with 211,300 invasive cases expected
in 2003, accounting for nearly one in every three cancers diagnosed. Each
year, more than one million women undergo breast tissue biopsies. Statistics
currently indicate that 80 percent of breast biopsies result in benign, or
non-cancerous findings, reinforcing the need for minimally invasive
techniques.
The MammoTest Stereotactic imaging system was originally introduced and is
primarily used at the diagnostic stage of breast cancer screening. When
suspicious calcifications are found using traditional screening mammograms
radiologists order a higher resolution image of the suspicious area. In some
cases, cancer is ruled out at this stage. In others, a biopsy is performed
using the MammoTest imaging system to precisely locate a biopsy needle and
extract the tissue in question for testing.
"We are proud to work with Dr. Kuske, an internationally renowned cancer
researcher, on the development of this breakthrough treatment for breast
cancer," said Harris Ravine, Fischer Imaging president and CEO. "Clearance
from the FDA for use of the MammoTest digital imaging system as a platform for
Interstitial Breast Brachytherapy marks a significant step in offering women
who suffer from breast cancer a breakthrough therapy that carries excellent
tumor control and minimal side effects."
About Fischer Imaging
Fischer Imaging Corporation designs, manufactures and markets medical
imaging systems for the screening and diagnosis of disease. One company focus
is women's health, particularly the diagnosis and screening of breast cancer
through the application of innovative digital imaging technologies. The
company also produces equipment designed for Emergency, Radiology, Surgical,
and certain Cardiovascular needs. Fischer Imaging began producing general-
purpose x-ray imaging systems in 1910 and is the oldest manufacturer of x-ray
imaging devices in the United States. For more information, visit
http://www.fischerimaging.com.
SOURCE Fischer Imaging Corporation
 back to top
Related links:
http://www.fischerimaging.com
CONTACT:
Chris K. Joseph, +1-650-776-3259 or
chris@ckjcomm.com, for Fischer Imaging
|
