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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT02156258
Eligibility Criteria:
Inclusion Criteria:
For Screening Subjects
* Be at least 40 years of age, are
* Asymptomatic,
* Scheduled for a routine screening mammogram
For Recall Subjects
* Be at least 18 years of age,
* Received a BIRADS 0 within the last 60 days
* Are recalled for additional imaging
For Diagnostic Subjects
* Be at least 18 years of age,
* Scheduled for a biopsy due to an assessment of Breast Imaging and Reporting Data (BI-RADS®) 4 or 5 after diagnostic work-up of a suspicious screening or clinical finding within the last 60 days.
* Understand requirements and willing to participate in study
Exclusion Criteria:
* Presence of a breast implant.
* Women with only a single breast; for example, post mastectomy patients.
* Is pregnant or believes she may be pregnant.
* A woman who has delivered and who has expressed the intention to breast-feed or is currently breast-feeding.
* A woman who has significant existing breast trauma within the last one year.
* Have self-reported severe non-focal or bilateral breast pain affecting subject's ability to tolerate digital mammography and/or breast tomosynthesis examinations.
* A woman who has had a mammogram performed for the purpose of therapy portal planning within the last year.
* Cannot, for any known reason, undergo follow-up digital mammography and/or breast tomosynthesis examinations (where clinically indicated) at the participating institution.
* Is an inmate (see US Code of Federal Regulations 45CFR46.306).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02156258
Study Brief:
Protocol Section:
NCT02156258