Prospective Comparison of Breast MRI vs Contrast Mammography Prior to Surgery in Breast Cancer Patients

Study Overview
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Brief Summary
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In current clinical practice, women with biopsy proven breast cancer can be sent for breast magnetic resonance imaging (MRI) or contrast enhanced mammography (CEM) prior to surgery in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers. This study seeks to compare the global costs (based on actual reimbursement rates) of CEM/breast MRI, downstream imaging testing, and diagnostic procedures in women randomized to breast MRI versus CEM. Secondary goals are to compare patient preferences for CEM vs MRI and clinically relevant outcomes (e.g. conversion from lumpectormy to mastecomy).

Detailed Description
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This is a pilot randomized controlled trial comparing the global costs of two standard of care imaging techniques in patients with a new breast cancer diagnosis and planned breast conservation surgery. Patients enrolled in this study will be randomized to either CEM or breast MRI. The purpose of this study is to compare the global costs (based on actual reimbursement rates) of initial imaging modality (CEM or breast MRI), downstream imaging related to breast cancer evaluation, and diagnostic breast procedures in women randomized to breast MRI versus CEM. Secondary endpoints include assessment of patient's reported satisfaction with the initial imaging technique received (CEM versus MRI), quantifying differences in health-related quality of life (as assessed by the patient reported Euro quality of life 5D questionnaire), rate of conversion from planned lumpectomy to mastectomy, and rate of re-operation for positive margins.

Official Title
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Comparison of Breast MRI Versus Contrast Enhanced Mammography Prior to Surgery in Breast Cancer Patients: a Randomized Controlled Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Breast MRI
* Diagnostic Test: Contrast Enhanced Mammography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18 years or older with newly diagnosed breast cancer and planned breast conservation surgery Clinically indicated referral for breast MRI or contrast mammogram prior to surgery Provision of informed consent Exclusion Criteria: Planned neoadjuvant chemotherapy Patients that are medically unstable Pregnancy Patients with known contraindication to contrast mammography, including: Glomerular filtration rate <30 Known adverse reaction to iodinated contrast material Patients with known contraindication to Breast MRI including: Glomerular filtration rate <30 Known adverse reaction to gadolinium contrast material Non-MRI conditional device or catheter Brain aneurysm clip implanted before 1995 Cochlear implant Ocular foreign body (e.g. metal shavings) Insulin pump Patients unable to read and understand English or Spanish (i.e. an inability to complete study questionnaires)

Ages Eligible for Study
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Minimum Age: 18 Years

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Breast MRI<br>Patients in this arm will be randomized to receive a Breast MRI in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers | Diagnostic Test: Breast MRI<br>* Standard of Care Breast MRI<br>|
| Other: Contrast Enhanced Mammography<br>Patients in this arm will be randomized to receive a Contrast Enhanced Mammograph in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers | Diagnostic Test: Contrast Enhanced Mammography<br>* Standard of Care Contrast Enhanced Mammography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Costs | The Primary outcome is to compare the global costs (based on actual reimbursement rates) of initial imaging modality (CEM or breast MRI), downstream imaging related to breast cancer evaluation, and diagnostic breast procedures in women randomized to breast MRI versus CEM. | Through Study Completion (2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction using modified Likert scale | Patient's reported satisfaction with the initial imaging technique received (CEM versus MRI) will be assessed via Post-Imaging questionnaires designed to gauge patient's opinions about the imaging technique they received. | Through Study Completion (2 years) | 
| Health-Related Quality of Life | quantifying differences in health-related quality of life (as assessed by the patient reported Euro quality of life 5D questionnaire) | Through Study Completion (2 years) | 
| Rate of Conversion | Rate of conversion from planned lumpectomy to mastectomy | Through Study Completion (2 years) | 
| Rate of Re-Operation | rate of re-operation for positive margins | Through Study Completion (2 years) |