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April 26, 2004

A New Ice Age
By Amy L. Conver
Vol. 5 No. 9 p. 20

Until recently, women with fibroadenomas (the most common type of benign breast tumors) had few treatment options. They could live with the sometimes painful lumps or undergo surgery and hope for a good cosmetic outcome and no recurrence. Now, women unwilling or unable to tolerate these courses can choose a really “cool” new option: office-based, ultrasound-guided cryoablation.

Jennifer Veenhof, age 22, says she first heard about cryoablation when she went to a breast center for a biopsy evaluation. Eager to have yet another painful breast fibroadenoma removed, she chose cryotherapy over surgery because she didn’t want to deal with a lengthy recovery.

Radiologist Gary Levine, MD, cryoablated Veenhof’s tumor at West Coast Breast Center in Irvine, Calif., with the help of a technologist.

Veenhof, who had surgery on her left breast last year to remove a similar fibroadenoma, says she was in and out of the office in less than one hour and is “ecstatic with the cryotherapy results.”

“There’s no competition. I would take cryoablation over anything else. It was wonderful. No side effects, no recovery time. It was pretty much painless,” she says. “Here it is less than 48 hours after the procedure, and I’m up and moving and working and even painting my room.” Veenhof notes that she could barely move after last year’s surgery and that it took almost a month and a half before she was back to her regular routine.

Aside from localized bruising and tenderness, she says the only other sign that she had a procedure done is a tiny needle hole on her breast covered by a small bandage. She says the most uncomfortable part of the procedure was keeping her arm above her head and out of the way.

To keep Veenhof’s skin from freezing, Levine injected a protective saline layer above the tumor. Superficial fibroadenomas require diligent attention to skin protection and, according to Levine, can be one contraindication to cryoablation. He says the extremely low temperatures involved in the procedure are to blame. “You are freezing at very low temperatures, sometimes -160°. If the fibroadenoma is intimately related to the skin, the skin itself can freeze and damage can occur.”

Levine, the principal investigator of a multicenter clinical trial for breast radiologists, says he will evaluate Veenhof’s cryoablated tumor one month, three months, six months, and one year after the procedure. He notes that this frequency is necessary to obtain measurements for the trial and is not standard practice.

Veenhof says Levine warned her that her tumor will feel larger for approximately one month until swelling subsides. However, she says this side effect pales in comparison to her previous surgery’s aftereffects.

“Shrinking” Away from Surgery
Similar cryoablative techniques are being used by both radiologists and surgeons at multiple sites around the country to shrink breast fibroadenomas. A recent study, headed by radiologist Peter J. Littrup, MD, confirmed the technique’s effectiveness in shrinking these fibroadenomas, which affect 10% of American women (most in their late teens and early 20s, although African American women have twice the incidence rate).

Littrup, a professor of radiology, urology, and radiation oncology at Wayne State University and the director of the image-guided therapy program at Karmanos Cancer Institute in Detroit, announced the study results at RSNA 2003. Coauthors included Laurie Freeman-Gibbs, MS, RN; Michael White, MD; Kathy Carolin, MD; Ted Harb, MD; and Amit Vyas, MD.

Littrup said fibroadenomas are generally considered “leave-alone lesions.” Cryoablation is important because these lesions are usually surgically removed if they are larger than 2 centimeters or keep growing.

Physicians perform more than 1 million benign surgical biopsies in the United States each year. Littrup said such surgeries can damage breast tissue and leave scars on the surface of the breast. Conversely, he said the cryoablative procedure, which was approved by the FDA in 2001, is a virtually painless way to significantly reduce benign breast lumps up to 4 centimeters in diameter while preserving breast structure.

The technique works as follows: A physician injects local anesthesia into breast tissue around the mass and uses ultrasound to guide a cryoprobe smaller than a match head through a 3-millimeter incision and into the fibroadenoma. An ice ball forms at the tip of the cryoprobe and continues to grow until ultrasound confirms that the fibroadenoma is encompassed. A freeze-thaw-freeze regimen ensures cellular destruction (which occurs when temperatures reach the -20° to -40° range) in the fibroadenoma’s outer edges. Treatment cycles range from six to 30 minutes, depending on the tumor’s size. A thermocouple (thermometer) confirms cytotoxicity occurrence. Saline injections between the skin and the tumor are sometimes necessary to protect the skin from the extreme cold. Littrup said physical intervention is also sometimes necessary to prevent the ice ball from entering the chest wall. “You can actually pick up the ice ball as it forms and gently move it around. That protects the underlying skin,” he said.

The entire procedure takes approximately 30 to 45 minutes and requires no sutures. The patient leaves with the frozen tumor still in her body. She can usually drive home after the procedure, and most patients have reported no residual pain. Over the next six months to one year, the tissue returns to normal, reducing the fibroadenoma by as much as 75%.

