Cryoablation is a medical procedure that we may soon be hearing much more about, with its potential to reshape and improve the approach to treating the most common form of early stage breast cancer.

And with two Michigan physicians serving as investigators in an important new clinical trial, area patients have an opportunity to contribute to that future while still receiving the current treatment of choice.

Part of a medical subspecialty called interventional radiology, cryoablation literally freezes tumors to death with argon gas, delivered through small, ultrasound-guided probes. One of the most promising applications is for invasive ductal carcinoma--in lay terms, a solid, distinct, malignant breast tumor in the lining of a milk duct.

Doctors from two Mid-Michigan practices, Regional Medical Imaging (RMI) in Flint and the Michigan Center for Surgical Specialists in Grand Blanc, are helping the American College of Surgeons Oncology Group (ACOSOG) evaluate cryoablation as a possible standard treatment option for breast cancer.

Currently, the treatment of choice for early stage breast cancer is a lumpectomy--surgical removal of the tumor and enough surrounding tissue to achieve a "clean edge" free of cancer cells.

But in 2003, a report on an initial trial led by the University of Michigan Comprehensive Cancer Center found cryoablation 100 percent effective for tumors as large as 1.5 cm in diameter with no cancer spread to surrounding tissues.

Now, ACOSOG is investigating the next level, with tumors as large as 2 cm. Locally, the lead organization for the trial is Genesys Regional Medical Center. Linsey P. Gold, DO, MD, a surgical oncologist with the Michigan Center for Surgical Specialists, and Randy Hicks, MD, of RMI, will be qualifying patients and conducting cryoablation procedures at RMI's Lennon Road office.

Patients will undergo cryoablation and a followup MRI two weeks later, followed by a traditional lumpectomy. Pathologists will then examine surgically removed tissue to determine whether cryoablation successfully destroyed all cancer cells.

Another goal of the study will be to evaluate whether MRI equals the effectiveness of a tissue examination by pathologists in assessing the success of cryoablation.

Dr. Gold stressed that the trial will not negatively affect participants' positive prognosis as early stage breast cancer patients, since they will still receive the current treatment of choice.

"They'll still have a lumpectomy followed by radiation and anti-hormone therapy, as they would have otherwise," she says. "I'm telling patients that 'Cryoablation won't make a direct difference in your cancer, but it might make a better treatment available to your daughter or granddaughter, the same way past patients have helped you.'"

According to Dr. Hicks, cryoablation could significantly improve the quality of life of breast cancer patients if it proves equal to traditional lumpectomy in effectiveness.

"Like all interventional radiology procedures we perform here at RMI, cryoablation is less invasive than traditional surgery," he says. "It's virtually painless, and takes about 20 minutes in our outpatient center on Lennon Road. Recovery time is minimal, with no hospital stay. Hopefully, cryoablation followed by an MRI will eventually make traditional surgery for this type of breast cancer unnecessary. It could be yet another success story of advanced, image-guided medical technology making treatment not only more effective, but also a lot easier on the patient."

Trial participants must have Stage I invasive ductal carcinoma, with a small, round tumor no more than 2 centimeters in diameter and no cancer cells spread elsewhere. Patients may not be pregnant. Other restrictions, such as past history with certain types of biopsies, may exclude some patients. Dr. Hicks will verify diagnosis through an MRI and needle biopsy.

There is no cost to patients or their insurance plans. The study is an "open trial"--meaning that there is no set end date or limitation on the number of patients. Most candidates will probably be identified in the course of routine referrals to RMI for annual mammograms or follow-up MRIs. But patients who believe they may be candidates may ask their primary care physician to contact Dr. Gold's office at 810-606-7670.