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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT02411760
Eligibility Criteria:
Inclusion Criteria:
Women with Breast Imaging-Reporting and Data System (BI-RADS) 4 or 5 Age ≥ 18 years Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
Subjects who have had a needle biopsy of the suspicious area within the last 6 weeks Subjects who have contraindication to contrast enhanced MRI examination.
Contraindications to MRI examinations include:
Medically unstable
* Heart failure
* Unstable angina
* Child bearing
* Lactating Any contraindication per MRI Screening Form (Appendix A attached).
* Implants contraindicated at 3T, pacemakers
* Poorly controlled diabetes
* Body weight greater than 300 pounds
* Claustrophobic Since each patient is receiving a gadolinium based contrast agent intravenously:
* eGFR \< 60 mL/min/1.73m2
* Sickle cell disease
* Hemolytic anemia
Subjects must not be pregnant or nursing due to the potential for gadolinium contrast agents to harm fetuses or nursing infants.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02411760
Study Brief:
Protocol Section:
NCT02411760