Start-up promotes thermal imaging as way to judge cancer drug efficacy

Thermal imaging is a great idea that was tried too soon. Attempts in the ’60s to diagnose disease by recording “hot spots” in the body looked good in Life magazine but failed in real life. The technology lacked the sensitivity, resolution, and acquisition speed needed for medical applications.

The Strategic Defense Initiative of 1983 changed that. SDI led engineers to develop the quantum well infrared photodetector (QWIP) to pick out the heat signatures of nuclear-tipped missiles. When trained on the human body, this technology can document temperature differences of less than 0.0009°C (compared with about 1°C for ’60s thermal systems), capture data at 200 frames per second, and render 14-bit digital images. Earlier machines captured one frame per minute and created analog TV images.

OmniCorder Technologies of Stony Brook, NY, has licensed QWIP for use in its BioScan system. The thermal imaging and analysis product is designed specifically to evaluate cancer patients. The QWIP detector routes thermal data into a Windows-based dual Pentium III 750-MHz computer, which crunches data into images and calculations that indicate the location and character of cancer.

The camera, along with other components, is mounted on a compact mobile platform. A counter-balanced control arm permits camera adjustments. Images are displayed on a liquid crystal display monitor or color printer.

“What we represent is not just a new technology or a new company. We represent a new industry and a new way of doing things,” said Mark A. Fauci, founder, president, and CEO of OmniCorder. “We are doing what hasn’t been done before.”

Earlier thermal-based systems were positioned as diagnostic aids. BioScan is being groomed as an adjunct to therapy, delivering feedback on the effectiveness of drugs. Several customers have integrated the product into clinical studies of prospective new weapons against cancer. Fauci hopes that the use of BioScan in the clinical development of new drugs will lead naturally to its widespread adoption as the preferred means for monitoring patient response to therapy, once the drugs have been approved for use in the general population.

“As a research tool, BioScan can help in the drug discovery process and demonstrate that certain drugs do in fact work in a certain type of patient,” he said. “Out in the clinical environment, it can be used to monitor what will eventually become lifetime disease management, if these drugs are going to fulfill their promise.”

This new business model reflects how physicians are changing the way they look at cancer. New treatments are being designed less as cures and more as the means for managing cancer. Research teams are mixing therapeutic cocktails composed of an initial stage of radiotherapy, for example, followed by one or several drugs that will keep the remaining tumor under control. The hope is to transform the myriad types of cancer from acute, fatal diseases to chronic ones that can be held in check indefinitely.

Gleevec is among the new generation of promising drugs. In clinical trials reported at the annual meeting of the American Society of Clinical Oncology, the drug showed positive results against gastrointestinal sarcoma. BioScan documented some of the drug’s subclinical effects and may, in the future, help physicians better understand how drugs like Gleevec work.

“We hope to get an idea of minute differences in how the blood vessels that are feeding tumors may be changing-critical changes that play into the research base of antiangiogenesis strategies,” said Dr. George D. Demetri, principal investigator in the Gleevec trials and an assistant professor of medicine at Brigham and Women’s Hospital in Boston.

As BioScan records the presence of heat in varying amounts, algorithms built into the scanner analyze changing heat patterns. Research has documented that cancer cells release chemicals to stimulate the growth of blood vessels to feed the tumor. These stimulants also cause existing blood vessels to expand and contract, creating an oscillating heat pattern characteristic of growing cancer. Drugs effective against cancer change this heat pattern in a way that can be recorded with BioScan.

“Working with new regimens is what led us to these studies,” Fauci said. “With BioScan, we can say the patient is responding or, if the patient is not responding, the therapy can be reformulated for that particular patient until there is a response.”

Most medical technologies have limitations, and BioScan is no exception. The resolving power of the device decreases with the increasing depth of tumors in the body. Because BioScan is not intended as a stand-alone diagnostic tool, however, this limitation does not present a major problem, according to Fauci. Diagnostic mammography, MRI, or CT will have already determined the area to be surveyed thermally, and patients with metastases may offer several areas to monitor, some of which may be close to the body’s surface.

At present, only three clinical sites have access to BioScan, even though the device was cleared by the FDA more than 18 months ago. Sales have been lackluster mostly because the company has not been trying all that hard-and for good reason. BioScan’s niche, as a means for assessing the effectiveness of cancer therapy, cannot be filled until physicians have therapies that are effective against cancer. The coming wave of cancer-fighting drugs may present such an opportunity, and OmniCorder is maneuvering BioScan into position to ride that wave.

The Gleevec trial provided the first dramatic results to indicate the potential of BioScan, and other testimonials may be in the offing. Dr. Milos Janicek, an assistant professor of radiology at Brigham and Women’s, is leading a preliminary study comparing dynamic infrared imaging (DIRI) with PET and CT. Early results indicate that DIRI correlates well with conventional imaging in gauging tumor response to chemotherapy.

Such positive results play into the company’s bid to persuade pharmaceutical companies to use BioScan as the means for monitoring patient response to experimental drugs. Those efforts may develop into alliances between OmniCorder and drug companies to bundle BioScan with their products after they gain FDA approval, Fauci said.

The current situation is reminiscent of the days preceding the popularization of bone densitometers. These products languished for years in the U.S. until the commercial release of drugs designed to treat bone loss due to osteoporosis.

“It is a yin and yang kind of thing,” Fauci said. “What is the point of finding something unless you have some way of treating it?”

OmniCorder hopes to achieve the same kind of meteoric success as bone densitometry vendors.