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Cryoablation

Learn About RMI’s Participation in a Clinical Trial of Cryoablation for Early Stage Breast Cancer

About Cryoablation

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.

Invasive ductal carcinoma is the most common form of breast cancer. Although cryoablation is not yet in general clinical use for treating breast cancer, a past clinical trial has shown it effective in Stage I breast cancer patients with a single, small tumor that is solid, round, and distinct, and that has not spread to other areas.

About the Clinical Trial

Working with Genesys Regional Medical Center, the local lead organization for the trial, doctors from RMI and the Michigan Center for Surgical Specialists are helping the American College of Surgeons Oncology Group (ACOSOG) evaluate cryoablation as a possible standard treatment option for breast cancer.

Who Can Participate?

Patients diagnosed with Stage I invasive ductal breast carcinoma, with a single, distinct tumor 2 centimeters in diameter or less, may be eligible. Diagnosis will be verified by a needle biopsy at RMI. Patients must not be pregnant. Other restrictions, such as past history with certain types of biopsies, may exclude some patients. All criteria will be reviewed in detail with patients interested in participating.

Many candidates for the trial will be identified as early-stage breast cancer cases are diagnosed during routine breast imaging tests. But patients who believe they may be candidates can ask their doctors to contact Dr. Linsey Gold’s office at 810-606-7670.

Will Participating in the Trial Affect Patients’ Prognosis?

The cryoablation procedure will not adversely affect the positive prognosis of patients with Stage I invasive ductal breast carcinoma. After the cryoablation, participants will still receive a traditional lumpectomy, which is the current treatment of choice. For trial participants, cryoablation is not being used as a direct treatment method but rather as a pre-treatment test to determine whether the procedure is effective in destroying all cancer cells.

Standard followup treatments for lumpectomy patients will also be conducted. Depending on the individual patient’s case, this could include anti-hormone therapy and radiation therapy.

What Can Patients Expect During the Procedure?

Performed under local anesthesia, the cryoablation procedure is virtually painless and takes approximately 20 minutes in RMI’s outpatient facility on Lennon Road. A probe about the size of a pencil will be inserted into the middle of the tumor, guided by ultrasound. No hospital stay is necessary, and patients should be able to resume a normal routine almost immediately.

Patients will undergo 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. The followup MRI is related to another goal of the clinical trial: investigating whether an MRI is as effective as a pathological examination in verifying that the cancer has been destroyed. Participants will also have a blood sample drawn that will be used to test for evidence of an anti-cancer immune response after the cryoablation.

Are There Side Effects?

Participants may experience some side effects from the cryoablation procedure, and should discuss those possibilities with their medical team before finalizing their decision to participate.

Is There a Cost to Participate?

There is no cost to patients or their insurance plans to participate in the trial. Costs for the standard lumpectomy and other tests and treatments that patients would otherwise receive remain the responsibility of the patients or their insurance companies.

What are the Deadlines?

The study is an “open trial”—meaning that there is no set end date or limitation on the number of patients.