Breast Cancer
Conditions
Keywords
mastectomy, breast MRI, contrast enhanced mammography, CEDM, 17-045
Brief summary
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).
Interventions
DIAGNOSTIC_TESTBreast Magnetic Resonance Imaging (MRI)
All women who are scheduled for a post-NAT breast MRI and mammogram will be asked to enroll in the study. The addition of contrast to the FFDM (CEDM) would be the only intervention.
DIAGNOSTIC_TESTContrast Enhanced Mammography (CEDM)
All women who are scheduled for a post-NAT breast MRI and mammogram will be asked to enroll in the study. The addition of contrast to the FFDM (CEDM) would be the only intervention.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare diagnostic accuracy of breast MRI and CEDM | 1 year | To compare the diagnostic accuracy of enhancement on MRI and CEDM in evaluating residual disease extent in women who have completed NAT prior to surgical excision |
Countries
United States
Outcome results
None listed