Efficacy of MR-HIFU Ablation of Breast Cancer

Exclusion Criteria

• •Prior treatment with: neo-adjuvant systemic therapy in the past 3 months or radiotherapy or thermal therapy or surgery of any kind in the targeted breast.
• •Contraindications to MR imaging according to the hospital guidelines (e.g. pacemaker in situ, severe claustrophobia, big metal implants, body size incompatible with MR bore).
• •Contraindications to administration of gadolinium-based contrast agent, including: prior allergic reaction to a gadolinium-based contrast agent, kidney disease (e.g. nephrogenic systemic fibrosis, nephrogenic fibrosing dermopathy) and/or renal failure (GFR \< 30 ml/min/1,73m2).
• •Contra-indications for procedural sedation analgesia with Propofol and Esketamine or Propofol and Remifentanil.
• •Extensive intraductal components in the lesion determined by biopsy.
• •Scar tissue or surgical clips in the HIFU beam path.
• •Inability to lie in prone position.
• •Pregnancy or lactation.
• •Communication barrier with patient.
• •The following groups of patients will be excluded because the risk of adjuvant over- or undertreatment due to performing the Bloom and Richardson (B\&R) grading on the tumor biopsy is considered to high:
• •N0, Her2neu negative, \<35 years, ≤1cm (T1a/b) with B\&R grade 1 or 2 on biopsy.
• •N0 Her2neu negative, ER/PR negative (triple negative), 35-70yr, 1.1-2cm (T1c) with B\&R grade 1 or 2 on biopsy.
• •N0, Her2neu negative, ER/PR positive \> 50%, ductal carcinoma, 60-70yr, 1.1-2cm (T1c), with B\&R grade 3 on biopsy and if the MammaPrint is not reimbursed by health insurance also for grade 1 on biopsy.
• •N0, Her2neu negative, ER/PR positive, ductal carcinoma, 35-60yr, 1.1-2cm (T1c) with B\&R grade 1 on biopsy.
• •N0, Her2neu negative, ER/PR positive, but ≤50%, ductal carcinoma, 60-70yr, 1.1-2cm (T1c) with B\&R grade 1.
• •The following group of patients will be excluded based on the results of the MammaPrint:
• •Only if the MammaPrint is reimbursed by health insurance: N0, Her2neu negative, ER/PR positive, \> 50% ductal carcinoma, 60-70yr, 1.1-2cm (T1c), with B\&R grade 1 and MammaPrint high risk.