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 @ 10:38 PM
Ignite Modification Date:
2025-12-24 @ 10:38 PM
NCT ID:
NCT02638935
Eligibility Criteria:
Inclusion Criteria:
* Female
* Age ≥18 years
* Patients with a lesion ≥ 0.5 cm in largest diameter size, initially scored BI-RADS® 3, 4a, 4b or 4c in B-mode ultrasound
* Informed consent about histological examination (core cut biopsy (CCB), vacuum-assisted biopsy (VAB), fine needle aspiration (FNA) or surgery) has already been given in the course of clinical routine
* Signed informed consent of study participation
Exclusion Criteria:
* Pregnant or lactating women
* Women with breast implants on the same side as the lesion
* Women that underwent local radiation or chemotherapy within the last 12 months
* Women with history of breast cancer or breast surgery in the same quadrant
* Lesions in or close to scar tissue (\< 1cm)
* Skin lesions or lesions that have been biopsied previously
* Lesion larger than 4 cm in the longest dimension
* No lesion should be included when more than 50% of the lesion is further down than 4 cm beneath the skin level.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02638935
Study Brief:
Protocol Section:
NCT02638935