Satish Kandlikar is committed to the collective fight against breast cancer.
The Gleason Professor of Mechanical Engineering at Rochester Institute of Technology launched Bired Imaging roughly a month ago, which uses thermography and a proprietary algorithm to detect tumors in breasts.
Targeted as a complement to mammography, Bired Imaging posits that a nonradiative, nonintrusive and low-cost technology will reduce unnecessary biopsies and patient discomfort.
Kandlikar began to study the application of thermography as a screening modality in 2014, with a high-end infrared camera once used for fuel-cell research. (Thermography uses an infrared camera to detect heat patterns and blood flow in body tissues.)
“From space we can identify a ship from a thermal profile, so right here the cancer tumor generates heat and gives out a signature,” Kandlikar says. “Why shouldn’t we be able to detect that mathematically? So, that was our premise.”
In collaboration with student researchers and physicians at Rochester Regional Health, Kandlikar secured a $100,000 grant from the National Science Foundation through its Early Concept Grants for Exploratory Research program. These grants fund early-stage transformative work. The NSF research project also had an institutional review board. IRBs are groups that review and monitor research involving human subjects.
The team screened patients and correlated infrared images against original magnetic resonance imaging scans to validate its process and technology. Patients in the Rochester Regional Health Breast Center volunteered to be tested after an initial mammography discovered suspicious findings. When referred for a follow-up MRI, these patients could volunteer to be screened using the infrared system.
The Bired Imaging system uses advanced computer simulation, much like artificial intelligence, to predictively analyze tumor location and growth. By gathering such data, physicians can assess the presence of a tumor and the advancement of the disease, and determine interventions accordingly.
“We can predict how deep (the tumor) is, its exact location and its diameter within a few millimeters,” Kandlikar says.
The current standard
Currently, mammography is the standard for breast cancer screening, rooted in the fact that it is able to spot early signs of the disease. However, the technique has limitations. It sometimes fails to accurately detect tumors in breasts with high amounts of glandular and fibrous connective tissue, also called dense breast tissue.
Women with dense breasts—estimated at 40 percent of the female population—are at higher risk for cancer. Only mammograms can determine breast density.
“The problem with dense breast tissue is that when you do a mammogram, it’s a source of confusion because in a dense breast it’s very difficult to see a cancer,” says Lori Medeiros M.D., system executive director for RRH’s breast service line, who has partnered with Kandlikar.
She points to the dense breast legislation, which requires imaging facilities to give some level of notification to patients and providers after a mammogram.
“The problem is that we don’t have really great alternatives for these women in imaging by and large,” Medeiros says.
Physicians have the option to add ultrasound as a second line of investigation. The challenge there is that the technique is operator-dependent, Medeiros says. Larger radiology groups may have a dedicated ultrasonographer for breast exams while smaller units might use one technician for all types of ultrasounds, increasing the margin of error. Reproducibility in such situations is another factor—operators may not conduct exams similarly.
“The other thing about it is that ultrasound is very time consuming,” Medeiros says. “Ultrasound screening for the whole breast, depending on breast size, can take up to an hour to do because what you’re trying to do is basically cover an entire breast with a tiny little credit card size beam.”
She laments the absence of a second-line screening tool for the average-risk woman.
“The best second-line screening tool is an MRI, which is quite expensive,” Medeiros says. “It is really restricted for patients where their lifetime risk of developing breast cancer is 20 percent or higher … because not only is it expensive, it tends to be a little over-sensitive.”
In other words, women who get an MRI screening that looks abnormal might end up being falsely alarmed.
“So, that’s why that 20 percent cutoff is used because at about that level the risk of a false positive versus the risk of missing something balances itself out so that you’re not subjecting a huge percentage of population to additional biopsies and tests that are unnecessary,” Medeiros says.
Filling a void
Thermography has been around for several decades. Thermal images visually display the amount of infrared energy emitted by an object. As cancer cells multiply in a breast to create a mass, blood flow to the tumor increases, causing the temperature around it to rise, rendering it measurable.
