Technologies, a leading provider of advanced technology, research and development, today announced the beginning of a new stereoscopic digital mammography (SDM) clinical trial. The trial will take place at Emory University's Breast Imaging Center in Atlanta, GA, and is projected to continue through July 2007.
SDM is a mammography system that provides a three-dimensional, in-depth image of the breast. Previous work has shown that this new system, which is not yet FDA approved, enables a radiologist to detect and interpret breast lesions that a standard digital mammogram may fail to capture. This clinical trial will seek to confirm these findings.
The trial, which will enroll 2,000 participants, will target women with an elevated risk for developing breast cancer. Participants will receive both a standard digital mammogram and a stereoscopic digital mammogram.
Breast cancer is the second leading cause of cancer death in women, according to the American Cancer Society. One woman in eight in the United States will be diagnosed with breast cancer in her lifetime. Early detection and diagnosis is the single most relevant factor in predicting long-term survival.
"SDM is different from any other existing mammography system in its ability to provide the radiologist with a true, direct, in-depth view of the breast volume- just as you experience depth in your everyday visual experience of the world because your two eyes, being separated, see the world from slightly different viewpoints," said Dr. David Getty, principal investigator of the SDM project. "The radiologist sees, at once, all of the structure within the breast laid out in depth. He or she can directly appreciate the spatial relationship of one object to another in the volume - for example, the geometric structure of a cluster of microcalcifications, which we think may be very important in determining the presence of breast cancer.
Interpreting standard mammography images presents a challenge to radiologists, as subtle lesions in the breast may be masked by overlying or underlying normal tissue. An additional challenge arises when these layers of tissue resemble a lesion, leading to a false positive diagnosis. Stereoscopic mammography may overcome these challenges by providing a view that separates tissue in depth, making subtle lesions more visible and their characteristics far clearer, thereby aiding the radiologist's ability to detect subtle lesions and distinguish between benign and malignant lesions.
BBN's SDM system was developed by Dr. David Getty, a division scientist at BBN and a prominent researcher in the field of medical imaging. He is a fellow in the American Association for the Advancement of Science and the American Psychological Society. Dr. Getty, who holds a patent in stereo radiography, is the principal investigator of the SDM project. "Our first preliminary study using the system was conducted from 1996 to 2000 at UMass Medical Center with very promising results," said Dr. Getty.
Added Dr. Getty, "In the current standard mammography exam, two images of the breast are taken from two different viewpoints. The radiologist must examine the two images individually and must then infer from the two images how the tissue is arranged in the breast volume. With the new technology, a stereo pair of images is taken and then displayed on the new stereo mammography display system developed by BBN, using stereo display technology developed by Planar Systems.. The resulting three-dimensional image enables the radiologist to see directly how the tissue is distributed in depth in the breast."
Dr. Getty conducted the preliminary study of SDM with Dr. Carl D'Orsi, the director of Breast Imaging at Emory's Winship Cancer Institute and primary clinical investigator of the SDM trial. Dr. D'Orsi is a Fellow of the American College of Radiology, a founder of The Society of Breast Imaging and Professor of Radiology and Hematology/Oncology at Emory University in Atlanta.
"SDM is a promising new technology in the fight against breast cancer, and the start of this clinical trial is very exciting," said Dr. D'Orsi. "The goal of our study is to provide a thorough evaluation of this new x-ray mammography technique in a screening setting. Our hope is that it will prove to be a significant improvement in the early detection of breast lesions."
Dr. D'Orsi added, "We also hope that the added information in the stereo mammogram may give mammographers more confidence in their interpretation, resulting in less frequent recall of women for further work-up. "
For additional information or to enroll in the trial, please call the Breast Imaging Research Department at Winship Cancer Institute at 1 (404) 778-3009.