Efficacy of MR-HIFU Ablation of Breast Cancer
Efficacy of MR-HIFU Ablation of Breast Cancer
This study evaluates the efficacy of MR-HIFU ablation of breast cancer. Ten patients with
 early-stage breast cancer with a maximum diameter of 3 cm will undergo MR-HIFU ablation,
 followed by MRI and surgical resection to evaluate treatment effect. The main purpose of the
 study is to demonstrate the feasibility of total tumor ablation with MR-HIFU. The secondary
 objective is safety assessment.
Inclusion Criteria:

 -  Women, aged 18 years and older.

 -  Able to give informed consent herself.

 -  World Health Organization (WHO) performance score ≤ 2.

 -  Biopsy proven cT1-2 N0-2 MX invasive breast cancer with a size of ≤ 3.0 cm.

 -  Histological type of tumor: invasive ductal carcinoma (IDC), not otherwise specified
 (NOS) or no special type (NST).

 -  The target breast fits in the cup of the dedicated MR-HIFU breast system.

 -  Patient weight is limited to ≤ 90 kg, because of restrictions to the HIFU table top.

 Additional inclusion criteria based on DCE-MRI findings:

 -  The distance of the tumor, including a 5 mm margin around the tumor, from the skin,
 nipple and pectoral wall is at least 1.0 cm measured on MRI.

 -  The tumor is located within the reach of the HIFU beam produced by the transducers in
 the HIFU breast system.

 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.