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 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT03482557
Eligibility Criteria:
Inclusion Criteria:
* CESM and MRI exam performed within 3 months of one another.
* CESM and breast MRI exams must be performed as part of imaging work-up based on a screening exam of any type (mammography, tomosynthesis, ultrasound, and MRI)
* CESM studies will include at least four low energy and four recombined images (LCC, LMLO, RCC, RMLO).
* MRI exams will include at least fluid sensitive sequence, multi-phase T1-weighted
Exclusion Criteria:
* Imaging sets with implants.
* Imaging sets in which a biopsy or surgical intervention was performed since the most recent screening exam, prior to acquisition of the study MRI or CESM.
* Imaging sets in which a biopsy was recommended, but biopsy was not performed and 2 year imaging follow-up is not available
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
110 Years
Study:
NCT03482557
Study Brief:
Protocol Section:
NCT03482557