Battling Breast Cancer

There's a deadly enemy stalking women. No bullets or missiles can be launched against this foe. No tanks or bombers can stop it.

The enemy is breast cancer and each day more than 100 women across the Nation die because of it. Thousands more suffer through painful sur-geries--in which part or all of the breast is removed--to rid the body of this devastating disease.

There is some good news for women, though. New technologies are making great strides in detecting and treating breast cancer. Surprisingly, many of these technologies were originally developed for the Ballistic Missile Defense Organization (BMDO). While ballistic missile defense does not engage in research aimed directly at medical problems, the technologies involved are frequently similar to those needed by doctors to defeat breast cancer.

In the following paragraphs, you will read about three BMDO technologies that have already joined or will soon be joining the battle against breast cancer. The first technology will raise the mark for early breast cancer detection, while the second technology significantly improves the elimination of the disease. A third technology is designed for damage control; that is, it increases the accuracy of breast reconstruction surgery, which helps reduce the psychological stress and cosmetic concerns associated with breast removal.

Catching cancers
Early detection is one of the keys to surviving breast cancer. Mammography, an x-ray of the breast, is the most common tool for finding breast tumors. But by the time a cancerous tumor has been found in a mammogram, it has already been growing for three to five years--sometimes longer.

OmniCorder Technologies, Inc. (Stony Brook, NY), is helping to catch tumors earlier with infrared detector technology funded by BMDO for space-based missile detection. The technology's infrared wavelength is ideal for the job because it detects subtle changes in breast temperature that indicate potentially cancerous masses.

"We use quantum well infrared photodetectors sensitive to temperature changes of less than 0.015 degree Celsius," said Mark Fauci, president and CEO of OmniCorder. "Breast cancer may escape detection from human eyes but not our infrared ones."

The photodetectors are incorporated in the company's BioScan System™, which was recently cleared by the FDA for sale as an adjunctive diagnostic screening technology for detecting breast cancer. For a scan, the patient sits in a chair while the camera device, coming to within 25 in. of the patient, records infrared light that is emitted from the breast; the data collected are then analyzed by special software. The camera and software together create a product 100 times more sensitive and 100 times faster than earlier devices.

In a recent study, BioScan was used to differentiate between malignant and benign masses. OmniCorder believes the system will discover false positives or confirm mammogram results and thus reduce the number of biopsies, 80 percent of which are negative. The company is also testing the device to determine if it can detect breast cancers that mammograms miss.
"Our vision is for the BioScan to become widely available in hospitals, clinics, and doctors' offices as a dominant means of early breast cancer detection," said Fauci. Instead of selling BioScan devices, OmniCorder plans to install them at licensed sites and charge a fee for each use. "Rather than sell a few thousand boxes, we hope to sell millions of service transactions," added Fauci. BioScan's footprint requires about the same amount of space as an ultrasound machine.
Although OmniCorder is working with several large medical device and pharmaceutical companies to commercialize its technology, the company is interested in finding a venture capital partner to help with production scale-up.

The company is also testing BioScan in therapeutic imaging and surgical applications. Researchers at Dana-Farber Cancer Institute in Boston are evaluating the system for monitoring cancer treatment and for detecting therapy-induced changes in various forms of cancer. Evaluation results were presented at the American Society of Clinical Oncology meeting in May 2001.
In addition, surgeons at the Mayo Clinic in Minneapolis are testing BioScan during brain surgery where the system is helping to identify and track malignant lesions as well as key brain functions.

Targeting tumors
Surgery isn't the most pleasant of experiences. But for many breast cancer patients, it's the only choice for treating the disease.

Celsion Corporation (Columbia, MD) has developed a new system that promises to reduce and, in some cases, eliminate the need for breast cancer surgery. The system capitalizes on missile surveillance technology funded by the Strategic Defense Initiative Organization, now BMDO.
Adaptive phased array (APA) technology was originally intended to target microwave energy on an enemy missile while simultaneously nullifying enemy jammers. But Celsion has applied this technology to breast cancer treatment, focusing microwave heat on tumors while nullifying the microwaves that would otherwise heat a patient's skin or healthy tissue.

