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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT02042456
Eligibility Criteria:
Inclusion Criteria:
* Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;
* Women aged ≥18 years at the time of enrollment;\*
* Women with a previous determination of dense breasts determined by mammogram as heterogeneously dense or extremely dense;
* At moderately increased or high risk (\>15% lifetime risk) for breast cancer based on meeting one or more of the ACS criteria 1:
AND Referred for screening mammography
Exclusion Criteria:
* Have been screened using any breast imaging technology in \<12 months immediately prior to enrollment;
* Exhibit breast cancer symptoms according to assessment by the subject's health care provider within one year prior to enrollment;
* Diagnosed with breast cancer, with or without metastasis, within one year prior to enrollment;
* Are currently pregnant as determined per standard clinical practice at the investigational site;
* Present with contraindications to any imaging examination required in the study protocol;
* Have breast implants; OR
* Are lactating.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02042456
Study Brief:
Protocol Section:
NCT02042456