Smart Probe for Breast Cancer Detects Malignant Tumors Instantly

January 2001 -- The pain and anxiety women experience undergoing breast cancer tests and awaiting the results may soon be lessened thanks to a new, minimally invasive diagnostic tool that can instantly detect cancerous tissue, according to the developer Lawrence Livermore National Laboratory.

L.L.N.L. has partnered with San Jose-based BioLuminate, Inc. to develop "Smart Probe," a tool for earlier, more accurate breast cancer detection that removes no tissue and is expected to achieve accuracy levels comparable to surgical biopsies in detecting cancerous cells.

The BioLuminate "Smart Probe," smaller than the needle used in routine blood tests, is inserted into breast tissue after an initial screening indicates an area of concern. The probe looks for multiple known indicators of breast cancer, instantaneously providing physicians with information they can use to determine whether more invasive and costly tests are necessary. The results of the "Smart Probe" procedure are immediately available to patients, helping relieve anxiety.

First human studies using the device are expected to begin this spring at sites to be selected in Northern California. Eventually, the "Smart Probe" also is expected to be used on prostate, lung, colon, cervical and brain cancer patients to detect malignancies and deliver and monitor treatment.

"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.

"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."

Fewer Unnecessary Biopsies

Breast cancer is the second leading cause of death among women in the United States. Last year in the U.S., 182,800 women were diagnosed with breast cancer and more than 40,800 died of the disease.

In the U.S. each week, approximately 16,000 women undergo unnecessary, surgical breast biopsies on suspicious tissue that turns out benign. In addition, physicians miss about 4,600 cases of breast cancer each week during physical examinations and mammogram reviews.

"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."

Cancer Indicators Measured in Real Time

Once a mammogram or physical exam has detected a possible malignant lump, "Smart Probe" is inserted into the tissue and guided to the suspicious region. Sensors on the tip of the probe measure optical, electrical and chemical properties that are known to differ between healthy and cancerous tissues. The "Smart Probe" can detect multiple (5 to 7) known indicators of breast cancer. Tissue measurements are made in real time in both normal and suspect tissue.

"Smart Probe's" sensors begin gathering information the moment the probe is inserted into tissue. Computer software compares the real-time measurements to a set of known, archived parameters that indicate the presence or absence of cancer. The results are displayed instantly on a computer screen.

"The key technology and experience that Lawrence Livermore Lab has to offer will allow the 'Smart Probe' to be much smaller than first conceived, and acquire data more accurately," said Luiz Da Silva, Ph.D, Livermore's Associate Medical Technology Program Leader and primary investigator for the "Smart Probe." "In addition, we will have the capacity to add additional measurements if necessary." Human Trials to Begin This Spring

Lawrence Livermore has signed a research and development agreement with BioLuminate to use the Laboratory's propriety optical imaging and probing technology to develop "Smart Probe" for all cancer detection applications.

BioLuminate and Livermore researchers are designing and fabricating the first "Smart Probe" prototype. The first human studies are expected to begin this spring at sites to be selected in Northern California. The device is expected to be commercially available by 2003.

Founded in 1952, Lawrence Livermore National Laboratory is a national security laboratory, with a mission to ensure national security and apply science and technology to the important issues of our time. Lawrence Livermore National Laboratory is managed by the University of California for the U.S. Department of Energy.

BioLuminate, Inc. is a private San Jose, Calif. start-up firm that is developing the "Smart Probe" in collaboration with LLNL and NASA Ames. The company has an exclusive license to NASA's "Smart Surgical Probe" technology for all cancer applications and has the exclusive rights to develop LLNL's optical imaging and probing technology for all cancer detection applications.

For more information: www.bioluminate.com and www.LLNL.gov