Comparison of MRI and CEDM to Evaluate Treatment Response Before Surgery

Study Overview
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Brief Summary
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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).

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Breast Magnetic Resonance Imaging (MRI)
* Diagnostic Test: Contrast Enhanced Mammography (CEDM)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast MRI and Contrast Enhanced Mammography (CEDM)<br>Breast MRI and CEDM will be performed within 30 days of one another after neoadjuvant therapy | Diagnostic Test: Breast Magnetic Resonance Imaging (MRI)<br>* 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.<br>Diagnostic Test: Contrast Enhanced Mammography (CEDM)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare diagnostic accuracy of breast MRI and CEDM | 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 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mastectomy, breast MRI, contrast enhanced mammography, CEDM, 17-045