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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT04551105
Eligibility Criteria:
Inclusion Criteria:
* B-mode breast ultrasound image
* Female, age 21 or older
* Breast lesion images acquired before a biopsy or surgery - these images were retrospectively collected with histology report.
* Non-biopsied benign lesions with negative follow-up for a minimum of 24 months
* At least two orthogonal views of a lesion
Exclusion Criteria:
* Breast lesion images acquired after biopsy or surgery.
* Any breast surgeries or interventional procedures in the 12 months prior to ultrasound imaging
* Case demonstrating administrative or technical errors
* Multiple lesions in one 2-D ultrasound image
* Breast ultrasound images with Doppler, elastography, or other overlays present
* Case with less than 2-year follow-up and without biopsy confirmation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT04551105
Study Brief:
Protocol Section:
NCT04551105