Contrast Enhanced Spectral Mammography With Digital Breast Tomosynthesis For Patients With Newly Diagnosed Breast Cancer

Study Overview
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Brief Summary
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This pilot clinical trial studies how well contrast enhanced spectral mammography works with digital breast tomosynthesis in imaging patients with newly diagnosed breast cancer. Contrast enhanced spectral mammography uses a special dye that is injected into the veins before mammogram images are taken. Digital breast tomosynthesis uses multiple x-ray pictures to produce a 3-dimensional rendering of the entire breast. Contrast enhanced spectral mammography with digital breast tomosynthesis may highlight areas of concern within the breast in more detail than a standard mammogram and improve the accuracy of tumor size.

Detailed Description
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PRIMARY OBJECTIVES: I. To compare the index lesion size (the largest diameter) from each of the four readings (standard of care 2 dimensional [D], magnetic resonance imaging [MRI], contrast enhanced spectral mammography [CESM], 3D) to gold standard index lesion size from surgical pathology (the largest diameter). II. To document the additional ipsilateral and contralateral breast cancer lesions detected by the MRI, CESM, and 3D readings listed above. OUTLINE: Patients undergo a clinical breast examination and a diagnostic mammogram with or without targeted breast ultrasound to the index cancer as part of their standard of care preoperative work-up. As part of the research study, patients receive contrast agent intravenously (IV) and then undergo a CESM with digital breast tomosynthesis (DBT) over 30 minutes. Patients also receive a contrast agent, gadolinium, IV and undergo bilateral breast contrast enhanced (CE)-MRI over 10 minutes. After completion of study, patients are followed up within 24-96 hours.

Official Title
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Emerging Tools in the Detection of Breast Cancer: Comparison of Contrast Enhanced Spectral Mammography With Digital Breast Tomosynthesis to Conventional Imaging Techniques Including Contrast Enhanced Magnetic Resonance Imaging and 2D Mammography With or Without Targeted Ultrasound

Conditions
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Breast Carcinoma

Intervention / Treatment
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* Other: Contrast Agent
* Procedure: Digital Tomosynthesis Mammography
* Procedure: Dual-Energy Contrast-Enhanced Digital Spectral Mammography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed breast cancer patients Exclusion Criteria: Women with history of surgical, medical, or radiation therapy for breast cancer Women with renal failure or insufficiency Women with iodine contrast allergy Women with gadolinium contrast allergy Women who are pregnant, possibly pregnant, or lactating Women undergoing neoadjuvant chemotherapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (CESM with DBT)<br>Patients undergo a clinical breast examination and a diagnostic mammogram with or without targeted breast ultrasound to the index cancer as part of their standard of care preoperative work-up. As part of the research study, patients receive contrast agent IV and then undergo a CESM with DBT over 30 minutes. Patients also receive a contrast agent, gadolinium, IV and undergo bilateral breast CE-MRI over 10 minutes. | Other: Contrast Agent<br>* Given IV<br>* Other names: Contrast Medium;Procedure: Digital Tomosynthesis Mammography<br>* Undergo CESM with DBT<br>* Other names: Digital Tomosynthesis of the Breast;Procedure: Dual-Energy Contrast-Enhanced Digital Spectral Mammography<br>* Undergo CESM with DBT<br>* Other names: Dual-Energy Contrast-Enhanced Digital Subtraction Mammography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Index lesion size using the largest diameter | Intra-class correlation will be used to assess the agreement of index lesion size from each imaging reading to the gold standard (histopathology at surgery). Bland-Altman plot will be used to illustrate the pattern of difference between each reading and the gold standard. | Baseline |