Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

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 of HIFU table
top., Additional HIFU treatment inclusion criteria based on MRI findings:
• The tumor is located within the reach of the HIFU beam.
• 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.

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 any contrast agent, renal failure (GFR <
30 ml/min/1,73m2).
• Contra-indications for procedural sedation analgesia with Propofol and
Eskatamine or Propofol and Remifentanil.
• Extensive intraductal components in the lesion determined by biopsy, defined
as a ratio of more than 0.5 when dividing the number of ducts or lobules
involved with carcinoma in situ by the number of tissue cores in the biopsy.
• Scar tissue or surgical clips in the HIFU beam path.
• Inability to lie in prone position.
• Pregnancy or lactation.
• Communication barrier with patient.
• 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., • 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is the efficacy of MR-HIFU for ablation of<br /><br>breast tumors assessed by the amount of necrotic tumor tissue, which will be<br /><br>determined by MRI and by histopathologic examination after resection. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoint is safety, assessed by reporting adverse events and by<br /><br>NRS (numeric rating scale) after the MR-HIFU procedure.</p><br>

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