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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT05458427
Eligibility Criteria:
Inclusion Criteria:
* Women age 50 or older
Initial schema:
\- Women who are scheduled to undergo a diagnostic work-up following an abnormal screening mammogram with the suspicious finding NOT located in the axillary tail of the breast This initial inclusion criterion will be used until 85 subjects that result in a Breast Imaging Reporting and Data System (BI-RADS) 1 or 2 after clinical diagnostic work-up are recruited and imaged.
Subsequent schema:
\- Women who underwent diagnostic work-up following an abnormal screening mammogram and were assigned a BI-RADS 4 or 5 due to soft tissue lesions (total 120 patients when combined with those from the initial schema), or due to microcalcifications (total 120 patients when combined with those from the initial schema) with the suspicious finding NOT located in the axillary tail of the breast
Each patient can only enroll once in the study.
Exclusion Criteria:
* Women who do not meet the inclusion criteria as described above
* Women with suspected or confirmed pregnancy
* Women who have had bilateral mastectomy
* Women whose suspicious lesion is located in the axillary tail
* Women with prior breast cancer or breast biopsy in the recalled breast in the last 12 months
* Women who are breastfeeding
* Women who are very frail and unable to cooperate
* Women who cannot give informed consent
* Male subjects
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT05458427
Study Brief:
Protocol Section:
NCT05458427