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:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT05825768
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed women with biopsy-verified invasive breast cancer
* Age \> 18 year
* Eligible for Breast Conserving Surgery (BCS) based on preoperative ultrasound and mammography
* Cooperative to receive an Magnetic Resonance Imaging (MRI)-examination
Exclusion Criteria:
* Planned mastectomy
* Included patients where the planned BCS changes to mastectomy based on preoperative MRI
* Patients where a preoperative MRI is requiered (patients treated with neoadjuvant therapy and complex cases where a preoperative MRI is needed)
* Previous surgery for pre-malignant or malignant lesions in the breast
* Pregnancy and lactation
* Male breast cancer
* Contraindications for an MRI-examination (pacemaker, severe kidney insufficiency with glomerular filtration rate \< 30 mL/min, and MRI incompatible implants or devices, claustrophobia, disability that prevents an MRI-examination in a prone position, allergy towards Dotarem (intravenous contrast agent for MRI)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05825768
Study Brief:
Protocol Section:
NCT05825768