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 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT05667532
Eligibility Criteria:
Inclusion Criteria:
1. Female patients 30-75 years of age with dense breasts (ACR BI-RADS categories C and D) who undergo routine yearly mammography at participating MDACC sites
2. Willingness to co-enroll or currently enrolled in PA17-0584
3. Willingness to participate in the study and ability to provide informed consent
Exclusion Criteria:
1. Self-reported new breast symptoms since last mammogram including nipple discharge, palpable mass, skin dimpling, or focal pain.
2. Current or recent (within the prior 6 months) history of pregnancy or breast feeding
3. Personal history of breast cancer (DCIS or invasive breast cancer)
4. Treatment of any other type of cancer within the past 5 years excluding in-situ cervical and non-melanoma skin cancer
5. Breast biopsy within 6 months
6. Breast surgery within 12 months
7. Breast MRI, MBI, or CEM performed within 24 months
8. Known allergy to iodine-containing contrast agents
9. History of anaphylactic reaction to any substance that required hospitalization or IV placement in a patient with no known prior uneventful exposure to iodine-based IV contrast
10. Renal insufficiency (as defined by UTMDACC policy 3.30- attachment 1 (appendix D)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT05667532
Study Brief:
Protocol Section:
NCT05667532