Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer
Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer
The purpose of the study is to evaluate the efficacy of a dedicated Magnetic Resonance guided
 High Intensity Focused Ultrasound (MR-HIFU) unit in ablating breast cancer by comparing MR
 imaging and pathologic specimen after resection.

 Single-center, single-arm, non-randomized trial
The dedicated MR-HIFU unit has been shown to be safe and feasible to ablate breast tissue.

 The planned study should address the possibility to completely ablate breast cancer with the
 dedicated breast MR-HIFU unit. The result of the MR-HIFU therapy should be monitored by
 imaging (contrast enhanced MRI) as well as with histopathological correlation after surgery.

 The patient population would consist of female patients with proven breast cancer scheduled
 for surgical lumpectomy or mastectomy.

 The idea is to evaluate a minimal invasive method to treat breast cancer as a potential
 alternative to surgical resection in the future
Inclusion Criteria:

 -  Informed Consent as documented by signature

 -  World Health Organization (WHO) performance status≤ 2

 -  Body weight ≤ 80 kg

 -  Biopsy proven invasive breast cancer with a size of ≤3.0cm (TNM classification: cT1-2
 N0-2 MX ).

 -  Histological type of tumor: invasive ductal carcinoma (IDC)

 -  Patient is scheduled for surgical resection of tumor at study site

 -  Tumor location within the reach of the HIFU transducers with the patient in prone
 position; distance from skin and pectoral muscle to the tumor ≥ 1.0 cm.

 -  Target breast fits in the cup of the dedicated MR-HIFU breast system

 Exclusion Criteria:

 -  neoadjuvant systemic therapy

 -  prior radiotherapy in target breast

 -  contraindications for MRI

 -  contraindication for application of gadolinium-based contrast agent

 -  contraindication for procedural sedation analgesia

 -  macro-calcifications in or around the targeted tumor

 -  scar tissue or surgical clips in the direct path of the ultrasound beams

 -  Women who are pregnant or breast feeding,

 -  Intention to become pregnant during the course of the study,

 -  Lack of safe contraception, defined as: Female participants of childbearing potential,
 not using and not willing to continue using a medically reliable method of
 contraception for the entire study duration, such as oral, injectable, or implantable
 contraceptives, or intrauterine contraceptive devices, or who are not using any other
 method considered sufficiently reliable by the investigator in individual cases.

 -  Known or suspected non-compliance, drug or alcohol abuse,

 -  Inability to follow the procedures of the study, e.g. due to language problems,
 psychological disorders, dementia, etc. of the participant,

 -  Participation in another study with investigational drug/device within the 30 days
 preceding and during the present study,

 -  Previous enrolment into the current study