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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT04854304
Eligibility Criteria:
Inclusion Criteria:
1. African American female
2. Negative DBT examination within eleven months prior to recruitment
3. Heterogeneoulsy and Extremely breast densities
4. Clinically asymptomatic- no palpable masses or focal thickening, etc.
Exclusion Criteria:
1. Patients who are pregnant and lactating
2. Patient who have not had a mammogram (DBT) in the past 11months
3. Patients who are unwilling or unable to provide written informed consent
4. Patients symptomatic for breast disease (e.g. experiencing discharge, lumps, ect.)
5. Recent breast surgery in the past 2 years including breast enhancements (e.g. implants or injections)
6. Patients who are unable to received an MRI with Gadolinium contrast
7. Patients who have not had an MRI of the breast with the past year
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT04854304
Study Brief:
Protocol Section:
NCT04854304