Williams, however, had a serious heart condition that prevented her from undergoing anesthesia. And her cardiologist cautioned her against receiving radiation or chemotherapy. In the past, this would have left Williams with no treatment options for her cancer.
Fortunately, Williams’ medical oncologist at Siteman Cancer Center was able to refer her to Heather V. Garrett, MD, associate professor of radiology in the breast imaging section at Mallinckrodt Institute of Radiology (MIR). Garrett was the first physician in St. Louis to perform a nonsurgical procedure called percutaneous ultrasound-guided breast cryoablation for patients like Williams, whose medical conditions or age prevent them from having surgery. With a particular interest in the procedure, Garrett has received training in breast cryoablation at Memorial Sloan Kettering Cancer Center in New York and at a master course offered by the Society of Interventional Oncology.
In August 2023, with Williams needing only a local anesthetic, Garrett used ultrasound to guide a needle-shaped cryoprobe into the tumor. An extremely cold gas pumped through the cryoprobe froze and destroyed the abnormal cells. Williams was awake throughout the procedure and went home the same day with no pain or side effects.
How Garrett became the area’s expert in breast cryoablation — and now the lead investigator on the first trial ever to compare outcomes for cryoablation and lumpectomy — began in 2022 with a conversation she had with Anurag Chahal, MD, then a second-year diagnostic radiology resident at MIR.
Is Ablation an Option?
Chahal had gained experience with cryoablation while completing a cardiopulmonary fellowship at the University of Alabama at Birmingham. “We performed successful cryoablations for lung cancer at UAB, and cryoablation is established for cancer treatment in other soft tissues and organs such as kidneys and liver,” Chahal said.
“Breast cryoablation has been around for probably 20 years, but it mainly is performed within academic settings,” Garrett said. “Breast surgery — lumpectomy in particular — and other breast cancer treatments are incredibly successful, and people do very well with them. Until recently, there hasn’t been a lot of drive to find alternatives,” she said. “However, we are now learning that we may be overtreating some breast cancers, so there is motivation to find less intensive treatments.”
As Garrett and Chahal began to conceptualize the trial, one point was clear: Their aim was not to prove the outcomes for breast cryoablation were superior to lumpectomy.
“Lumpectomy is a highly successful treatment for early-stage breast cancer; cryoablation is not going to surpass it. What we wanted to show is that breast cryoablation is not inferior to lumpectomy,” Garrett said.
Before proceeding, they presented their idea for a noninferiority trial to Julie Margenthaler, MD, professor of surgery at Washington University School of Medicine. She gave her full support.
“We are now learning that we may be overtreating some breast cancers, so there is motivation to find less intensive treatments.”
“There is a growing body of data demonstrating excellent outcomes with cryoablation. However, in order to directly compare this to the gold standard of surgery, a randomized clinical trial is critical,” said Margenthaler, director of breast surgical services at Siteman. “Dr. Garrett and our MIR team are already skilled at percutaneous procedures. This is a natural extension of their expertise. In addition, Dr. Garrett has been studying the basic science behind cryoablation and has become an expert in its potential benefits.”
Robert C. McKinstry, MD, PhD, senior vice chair and division director, diagnostic imaging at MIR, also was enthusiastic about the study. “We always want to do the most minimally invasive approach that optimizes patients’ outcomes and experiences,” said McKinstry, the William R. Orthwein Jr. and Laura Rand Orthwein Professor of Radiology and Pediatrics. “Gathering the evidence to support the viability of breast cryoablation is an important step in expanding our options for treatment.”
That last sentence expressed an ongoing concern of Garrett’s. It was clear that for certain patients, breast cryoablation offered advantages over lumpectomy: No anesthesia is needed. There is little or no recovery time, nor is there discomfort following the procedure. Patients need not wait four weeks for surgical scars to heal to begin or resume chemotherapy or radiation. And cosmetically, there are no scars or loss of breast volume.
“We always want to do the most minimally invasive approach that optimizes patients’ outcomes and experiences.”
Proof did not exist, however, that outcomes for breast cryoablation were comparable to those achieved with lumpectomy. Without that evidence, the procedure was not covered by the Centers for Medicare and Medicaid Services and by only a few private insurers, a factor in its relatively limited availability. Garrett and Chahal decided to answer the question.
With those endorsements, Garrett began accessing the resources available to develop a clinical trial. Funding was secured from both MIR and the School of Medicine as well as the Barnes-Jewish Hospital Foundation and an industry vendor. Support in developing the trial’s protocols was provided by Siteman’s protocol development team and MIR’s Clinical Research Core, which assists in the training, design, execution and analysis of basic and translational science.
COOL IT
Two years in the making, the result of Garrett and Chahal’s vision is the COOL IT Trial: Cryoablation Compared to Lumpectomy for the Treatment of Patients with T1 Breast Cancer. As a randomized, controlled “do no harm” trial, it is enrolling healthy patients with small, low-risk, low-grade breast cancers who will be randomly selected to receive treatment with either cryoablation or lumpectomy.
“Our primary endpoint is comparing the five-year breast tumor recurrence rate for the two procedures,” Garrett said. “Statistics show that in five years, less than 5% of lumpectomy patients have a local recurrence of their cancer. Our aim is to determine whether breast cryoablation has comparable results.”
In addition, she is leading a multisite study called COOL-IT-PRO, Cryoablation of Breast Cancer in Nonsurgical Patients, a subject registry study of patients who undergo cryoablation for their breast cancer after being determined not to be surgical candidates. “Data collected as part of this registry will be used to assess the safety of percutaneous ultrasound-guided cryoablation in this population, as well as provide long-term follow-up of subjects who received cryoablation,” Garrett said.
McKinstry sees the development of the COOL IT trial as a “meeting of the minds” between two radiology cultures. “Dr. Chahal as an interventional-minded radiologist and Dr. Garrett as a breast-imaging specialist found a common cause in their desire to provide exceptional care to patients,” he said. “Their determination to prove the potential that exists for breast cryoablation is admirable.”
For Irma Williams, now 79, who thought her cancer was untreatable, breast cryoablation was literally an answer to a lot of prayers.
“I have three children, seven grandchildren and 12 great-grandkids, and they were all praying for a positive outcome. Dr. Garrett gave me that,” she said. “All these kids — no matter what their age — are a lot of fun. I don’t want to miss a thing in their lives.”
Published in Focal Spot Fall 2024 Issue