Comparison of MRI and CEDM to Evaluate Treatment Response Before Surgery

Comparison of Breast Magnetic Resonance Imaging (MRI) and Contrast Enhanced Mammography (CEDM) to Evaluate Residual Disease Extent After Neoadjuvant Therapy (NAT)

The purpose of this study is to compare the diagnostic accuracy of breast magnetic resonance imaging (MRI) and contrast enhanced digital mammography (CEDM) in assessing the residual disease extent in patients who have completed neoadjuvant therapy (NAT).

Inclusion Criteria:

• Any woman who has completed or is nearing completion of neoadjuvant therapy for breast cancer and is scheduled for a post-NAT breast MRI and mammogram
• Surgery (mastectomy or BCT) planned within 60 days of the MRI

Exclusion Criteria:

• Women who have a contraindication to the intravenous use of iodinated contrast agent (i.e., allergy to iodinated contrast or severely impaired renal function with a creatinine level > 1.3 or eGFR ≥45)
• Known allergic reaction to gadolinium; patient may be eligible if the referring physician determines that the MRI is medically necessary and if the patient is willing to undergo pre-medication for contrast allergy
• Pregnant women
• Male patients
• Presence of non MR compatible metallic objects or metallic objects that, in the opinion of the radiologist, would make MRI a contraindication
• Known or suspected renal impairment. Requirements for GFR prior to MRI as determined by local site standard practice
• Women who have already had their standard of care post-NAT mammogram and/or breast MRI