A Pilot Study of Ultrasound-Guided Cryoablation of Invasive Ductal Carcinomas up to 15 mm With MRI Follow-Up and Subsequent Surgical Resection

Abstract

OBJECTIVE The purpose of this study was to evaluate the effectiveness of ultrasound-guided cryoablation in treating small invasive ductal carcinoma and to assess the role of contrast-enhanced (CE) MRI in determining the outcome of cryoablation. SUBJECTS AND METHODS Twenty consecutive participants with invasive ductal carcinomas up to 15 mm, with limited or no ductal carcinoma in situ (DCIS), underwent ultrasound-guided cryoablation. Preablation mammography, ultrasound, and CE-MRI were performed to assess eligibility. Clinical status was evaluated at 1 day, 7–10 days, and 2 weeks after ablation. CE-MRI was performed 25–40 days after ablation, followed by surgical resection within 5 days. RESULTS Ultrasound-guided cryoablation was uniformly technically successful, and postablation clinical status was good to excellent in all participants. Cryoablation was not clinically successful in 15% (three of 20 patients). Three participants had residual cancer at the periphery of the cryoablation site. Two participants had viable nonmalignant tissue within the central zone of cryoablation-induced necrosis. Postablation CE-MRI had a sensitivity of 0% (0/3) and specificity of 88% (15/17). The predictive value of negative findings on CE-MRI was 83% (15/18). Correlations between cancer characteristics, cryoablation procedural variables, postablation CE-MRI findings, and surgical specimen features were not statistically significant. There were also no significant differences in participants with or without residual cancer. CONCLUSION In our pilot experience, ultrasound-guided cryoablation of invasive ductal carcinomas up to 15 mm has a clinical failure rate of 15% but is technically feasible and well tolerated by patients. The majority of cryoablation failures are manifest as DCIS outside the cryoablation field. Postablation CE-MRI does not reliably predict cryoablation outcome.

Fluorodeoxyglucose positron emission tomography/computed tomography findings after percutaneous cryoablation of early breast cancer

“…Cryoablation is widely accepted as the treatment for tumors in several organs (kidney, prostate, liver) [2][3][4]. Increasing numbers of studies have reported the feasibility and short-time outcomes of cryoablation of early breast cancer [5][6][7][8][9]. Additionally, two clinical phase-2 trials (NCT01992250, NCT02200705) to investigate complete response and local recurrence rates after cryoablation of early breast cancer are ongoing.…”

Cryo-Assisted Resection En Bloc, and Cryoablation In Situ, of Primary Breast Cancer Coupled With Intraoperative Ultrasound-Guided Tracer Injection: A Preliminary Clinical Study

“…The precise needle positioning at the deep part of the tumor and the subsequent injection of the dye before needle cooling could be adjusted for each case through IOUS. 38 This start freeze-and-inject drug delivery strategy, which prevents the tracer from penetrating the frozen tumor, distributes a smaller volume of dye intratumor compared to a start inject-and-freeze delivery sequence, which would distribute a grander dye volume into the unfrozen tumor before freezing. Previous study 36 has demonstrated that such cryo-assisted drug delivery strategy has no effect on the intra- or extratumoral dye distribution.…”

<p>Cryoablation In The Management Of Breast Cancer: Evidence To Date</p>

“…They concluded that cryoablation was technically feasible and well tolerated by patients, although a clinical failure rate of 15% was observed. Interestingly, the authors highlighted that technical failures occurred when DCIS component was outside the cryoablation field 31…”

“…Literature search reveals a high heterogeneity on this topic. Some studies enrolled a small number of patients at various stages of disease,18,33 in others surgical tumor removal was performed after cryoablation,31,34 and in others again percutaneous ablation was the only modality of treatment,6,35 thus reliable conclusions on the usefulness of cryoablation in the subgroup with early breast cancer could not be drawn.…”

“…In the Z1072 trial, the negative predictive value of MRI was 81.2% 32. Poplack et al, in their retrospective study, observed that MRI was not useful to predict cryoablation results accurately, such as the detection of residual cancer and the recognition of benign cryoablation-related change 31…”