Dual-energy Contrast-enhanced (2D and 3D Mammography Versus Contrast-enhanced MRI)- A Pilot Study

Study Overview
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Brief Summary
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This is a pilot study to evaluate 2D contrast-enhanced mammography image and 3D (tomosynthesis) contrast-enhanced images to contrast enhanced MRI in women with greater than 95% probability of breast cancer (BIRADS 5) or confirmed breast cancer (BIRADS 6).This study will then be used to design additional studies.

Official Title
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Evaluation of Contrast-enhanced Mammography and Contrast-enhanced Breast Tomosynthesis: Comparison to Contrast-enhanced Breast MRI- A Pilot Study

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a female of any race and ethnicity. Subject is at least 25 years old Subject has or will have a contrast enhanced breast MRI +/- 31 days of enrollment with no interval treatment or procedure between the two studies Subject has BIRADS 6 or BIRADS 5 cancer or as determined by the radiologist >50% of the biopsied cancer mass must remain following biopsy OR A calcification must be at least 2cm in maximum dimension prior to biopsy or at least 1cm in maximum dimension following biopsy Exclusion Criteria: Subject is unable or unwilling to undergo informed consent Subject has breast implant in the breast to be imaged Subject is pregnant Subject is breast feeding or lactating Subject has a known allergy to gadolinium contrast agents. Subject has a contraindication for MRI. Subject suspected to be at risk to complication from the contrast agents. Subject has a documented renal insufficiency, Subject requires renal dialysis. Subject has had a prior reaction to iodinated contrast. Subject has had a prior episode of anaphylactic reaction to any substance. Subject has taken metformin (Glucophage) within 48 hours of study procedures. Subject has multiple allergies and/or severe asthma regularly treated with medication (prescription and/or over-the-counter).

Ages Eligible for Study
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Minimum Age: 25 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Contrast-enhanced Mammography<br>Subjects will undergo 2D imaging with iodine contrast. | |
| Contrast-enhanced Breast Tomosynthesis<br>Subjects will undergo 3D imaging with iodine contrast. | |
| Contrast-enhanced MRI<br>Each subject imaged with iodine contrast will also be imaged with contrast-enhanced MRI using gadolinium. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A PILOT study to determine Cancer lesion enhancement with CEM and CEBT is non-inferior to that of CEMRI. | This Pilot study is designed to evaluate two x-ray contrast methods with contrast enhanced MRI. Each subject will be imaged with CEM, CEBT and CEMRI. The goals for this will be to: i) Using a Likert scale, Compare the enhancement of breast cancer lesions with CEM, CEBT and CEMRI. ii) Using a Likert scale, Compare the enhancement of benign breast lesions with CEM, CEBT and CEMRI. The results of this study will be used to design studies to measure the sensitivity and specificity of CEM and CEBT. | Fall 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of lesion conspicuity | Using a Likert scale the CEM and the CBT images will be compared with standard pre-contrast mammography and tomosynthesis images to determine lesion conspicuity. | up to one year post study enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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image on multi-modalities, visualize cancer lesions, highly suspicious lesions