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. 2024 Oct 22;8(1):120.
doi: 10.1186/s41747-024-00515-4.

Ultrasound-guided cryoablation of early breast cancer: safety, technical efficacy, patients' satisfaction, and outcome prediction with MRI/CEM: a pilot case-control study

Francesca Galati  1 , Marcella Pasculli  2 , Roberto Maroncelli  2 , Veronica Rizzo  2 , Giuliana Moffa  2 , Bruna Cerbelli  3 , Giulia d'Amati  2 , Carlo Catalano  2 , Federica Pediconi  2
Affiliations

Ultrasound-guided cryoablation of early breast cancer: safety, technical efficacy, patients' satisfaction, and outcome prediction with MRI/CEM: a pilot case-control study

Francesca Galati et al. Eur Radiol Exp. .

Abstract

Background: This pilot prospective study aimed to evaluate ultrasound-guided cryoablation of breast cancer (BC) by assessing: (i) technical efficacy as the presence of necrosis in surgical specimens and rate of complete tumor ablation; (ii) safety as incidence and severity of complications; and (iii) patients' satisfaction using a dedicated questionnaire. In addition, (iv) we tested the capability of magnetic resonance imaging (MRI) or contrast-enhanced mammography (CEM) to predict cryoablation efficacy.

Methods: From 07/2022 to 01/2023, we enrolled 20 patients with early-stage BC scheduled for breast surgery. Ten of them, with a cryo-feasible cancer location, were sent to cryoablation (cryo-group) and ten to routine surgical practice (control group). Both groups underwent surgery and were asked to answer a satisfaction questionnaire.

Results: Of eleven patients screened for cryoablation, only one refused to be treated at another hospital (acceptance rate 10/11, 91%). Surgery was quadrantectomy in 19 cases and mastectomy in 1. In the cryo-group, the procedure was completed and steatonecrosis was observed in 10/10 cases, with complete tumor ablation in nine of them. The post-procedural status was evaluated with MRI in five patients, with CEM in four patients, and with ultrasound in one patient who refused MRI and CEM. MRI or CEM correctly predicted complete cryoablation in eight patients and incomplete cryoablation in one patient. Patients in both groups did not have serious complications and responded positively to satisfaction questionnaires.

Conclusion: Ultrasound-guided cryoablation of early-stage BC is well accepted by patients, effective, and safe. MRI and CEM were able to predict the procedure's technical efficacy.

Trial registration: https://clinicaltrials.gov/study/NCT05727813 updated February 14, 2023.

Relevance statement: Our pilot study showed that ultrasound-guided cryoablation is a promising nonsurgical alternative for treating early-stage BC.

Key points: Ultrasound-guided cryoablation was effective and safe in early BC patients. The procedure was well-tolerated, with low morbidity and high patient satisfaction. MRI and CEM predicted cryoablation efficacy, in accordance with histopathologic findings. Cryoablation can be considered a potential alternative to surgery in selected patients.

Keywords: Breast neoplasms; Contrast-enhanced mammography; Cryosurgery; Magnetic resonance imaging; Patient satisfaction.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Ultrasound-guided cryoablation of 9-mm cancer in the outer upper quadrant of the left breast. a The transversal image represents the cryo-probe inside the core of the target lesion. b The transversal image demonstrates the “ice ball” formation, during the first cryoablation freeze cycle, which completely encompasses the tumor. c The image shows the reduction in size of the “ice ball” during the first thaw cycle
Fig. 2
Fig. 2
Ultrasound-guided cryoablation procedure questionnaire
Fig. 3
Fig. 3
CEM evaluation of cryoablation efficacy and technical success. Pre-cryoablation CEM MLO view of the right breast: a low-energy image shows a 14-mm mass with irregular shape and spiculated margins in the upper outer quadrant; b MLO and (c) CC recombined images show a corresponding mass enhancement; d post-cryoablation CC recombined image shows an area of inflammation surrounding the treated area and a 5 mm focus of contrast enhancement in the peripheral zone of the tumor bed (white arrow); and (e) the gross specimen shows a homogenous hemorrhagic area with a peripheral white portion (white arrow) that corresponds histologically to a residual component of invasive no special type carcinoma, estrogen receptor 98%, progesterone receptor 30%, human epidermal growth factor receptor 2 (HER2) 0, proliferation index (Ki-67) 24%
Fig. 4
Fig. 4
MRI assessment of cryoablation efficacy and technical success. a Pre-cryoablation MRI: axial contrast-enhancedT1-weighted subtracted image shows a 12-mm mass lesion with irregular margins in the upper outer quadrant of the left breast. b Post-cryoablation MRI: axial unenhanced T2-weighted fat-suppressed image shows minimal edematous imbibition at the site of cryoablation, consistent with post-procedural inflammation. c Axial contrast-enhanced T1-weighted subtracted image shows a peripheral inflammatory enhancement of the treated area. d The corresponding gross specimen shows a central brown hemorrhagic area surrounded by a yellow halo
Fig. 5
Fig. 5
CEM evaluation of cryoablation efficacy and technical success. Pre-cryoablation CEM MLO views of the left breast: a low-energy image shows a 16-mm mass with spiculated margins between the upper quadrants; b recombined image shows a corresponding mass enhancement. Post-cryoablation CEM MLO views of the left breast: c low-energy image shows an area of parenchymal distortion in the upper quadrants and (d) recombined image shows no enhancement at the site of the lesion treated with cryoablation
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