Research Demonstrates Percentage of Breast Cancer Biopsies Seen Only on PEM Imaging
SAN DIEGO, CA – March 31, 2011 – The Breast Journal recently published original prospective data confirming the technical validity of image-guided needle biopsy of suspicious breast cancer lesions using Positron Emission Mammography (PEM)-guidance. The study, which used the Naviscan high-resolution breast PET scanner, otherwise known as a PEM scanner, marks the first time PET imaging alone has been able to target regions in the breast with abnormal FDG uptake and guide the extraction for histopathologic analysis.
The main objective of the study was to confirm successful targeting and lesion sampling. A second objective was to confirm the safety and patient comfort during the procedure.
Six physicians, using three different commercially available vacuum-assisted biopsy tools, conducted this study at five sites. A total of 24 PEM-guided biopsies were completed with 100% success.
The most important advantage of PEM-guided biopsy is the ability to target and biopsy lesions that are difficult to see on other imaging tools giving patients and physicians another option in the fight against breast cancer.
The Breast Journal published data on the role of PET image-guided needle biopsy in the diagnosis and pre-surgical planning of women with breast cancer.
This clinical study of (PEM)-guided biopsy is the first use of PET imaging alone to target regions in the breast with abnormal FDG uptake and guide the extraction of such tissue for histopathologic analysis.
Percutaneous breast biopsy has been shown to reduce costs and morbidity of breast cancer diagnosis compared to needle-localized excision.
A total of 24 PEM-guided biopsies were completed with 100% success. One of the malignancies was seen only on PEM imaging, and another was seen better on PEM than on MRI.
“I am so thankful that I was able to have this procedure. The type of cancer that I had is called triple negative and apparently is a very aggressive form of cancer. Had I not had the PEM scan and the PEM biopsy, who knows what my prognosis would have been had the cancer not been detected. I truly feel that these innovative PEM procedures most likely saved my life.”
Study Patient Sally Ryser from Boca Raton, Florida
“PEM-guided biopsy is quite elegant and confers several advantages over MRI-guided biopsy. We can easily image the breast after sampling to assure removal of the target, and resample at the same setting if needed. With PEM, we also have the ability to directly image the specimens, which both further confirms successful sampling and allows us to direct the pathologist's attention to the ‘hot’ specimens.”
Dr. Wendie Berg, co-author
Naviscan, founded in 1995, develops and markets compact, high-resolution PET scanners intended to provide organ-specific molecular imaging and guide radiological and surgical procedures. The Naviscan PET scanner is currently installed and available in breast and imaging centers throughout the world with global distribution in 34 countries. The Company is headquartered in San Diego, California and is the first to obtain FDA clearance and CE Mark for a high-resolution PET scanner designed to image small body parts and for breast biopsy image guidance. For more information, visit www.naviscan.com.
31st March 2011
Joleen Schultz
Naviscan Marketing Communications
858.455.5500
Guillaume Bailliard
EVP, Marketing
858.332.0941
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