Use of Transcutaneous and Percutaneous Ablation for the Treatment of Benign and Malignant Tumors of the Breast

Recommendations

• 1

  Indications for cryoablation or percutaneous excision of a fibroadenoma: a. The lesion must be easily visualized on ultrasound. b. The diagnosis of fibroadenoma must be confirmed histologically on core biopsy prior to treatment. c. The diagnosis of fibroadenoma must be concordant with the imaging findings, patient history, and physical exam. d. Lesions should be less than 4 cm in largest diameter. e. For cryoablation, caution must be taken to avoid thermal injury if the lesion is close (≤5mm) to skin or chest wall. Saline hydrodisplacement and/or warm packs may be used to protect from hypothermic injury to surrounding structures. f. This procedure may be performed by physicians with considerable ultrasound experience through extensive clinical exposure or credentialed courses, as precise needle placement is key to technical success.

  Treatment indication
• 2

  Indications for focused ultrasound ablation (FUA) for the treatment of fibroadenoma: FUA for the treatment of fibroadenoma is currently under investigation in the United States and is not approved by the FDA for this indication. This technique is considered investigational and should not be performed outside the realm of a clinical trial. There is an ongoing FDA-approved clinical trial for FFUA in the treatment of fibroadenomas.

  Treatment indication
• 3

  Indications for cryoablation of malignant tumors of the breast: a. The lesion must be easily visualized on ultrasound. b. Patients ≥70 years old. c. The malignant mass should be ≤1.5cm in size. d. On core needle biopsy, histologic diagnosis must be an invasive ductal carcinoma that is biologically low-risk, defined as grade 1-2, estrogen receptor and/or progesterone receptor positive and HER2 negative, Ki67 <15% and/or with genomic testing indicative of low-risk breast cancer. e. Ultrasound of the axilla should be performed to confirm clinically node-negative status. f. Contraindications to cryoablation include patients with lobular carcinoma, extensive intraductal component (defined as core biopsy specimen containing 25% or more of intraductal neoplasia), multifocal and or/multicentric disease, the presence of multifocal calcifications on mammogram, evidence of lymphovascular invasion, prior surgical biopsy for diagnosis or treatment of the index lesion, known coagulopathy or thrombocytopenia and those received neoadjuvant therapy. g. This procedure may be performed by a radiologist or a surgeon with considerable ultrasound experience through extensive clinical exposure or credentialed courses, as precise needle placement is key to technical success. Caution must be taken to avoid thermal injury if the lesion is close (≤5mm) to skin or chest wall. Saline hydrodisplacement and/or warm packs may be used to protect from hypothermic injury to surrounding structures.

  Treatment indication

Therapeutic Area

Guideline Scope

Inclusion Criteria

• Lesion easily visualized on ultrasound
• Diagnosis confirmed histologically on core biopsy prior to treatment
• Lesions less than 4 cm in largest diameter (for fibroadenoma)
• Patients >= 70 years old (for malignant tumors)
• Malignant mass <= 1.5cm in size
• Biologically low-risk invasive ductal carcinoma (grade 1-2, ER/PR positive, HER2 negative, Ki67 < 15%)
• Clinically node-negative status confirmed by axillary ultrasound

Exclusion Criteria

• Lobular carcinoma
• Extensive intraductal component (>= 25% of intraductal neoplasia)
• Multifocal and/or multicentric disease
• Presence of multifocal calcifications on mammogram
• Evidence of lymphovascular invasion
• Prior surgical biopsy for diagnosis or treatment of the index lesion
• Known coagulopathy or thrombocytopenia
• Received neoadjuvant therapy

Care Settings

Special Populations