The first human studies of a new device that may provide many women with a minimally invasive alternative to the traditional forms of Clinical Studies Will Test "Smart Probe" Minimally Invasive Breast Biopsy Alternative (dateline January 31, 2001) | Breast Health News | Imaginis - The Women's Health & Wellness Resource Network

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Clinical Studies Will Test "Smart Probe" Minimally Invasive Breast Biopsy Alternative (dateline January 31, 2001)

The first human studies of a new device that may provide many women with a minimally invasive alternative to the traditional forms of breast biopsy are scheduled to begin this Spring. The "Smart Probe" technology was originally developed by NASA and involves inserting a tiny needle into a suspicious area of the breast, as determined by mammogram or physical exam. The needle sends out light which bounces off the breast tissue, providing electrical, optical, and chemical measurements that help physicians determine whether a breast biopsy should be ordered, based on the likelihood of cancer. If human studies are successful, the procedure could help reduce the number of unnecessary breast biopsies.

According to BioLuminate, Inc., the company who has received licensing rights for the technology, the "Smart Probe" needle is smaller than a needle used for routine blood tests. After identifying a suspicious area of tissue by mammogram or physical exam, the needle is inserted into the breast tissue. If the suspicious lesion is palpable (i.e., a breast lump), the needle is inserted directly into the lump. For non-palpable lesions, ultrasound or mammography may be used to help guide the needle to the correct area in the breast.

Once in the breast tissue, the "Smart Probe" analyzes the lesion using laser light. The probe takes several real-time measurements that help determine the probability of cancer. These measurements include oxygen partial pressure, electrical impedance, temperature, and light scattering and absorption properties, including deoxygenated hemoglobin, vascularization, and tissue density. No breast tissue is removed during the procedure and unlike traditional biopsies which require a pathological examination of the tissue samples in a laboratory, the results of the "Smart Probe" are available immediately.

"Physicians have been seeking a way to acquire more specific information about a suspected cancer site before performing a biopsy or surgery," said Neil Gorrin, MD, Assistant Chief of Surgery at Kaiser Permanente Medical Center in South San Francisco, in a Lawrence Livermore National Laboratory news release (Lawrence Livermore National Laboratory is a national security laboratory managed by the University of California for the U.S. Department of Energy). "The ‘Smart Probe’ not only is less invasive, but it provides several specific measurements of known cancer indicators in real time, which will improve our chances of making the right diagnosis and treatment plan for the patient," said Dr. Gorrin. Depending on the results of the "Smart Probe" procedure, a biopsy may or may not be ordered.

"By using the BioLuminate ‘Smart Probe’ before biopsies are performed on suspicious lesions, many unnecessary surgeries can be eliminated," said Richard Hular, President and CEO of BioLuminate. "Not only is this a great benefit for the patient, it also has the potential to save the U.S. healthcare system over $2 billion annually."

The average cost of a breast cancer biopsy, figuring in higher costs for surgical and core needle procedures, is $2,620. If the BioLuminate procedure receives approval from the U.S. Food and Drug Administration (FDA) after it completes its clinical trials, the company estimates the cost would be approximately $525 per test, including the $250 disposable needle. The BioLuminate equipment, which includes a small electronic box containing a computer, optical components, conversion electronics and a graphics display, would cost hospitals and cancer centers less than $50,000 to obtain per system.

However promising, the "Smart Probe" procedure still needs to be evaluated for safety and effectiveness in human clinical studies. Studies are set to begin this spring in Northern California at Stanford University, University of California Medical Centers in the Bay Area and the University of California Davis Medical Center in Sacramento. BioLuminate has said the "Smart Probe" procedure is approximately 85% accurate—similar to the accuracy of a core needle biopsy procedure.

According to Robert Smith, PhD, Director of Cancer Screening at the American Cancer Society, any procedure that could increase the accuracy of breast cancer diagnoses while reducing trauma to the patient would be welcome. However, Dr. Smith stresses that the accuracy of the "Smart Probe" procedure still needs to be evaluated; large studies and additional research will help determine whether the procedure can not only increase the accuracy of breast cancer detection but also decrease the number of unnecessary breast biopsies.

Breast biopsy is the only way to definitively determine whether a patient has breast cancer. It is estimated that over 30 million mammograms are performed each year and that less than one million of those mammograms (less than 5%) are recalled to undergo a biopsy (in some instances the number of cases requiring biopsy can be as low as 2%, depending on population demographics and methods of care). Of the approximately one million breast biopsies performed each year, 65% to 80% result in benign, non-cancerous diagnoses. The Smart Probe may eliminate some of these biopsies.

Surgical breast biopsy is the most accurate form of biopsy and still accounts for the majority (60% to 80%) of breast biopsies performed today. However, with recent advances in technology, many patients are candidates for less invasive biopsy procedures, such as vacuum-assisted biopsy (Mammotome or MIBB) or core needle biopsy. If the upcoming studies and future research show the "Smart Probe" procedure to be accurate, BioLuminate expects it to be available by 2003. In the meantime, patients referred for breast biopsies are encouraged to discuss all biopsy options with their surgeon, including less invasive methods. Many patients also obtain a second opinion on that mammogram before undergoing a biopsy.

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