Once considered a promising screening tool, it was dismissed because of poor results, Kandlikar says, citing a lack of proper protocols and a high-quality infrared camera. Before maintaining a steady temperature for a thermogram, cold air was blown on patients.
“We think this technology historically has gotten a bad reputation because in the ’70s and ’80s people were using infrared in a very primitive way and doing manual readings,” says Pradyumna Phatak M.D., medical director of the Lipson Cancer Institute and one of Bired Imaging’s collaborators. “There were lots of false-positive results and therefore mammography was recommended as a screening tool of choice, but they didn’t discard thermography.”
The U.S. Food and Drug Administration approved the technique as an adjunctive and not as a standalone tool. Though several thermal boutiques have sprouted here and around the nation, the technology has largely remained on the sidelines.
Bired Imaging offers a new perspective on thermography. It uses steady-state infrared imaging in the prone position, allowing for direct optical access to the inframammary fold and thermally isolated breasts. In doing so, it eliminates undesired thermal artifacts resulting from the breast contacting the chest surface. The patient’s position is favorable for accuracy over the upright position commonly used in other infrared imaging modalities. The technique uses natural heat emitted by the body, and not cold stress.
Additionally, when it comes to density, thermography is unaffected by it—dense tissue does not change an infrared reading.
Bired Imaging’s system generates a digital breast model that is used for thermal simulation and mathematical analysis. So far, using numerical heat transfer software and inverse modeling, this technology has been validated against seven biopsy-proven test cases.
“The unique part of Satish’s work is that he’s using a computer algorithm to then use the temperature data to then predict whether there’s a cancer or not,” notes Phatak, who is a board member at Bired Imaging. “It seems to be extremely effective. So, you’ve taken the human element of reading a thermogram away.”
The system, Medeiros says, helps produce better images. The team tested women with breast cancer who underwent MRI and found that the results through that screening were similar to those obtained by Bired Imaging’s system.
“With thermography, with this new algorithm, if you add that on to mammography and you use that as an adjunct tool and not as the primary tool, the idea is that you’re going to be able to catch more cancers the way ultrasound would, without necessarily incurring the same expense in communities that don’t have access to experienced ultrasonographers,” Medeiros says.
A cost-effective, reproducible, noninvasive technique would be able to benefit half of the female population in the nation, she adds.
The average risk of a woman in the United States developing breast cancer sometime in her life is roughly 13 percent, according to the American Cancer Society. Some 276,480 new cases of invasive breast cancer will be diagnosed in women this year, the organization estimates. More than 42,170 women will die from the disease. Screenings are key to detecting cancer early.
“Breast cancer and physicians who deal with breast cancer tend to be always interested in something new,” Medeiros says. “Any questions physicians would have is what’s the reproducibility and how accurate is it.”
The next step for Bired Imaging: a large-scale clinical test. Kandlikar is intent on developing a seamless product that takes images, analyzes them and presents a result by using an already approved adjunctive technique. The company has applied for U.S. and international patents.
Kandlikar views it as a winning solution for patients who won’t be subjected to biopsies without reason, additional information for radiologists and lower costs for insurers.
“This is an adjunctive technology and I respect that,” he says. “I’m not trying to enter with a plan to subvert the system.”
If Bired Imaging is successful, the technology could also reach underserved populations in rural areas here and overseas.
Widely known in academic circles for his work on flow boiling heat transfer, Kandlikar has been lauded for his contributions to the field. He is the recipient of numerous awards at RIT and has received the Heat Transfer Memorial Award from the American Society of Mechanical Engineers, among others.
With Bired Imaging, Kandlikar says he will do what it takes to get it to market.
“This is, in a way, my life’s mission—to make sure this technology sees the light of day and gets a fair evaluation,” he says.
Smriti Jacob is Rochester Beacon managing editor.