"The first generation of microwave machines were likely to burn patients with deep-seated tumors without eradicating their cancers," said John Mon, Celsion's vice president of new business development. "Using APA technology, our system can aim microwaves so they reach peak intensity in a tumor, rather than in surrounding healthy tissue. It's a big advance in safety."
Celsion's system may be FDA approved for sale as a breast cancer treatment tool as early as 2002. During treatment, the patient lies prone on a table similar to that used in breast biopsies. The patient receives a single 20- to 40-minute microwave treatment during which the breast tumor is heated to about 115°F--hot enough to heat and kill cells containing high amounts of water. Breast cancer cells are about 80 percent water while healthy cells in breast tissue contain only about 20- to 60- percent water.

"In the first tests of the system, we learned that small and large tumors cannot be treated the same way," said Mon. "Therefore, we have developed two different protocols for using our technology to optimize the treatment for breast cancer patients."

When a patient has a small tumor and is scheduled for a lumpectomy, Celsion's system can be used alone to completely destroy the cancerous tissue, making the surgery safer and reducing the size of the lumpectomy procedure. This would allow surgeons to remove a small, dead tumor instead of a live tumor as is done in current lumpectomies.

For patients with medium to large tumors and who are scheduled for a mastectomy, Celsion's system can be used along with chemotherapy to shrink the tumors sufficiently, allowing breast-conserving lumpectomies to be performed instead of complete mastectomies. Alone, chemotherapy is only 20- to 30-percent effective in shrinking this size of tumor. Combined with Celsion's system, tumor shrinking becomes significantly more effective.

Like OmniCorder, Celsion intends to license its breast cancer treatment systems and then bill the licensee per service. It is also looking for new investors to help the company complete the FDA trials and ramp up for commercial production.

Other medical applications for Celsion's focused-heat technology abound. The company is looking into temperature-sensitive, drug-laden liposomes, which will work with its focused heat systems to target prostate, liver, ovarian, and other cancers. It is also developing heat-activated gene therapy treatments to keep tumors from repairing themselves after radiation and chemotherapy.

Reconstructing breasts
Reconstructing a breast after surgery can be a tricky job for surgeons. The goal, of course, is to make the new breast as natural-looking as possible, and to match the size and shape of the other breast. However, flat, two-dimensional photographs don't convey the volume or the true shape of the breast.

Genex Technology, Inc. (Kensington, MD), has developed a 3-D camera that allows breast surgeons to calculate that volume. "With this camera, we can create an accurate picture of the breast and generate objective three-dimensional data," said Greg Galdino, a resident surgeon at Johns Hopkins University's Division of Plastic and Reconstructive Surgery. "These data are quite useful to the surgeon in determining the volume of tissue or implant needed for the reconstructed breast."

The Rainbow 3-D Camera™ was originally developed for BMDO to track enemy missiles in space. By emitting a cascade of colored lights and measuring their reflection in wavelengths from various objects, the device calculates the distance to each object. It captures 300,000 such measurement points in each frame at a speed of 30 frames per second, equivalent to the speed of video. With real-time 3-D imaging data, BMDO can view missile trajectories on 3-D displays, or surgeons can see and measure the breast more accurately.

Twenty-five patients undergoing breast reconstruction or augmentation surgery at the hospital have already been scanned by the camera. Before each surgery, the device was used to determine the amount of volume needed to make the new breast symmetrical with the volume of the implant used. The result of the study showed that the camera provided a reliable guide for determining breast symmetry, volume, and shape prior to mastectomy, and for determining distribution of implant volume after augmentation.

Galdino said the goal is to develop a camera system that enables computer models to project what the finished breast will look like. Ideally, this system would be used when consulting with a patient pre-operatively. "After the camera captures the image, we'll be able to alter that image to the patient's liking or satisfaction," added Galdino. "That's always been the big dilemma in communication between the surgeon and patient."

In addition to breast reconstruction, the camera has other medical and non-medical applications. According to Genex Technology, the device is now part of a computerized tool that helps dentists accurately design prostheses, including crowns, bridges, and dentures. It also has been incorporated in a rapid prototyping system that builds complex shapes from 3-D models.

Winning battles
Over the years, great strides have been made in diagnosing and treating breast cancer. Of course, these gains didn't happen by accident. New technology helped pave the way, giving doctors advanced tools to push forward the boundaries of science and medicine.

Now, BMDO technology is at the forefront of the battle, beefing up the cancer-fighting arsenal. It's detecting cancers far earlier than mammograms. It's getting rid of cancerous tumors more effectively. And it's helping doctors reconstruct breasts more accurately. As more BMDO technology ends up in doctors' hands, one can only hope that more battles will be fought and won, and that the war on breast cancer will be that much closer to ending, forever.