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.
Under a cooperative research and development agreement announced at the Lab Wednesday, Livermore 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.
“Let me quote a few numbers: 21, 460 surgeries happen on women’s breasts every week in this country and they are not necessary. In that same week, we miss about 4,600 cancers and that’s really significant,” said Richard Hular, President and CEO of BioLuminate. “The technology that Bioluminate has along with what Lawrence Livermore is adding to the equation will allow us to drive those numbers to zero. That’s what we’re really excited about.”
The device is expected to be commercially available by 2003. 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.
The first human studies using the device are expected to begin this spring at sites to be selected in Northern California. “Physicians have been seeking a way to acquire more specific information about a suspected cancer site before performing a biopsy or surgery,” said Dr. Neil Gorrin, 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,” Gorrin added.
Bill Goldstein, principle deputy AD for Physics and Advanced Technologies, said, “This project is an exemplar of the many projects at the Lab that exploit unique laboratory capabilities and technologies to improve the quality of people’s lives. Livermore laboratory places a very high value on its work in medical technology research. It’s one of the core missions of the Laboratory to advance bioscience to improve human health. Partnering with the private sector on medical technology is one of the best ways for us to get our capabilities to those who really need them.”
Goldstein also noted that the medical technology projects play an important role in recruiting and retaining scientists at the Lab, and that the same scientists working on new medical technologies also work in the national security programs.
Fewer unnecessary biopsies
Breast cancer is the second leading cause of death among women in the United States. Last year in the United States, 182,800 women were diagnosed with breast cancer and more than 40,800 died of the disease.
In the United States 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,” Hular said. “Not only is this a great benefit for the patient, it also has the potential to save the U.S. health-care 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 (five to seven) 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, the Lab’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.
“I see this as the first major step in 20 years toward finding a technology that can pinpoint whether a tumor is malignant or benign,” Gorrin said.
BioLuminate, Inc. is a private San Jose startup 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.