Updated Wednesday, Feb. 25, 2009.
CLEVELAND, Ohio — Imalux Corp. has discovered that its medical imaging technology could be used to quickly diagnose pre-cancer and cancer of the cervix — at low cost and without doing a biopsy.
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This discovery — through two clinical trials in China – is driving development of a second generation of the company’s Niris imaging technology that could enable doctors to diagnose and treat pre-cancers in one visit instead of three, said Dr. Nancy Tresser, vice president and chief medical officer at the Cleveland, Ohio, company.
That could lower the cost of health care and lead to more women being treated before they get full-blown cervical cancer, Dr. Tresser said. It also could make cervical cancer diagnosis the leading application for the emerging imaging modality Imalux has been working on for several years.
In the latest study, which has yet to be published, researchers found they could distinguish between three grades of pre-cancerous infections of the cervix and cervical cancer just by looking at Niris images, Tresser said. Typically, biopsies — microscopic analyses of tissue samples — are used to diagnose pre-cancers or cancer, she said.
Biopsy results take time. Most women must visit a doctor three times to be diagnosed and treated for a pre-cancerous cervical infection, Tresser said.
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But 70 percent of women diagnosed with pre-cancer — including those in developing countries – fail to return for treatment, which is highly successful at heading off cancer. “They just don’t get treated,” she said.
Once a woman has cervical cancer, hysterectomy — removal of the cervix and uterus — is the usual treatment, she said.
“Cervical cancer is the most common cause of death among young women around the world,” Tresser said. “It’s a huge population that we’re looking to help.”
The study by Imalux and Preventive Oncology International Inc. (POI) appears to be the first to distinguish between the grades of cervical pre-cancers with statistical significance, Tresser said. This distinction can guide treatment.
Niris also found 50 percent more cancer lesions than visual inspection of the cervix, she said.
“It’s so exciting for us,” said Tresser, who for years has directed research to find ways Niris could be used to diagnose and treat disease.
Niris uses near-infrared light to create real-time images of surface layers of tissue. The process is called optical coherence tomography, or  OCT, for short.
“Simply by touching the tissue with a little probe, the infrared light penetrates, gets reflected back and instantly creates an image on a screen that looks like a biopsy,” said Dr. Jerome Belinson, founder and president of POI.
“The technology is especially good for the first couple of millimeters of tissue thickness, and that’s where the most important changes of pre-cancerous abnormalities will occur on the cervix,” said Dr. Belinson, a gynecologic oncologist who led the Cleveland Clinic’s section in that practice for nearly a decade before retiring in 2008.
Belinson, a professor of surgery at the Clinic’s medical school, has done research in China for years to refine the ability of Niris to diagnose cervical pre-cancers. In the most recent study, he and his colleagues overlaid Niris images with computer algorithms. “As far as we know, it is the first imaging modality that can separate out all the pre-cancerous changes [from] cancer,” he said.
“It’s a big breakthrough in the sense that … it really does validate that this technology can work, and that we’re on the right track,” Belinson said.
Imalux and Preventive Oncology International, which Belinson “founded a dozen years ago to blend humanitarian care with clinical science,” have asked the National Institutes of Health for research money to refine Niris as a low-cost diagnostic technology. Tresser hopes to have the cervical cancer system ready for market by year’s end.
“Although this clearly has applications in the Clevelands of the world, my real goal is to be able to develop a very low-cost version of the technology that can allow people to go into under-served areas and … instantly make diagnoses that are accurate, and treat the development of cancers without having to do biopsies and at the point of care,” Belinson said.
