Jarrett LeClaire and his wife, Ilene, were newlyweds trying to start a family when Ilene discovered a small tumor in her right breast.
A biopsy led to the 42-year-old’s diagnosis of Stage 1 breast cancer. The Vancouver couple were dealt a series of blows over the weeks that followed. Misread tests led to a false diagnosis of inoperable Stage 4 cancer and recommendations to begin planning Ilene’s funeral.
The LeClaires were relieved to learn the original diagnosis of Stage 1 breast cancer was correct. Ilene underwent mastectomy surgery in early June 2009 and assumed she would finally be free of the cancer that had shaken her world for months.
Two days later, the LeClaires learned Ilene would need another surgery. The surgeon wasn’t able to get negative margins — a certain amount of cancer-free tissue surrounding the tumor — to ensure the cancer was completely gone.
The LeClaires also learned that second surgeries, called re-excisions, aren’t uncommon. The re-excision rate for women with early-stage, impalpable (unable to feel) cancer is about 25 percent.
“I was mad that it wasn’t over,” Jarrett LeClaire said. “And I was scared there was a possibility this cancer was still in my wife.”
“Cancer, it had been hitting us and hitting us and hitting us. Why couldn’t somebody hit cancer back?”
So LeClaire, who works in sales, decided to do just that. He teamed with an area surgeon, Dr. Jamie Khaw, and together they developed a solution: injectable polymers that would make impalpable tumors palpable.
Five years later, the duo has formed a business, Malignext Targeting Technologies, received a patent, won research grants and formed a relationship with Pacific Northwest National Laboratory, a U.S. Department of Energy research lab in Richland. They’re currently in the running for a $250,000 grant that would go a long way in getting the new technology on the market.
‘We can’t feel this’
When Ilene received an ultrasound on her breast, Jarrett remembers clearly seeing the cancer. The tumor was an irregular shape with jagged edges. He was surprised to learn identifying cancer was significantly more difficult for surgeons.
“The struggle we as surgeons have is we can’t feel this,” Khaw said.
Early-stage, noninvasive breast cancers are typically lesions that can’t be felt. Prior to surgery to remove a tumor, a surgeon will use imaging and a wire to locate and mark the cancer, Khaw said. Then, the surgeon will use that wire during surgery to estimate the location of the cancer, she said.
“It’s a little bit of a needle in a haystack situation,” Khaw said.
Since there’s no actual mass to see, surgeons rely on the images and wire marker to know where to remove tissue, Khaw said. If the surgeon doesn’t remove all of the cancerous tissue, they have to perform another procedure.
“As a surgeon, it’s something we recognize as a problem,” Khaw said. “We see it as a problem but accept it as a standard.”
In Ilene’s case, the surgeon was able to successfully get negative margins during the second procedure.
To Jarrett LeClaire, a second surgery was unacceptable. One of Ilene’s surgical nurses recommended LeClaire contact Khaw. Together, they came up with the idea to create a solution that could be injected into the cancerous tissue using the same imaging currently used to place the wire marker. The polymers are liquid at room temperature but turn to a gel at body temperature to create a marble-like marker in the breast, Khaw said.
LeClaire and Khaw pitched their idea to students in the biomedical engineering program at Texas A&M University. The students took on the project in August 2009 and spent the school year researching polymers that could be used.
“All of the sudden, the ball got rolling,” LeClaire said.
Proving the concept
LeClaire and Khaw, with help from the Spokane Intercollegiate Research and Technology Institute, developed a business plan, established Malignext Targeting Technologies and applied for a patent. The pair sold stock in the company to raise money to get the business off the ground.
Armed with the polymers identified by Texas A&M students, Khaw and LeClaire approached Washington State University researchers in Pullman, where the polymers were tested on pigs and rats.
“We proved the concept at WSU,” LeClaire said.
After that research was completed in the fall of 2011, LeClaire and Khaw turned to Pacific Northwest National Laboratory. Barbara Tarasevich, a research scientist at the lab, has spent the past few years further developing the polymers.
LeClaire and Khaw are now applying for grants to finish that work and, eventually, begin the lengthy process for Food and Drug Administration approval.
They’re among 10 finalists for a $250,000 grant through the state Life Sciences Discovery Fund, which invests money from the Master Tobacco Settlement Agreement in research and development across Washington. They should know this month whether they’re among the grant winners.
They need about $500,000 to finish their work at Pacific Northwest National Laboratory; it’ll take several million dollars to complete the FDA process.
Despite the climb ahead, LeClaire and Khaw are committed to bringing the technology to operating rooms.
“We know we have this technology that will work,” LeClaire said. “You can’t give up. You just can’t.”