Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening

This is an interventional screening trial for Breast Cancer focused on measuring Breast Cancer, screening, breast MRI, contrast enhanced spectral mammography Read More

Inclusion Criteria:

Prospective Patient Recruitment

• Women
• Age > or equal to 30 years
• Recommendation for breast biopsy has been made
• Recommendation for biopsy will result from an imaging work-up originating with a screening exam (mammogram, tomosynthesis, ultrasound, or MRI) that was within 3 months of biopsy.

Reader Study 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:

Prospective Patient Recruitment

• Men
• Women with implants
• Participants who have a known allergy to contrast media.
• Participants who have a known severe allergic response to one or more allergens, defined as anaphylaxis
• Participants with poor asthma control using the National Heart, Lung, and Blood Institute guidelines as defined by:

Symptoms > 2 days per week Short-term beta agonist use > 2 days per week Nighttime awakenings > 2 times per month

• Participants with Renal insufficiency or failure, as determined by GFR < 60 mL/min/1.73 m2 , performed for all patients within 24 hours of the imaging exams
• Participants who are pregnant. Pregnant women are excluded from this study due to the radiation dose from the CT scan and its potential teratogenic effects on the fetus.
• Participants who are breastfeeding are excluded because there is an unknown but potential risk for adverse events in nursing infants secondary to contrast administration in the mother.
• Participants with the following underlying medical conditions: multiple myeloma, myasthenia gravis, dysproteinemias, severe cardiac disease, aortic stenosis, primary pulmonary hypertension, cardiac arrythmia, or severe cardiomyopathy. These underlying medical conditions may make the participant more likely to develop a contrast reaction. This is based on the ACR contrast manual version 10.3 and hospital policy.
• Participants with a concurrent active illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, thyroid storm.
• Participants with thyroid carcinoma or thyroid disease for whom systemic radioactive iodine therapy is part of planned diagnostic work-up or treatment within 2 months following the contrast mammogram study.
• Participants with non-MR compatible objects or implants that would make MRI a contraindication.
• Participants who have a pacemaker, pacer wires, implantable defibrillator, or implanted monitoring device.
• Participants with intracranial clips, metal implants or external clips within 10 mm of the head.
• Participants who have had a metal injury to the eye.

Reader Study 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