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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT05916703
Eligibility Criteria:
Inclusion Criteria:
* women over 18 years of age
* subject with a breast lesion visible at US, either:
* benign, classified as benign lesions at previous US and unchanged for at least 2 years or with a previous core biopsy done at least 1 year before or BI-RADS 2 or 3, confirmed at histology after SOLUS examination
* or malignant, classified as BI-RADS 4 or 5, confirmed at histology after SOLUS examination
Exclusion Criteria:
* subject is pregnant, breast feeding
* subject is unable or unwilling to give informed consent
* previous core biopsy of the same breast, performed in the last year
* previous breast surgery of the same breast
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05916703
Study Brief:
Protocol Section:
NCT05916703