Comparison of MRI and CEDM to Evaluate Treatment Response Before Surgery

Memorial Sloan Kettering Cancer Center (MSK)

Status

Completed

Conditions

Breast Cancer

Treatments

Diagnostic Test: Contrast Enhanced Mammography (CEDM)

Diagnostic Test: Breast Magnetic Resonance Imaging (MRI)

Study type

Interventional

Funder types

Other

Identifiers

NCT03070340

17-045

Details and patient eligibility

About

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).

Enrollment

125 patients

Sex

Female

Volunteers

No Healthy Volunteers

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