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 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT03859492
Eligibility Criteria:
Inclusion Criteria:
* Women aged 35 and had a negative routine mammogram within 6 months.
* Qualifies as intermediate or high-risk (\>15% lifetime risk of breast cancer as defined by IBIS version 8).
Exclusion Criteria:
* Known breast cancer
* Previously had negative MBI or MRI within 12 months of study
* Pregnant or lactating
* Contraindication to intravenous iodinated contrast
* Unable to understand or sign informed consent
* Self-reported signs or symptoms of breast cancer
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
35 Years
Study:
NCT03859492
Study Brief:
Protocol Section:
NCT03859492