Littrup and his colleagues used this technique to treat 42 fibroadenomas originally planned for surgical removal in 27 patients. No study participant’s fibroadenoma was greater than 4 centimeters in diameter and, on average, the tumors shrank by 73%. Littrup reported that 80% of the women treated during the study could no longer feel the tumor at six months. He said ultrasound can quantify volume reduction and that one year post-treatment, tumors have usually shrunk so much that only internal scarring remains. Littrup reported that no significant complications were noted during the study and patients were pleased with the cosmetic results.

The Cosmetic Difference
Cryoablation’s conservative effect on the breast—both internally and externally—was closely evaluated during the study. “Cryoablation is important because it has the opportunity to remove significant surgical scarring that is an issue particularly for younger women and African American women,” Littrup said. “The bottom line is that women keep getting these fibroadenomas, which can be quite disfiguring. Cryoablation preserves the architecture of the tissue, which is composed of collagen. It really doesn’t melt it like heat-based treatments do, so everything remains pretty much intact and the healing produces minimal scarring.

“Probably the most stunning example of this [preservative effect] was seen in a 15-year-old girl who came to us. She had four previous resections and had keloids, or bad scars, in her breast. Doctors were actually contemplating doing bilateral mastectomy—removing both breasts—because they knew she was going to end up filled with scars. Over a one-year period, we froze seven of her tumors in five treatment sessions. These tumors regressed so significantly that there were virtually no scars, no palpable mass, and we saved both breasts in a young woman.”

The study, which was part of a broader FDA trial assessing the long-term cosmetic and imaging outcomes of cryotherapy, received a grant from Sanarus Medical, Inc., suppliers of the Visica cryoablation system used in the study.

Scott Tremberth, of Sanarus, says the company—which officially launched Visica in June 2003—is working with leading breast surgeons and breast radiologists on the FACT (FibroAdenoma CryoTherapy) registry, a formal, postmarket clinical gathering of data. Headed by Michael Edwards, MD, past president of the American Society of Breast Surgeons and current chairman of the department of surgery at the University of Arkansas Medical School, the registry involves 75 sites across the country. Tremberth says these sites are now collecting six-week, six-month, and one-year data on patients who received cryoablation of their fibroadenomas with the Visica system. To date, he says that number includes more than 500 patients. He also notes that some sites are monitoring patients about to pass the two-year postprocedure mark.

Minimally Invasive Advances
Tremberth says Sanarus is also setting up a multicenter clinical trial for breast radiologists. He says that the advent of minimally invasive technologies has paved the way for radiologists’ involvement in the treatment of fibroadenomas. “To date, a surgeon’s really been the only alternative. However, most surgeons don’t like going to the operating room [OR] for benign disease. Minimally invasive approaches are changing that. For example, breast biopsies used to be done in the OR by surgeons. Today, 300,000 to 400,000 of these biopsies are done by radiologists each year.”

Levine agrees that breast radiologists are a natural choice to perform cryotherapy. “There’s not much training that a breast radiologist needs to do. It’s a very simple image-guided procedure,” says Levine, medical director at West Coast Breast Center and associate clinical professor at UCI Medical Center.

“When we can, we like to not only diagnose percutaneously, but treat percutaneously. In this case, the technology is available for us to ablate benign lesions using cryotherapy. The patient is able to avoid both the expense and the morbidity associated with surgery. This is great technology, and I think it’s the future of where breast care is going.”

Cryotherapy for Cancer?
While cryotherapy itself seems like a futuristic procedure, doctors are already speculating on its next applications and technology offshoots. “Many companies are working on technologies to treat both benign and malignant breast disease percutaneously,” says Levine. “People are looking at laser ablation, radiofrequency ablation, as well as cryoablation. Those seem to be the three prongs right now. I think all of these technologies will eventually be tested in a malignant setting to see if surgery can be avoided. But long-term clinical trials need to be done to prove that it’s safe and efficacious.”

At RSNA, Littrup noted that he has treated two breast cancers with cryoablation. Based on the results of his study, radiologists at the Karmanos Cancer Institute have begun using cryotherapy to treat other organ sites, primarily using CT guidance, which easily visualizes the ice. Tremberth emphasizes that cryoablation for breast malignancies is still investigational and that the Visica cryoablation system is currently designed for benign disease ablation as an alternative to surgery or no treatment.

“We know we can kill cells, but we don’t know for sure if we can put our cryoablation system in everybody’s hands and have the right cells killed. That’s the issue,” says Tremberth.

Cost Considerations
Levine notes that while there is currently no CPT (Current Procedural Terminology) code for cryoablation of breast fibroadenomas, many insurers are allowing for reimbursement on a case-by-case basis as an alternative to surgery. The procedure costs approximately $3,000 compared with $5,000 to $8,000 for surgery.

“It’s not just considered cosmetic surgery,” notes Tremberth. “It is treatment of benign disease.”

Littrup said he believes cryoablation is a cost-effective solution for breast fibroadenomas. He then went a step further: “The final overall conclusion is that we can now transcend into other areas of the body as well as consider cryoablation for breast cancer.”

— Amy L. Conver is the assistant editor of Radiology Today.

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