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

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