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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07471750
Eligibility Criteria:
Inclusion Criteria:
* Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol;
* Have the ability to understand and provide written authorization for the use and disclosure of protected health information (PHI) per the Health Insurance Portability and Accountability Act (HIPAA) privacy ruling;
* Be female;
* Be at least 40 years of age;
* Be asymptomatic; and
* Have received a final BI-RADS Assessment Category of 1 or 2 (negative or benign findings) on her routine screening mammogram.
Exclusion Criteria:
* Has a breast implant;
* Is pregnant or believes she may be pregnant;
* Has delivered and expressed the intention to breast-feed or is currently breast-feeding;
* Has significant existing breast trauma with the last one (1) year;
* Has any breast symptoms (e.g., breast lump, pain, nipple discharge);
* Has been diagnosed or treated for breast cancer within the last year; or
* Is an inmate (see US Code of Federal Regulations 45 CFR 46.306).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT07471750
Study Brief:
Protocol Section:
NCT07471750