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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT03573804
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years.
* Female gender.
* Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ
* Tumor size at least 1 cm in diameter as visualized on mammogram or US.
* A diagnostic breast MRI is considered to be clinically indicated.
* Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.
Exclusion Criteria:
* Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes.
* Severe claustrophobia.
* Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (eGFR \< 30 ml/min/1.73m2).
* History of median sternotomy.
* Pregnancy. Patient attestation that they are not pregnant will be acceptable.
* Patients who have received neoadjuvant chemotherapy.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03573804
Study Brief:
Protocol Section:
NCT03573804