LAS VEGAS, March 15 /PRNewswire/ -- Results of two clinical studies demonstrate the value of Breast-Specific Gamma Imaging (BSGI) in the identification of two hard-to-detect cancers: Ductal Carcinoma in-Situ and Invasive Lobular Carcinoma (ILC).
Dr. Rachel Brem and her colleagues from the department of radiology at The George Washington University, Washington, D.C. presented results of two studies from a group of 117 women with breast cancer at the annual meeting of the National Consortium of Breast Centers (NCBC).
BSGI is a nuclear medicine procedure that images the metabolic activity of breast lesions through radiotracer uptake, specifically imaged using a high- resolution, small field-of-view gamma camera, the Dilon 6800. This technique can help doctors more reliably differentiate cancerous from non-cancerous cells. While other adjunctive diagnostic modalities, such as MRI and Ultrasound, image the physical structure of the breast, BSGI captures the cellular functioning of the breast tissue.
The two studies presented by Dr. Brem and her colleagues at the NCBC are as follows:
Evaluation of Ductal Carcinoma in-Situ (DCIS) With Breast Specific Gamma Imaging Using a High Resolution Gamma Camera
A total of 117 women were included in this study, which was designed to evaluate the ability of BSGI to detect Ductal Carcinoma in-Situ (DCIS). DCIS, which often manifests on mammograms as microcalcifications, can often be more extensive than indicated on a mammogram. In addition, a key adjunctive test, Magnetic Resonance Imaging (MRI), is limited in its ability to detect DCIS. While MRI has a sensitivity of greater than 90 percent for invasive cancers, it has a sensitivity of only 64 percent for DCIS, according to the study authors.
All 117 women in the study had breast lesions warranting biopsy as detected by mammography or ultrasound. All patients underwent BSGI with the Dilon 6800 gamma camera. Of the 117 women, 13 women (11.1 percent) had pure DCIS with no evidence of invasion. Mean pathologic size was 8.8 mm (1-22mm). Of the 13 women with DCIS, 12 were positive with BSGI. These results indicate the sensitivity of BSGI for DCIS is 92.3 percent.
BSGI, a physiologic approach to breast cancer detection, has a higher sensitivity in detecting DCIS than MRI, the authors said. In addition, the authors concluded, BSGI appears to be a highly sensitive imaging technique in detecting DCIS, even when the cancer is less than one centimeter in size.
Detection of Invasive Lobular Carcinoma (ILC) Using a High-Resolution, Breast Specific Gamma Camera
A total of 117 women were included in this study, which was designed to examine the ability of BSGI to detect Invasive Lobular Carcinoma (ILC). ILC is more likely than other types of breast cancer to be missed on a mammogram because it does not form calcifications and has no well-defined mass.
All 117 women in the study had breast cancer warranting biopsy. All underwent BSGI with the Dilon 6800 and the images were classified using a 1-5 scale: (1) normal, (2) benign with minimal patchy physiological uptake, (3) probably benign with scattered patchy uptake, (4) probably abnormal, with mild focal radiotracer update; and (5) abnormal with marked focal radiotracer uptake.
Of the 117 women, five (4.3 percent) had lesions that on pathology were found to be pure ILC. Mean size of the ILC was 22.1 mm (range 15 - 60 mm). All five lesions (100 percent) had BSGI studies that were classified as 4 or 5 -- positive in the same quadrant of the breast and the same distance from the nipple. There were no false negative BSGI studies in women with ILC.
The authors concluded that BSGI is a highly sensitive imaging modality in detecting ILC, a cancer that is often difficult to detect mammographically, with ultrasound or with physical examination. In addition, larger studies are underway to further evaluate BSGI in the diagnosis on ILC, the authors noted.
In commenting on these two studies, Dr. Brem said, “Mammography will remain a mainstay for breast cancer screening. However, it remains an imperfect examination with 10 percent to 15 percent of breast cancers not mammographically visible. Therefore it is vital that adjunctive imaging modalities, such as the Dilon 6800, be fully explored as ways to improve diagnosis.”
About BSGI with the Dilon 6800 Gamma Camera
Breast-Specific Gamma Imaging (BSGI) is a molecular medicine procedure that images the metabolic activity of breast lesions through radiotracer uptake, using a high-resolution, anatomic-specific gamma camera. A small amount of tracing agent is delivered to a patient, and in turn is absorbed by all cells in the body. The tracing agent emits invisible gamma rays, which are detected by the Dilon 6800 and translated into a digital image of the breast. Due to the higher metabolic activity of cancerous cells, these cells absorb a greater amount of the tracing agent and are revealed as “hot spots.” This technique can help doctors more reliably differentiate cancerous from non- cancerous cells. While other adjunct modalities, such as MRI and ultrasound, image the physical structure of the breast, BSGI captures the cellular functioning of the breast tissue.
Although mammography is a highly effective screening tool, in some cases it can provide low specificity in detecting breast cancer, as indicated by the high false positive rate of biopsy. In cases where post-mammogram evaluation is indicated, BSGI acts as a vital diagnostic adjunct with a specificity of 92 percent, as demonstrated through multiple clinical studies, and provides a high sensitivity for identifying earlier stage cancers -- as small as 3 mm.
About Dilon
Dilon Technologies, LLC, is bringing innovative new medical products to the market based on research conducted at leading national research laboratories. Dilon’s cornerstone product is the Dilon 6800 Gamma Camera to perform BSGI, a molecular medicine procedure that images the metabolic activity of the breast lesions through radiotracer uptake, using a high- resolution, anatomic-specific gamma camera. Several leading medical centers around the country are now offering BSGI to their patients, including: Beth Israel Medical Center, New York; George Washington Medical Center, Washington, D.C.; Alexian Brothers Medical Center, Chicago; Breast Health Institute, Orlando; and West Valley Imaging, Las Vegas. For more information on Dilon visit www.dilon.com.
Dilon Technologies, LLC
CONTACT: Nancy Morter of Dilon Technologies, LLC, +1-757-269-4910, ornfmorter@dilon.com
