Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT03560102
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03560102
Study Brief:
Protocol Section:
NCT03560102