Improving Characterization of Calcifications With Contrast-Enhanced Mammography

Study Overview
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Brief Summary
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The purpose of this study protocol is to assess whether contrast-enhanced mammography (CEM) will increase the accuracy of characterization of microcalcifications detected on screening mammography prior to biopsy as either benign, high risk, or malignant.

Official Title
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Improving Characterization of Calcifications With Contrast-Enhanced Mammography

Conditions
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Mammography

Intervention / Treatment
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* Device: Contrast-enhanced mammography
* Procedure: Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with calcifications detected on screening mammogram for which biopsy is recommended following characterization on diagnostic mammography. At least 30 years of age. Able to understand and willing to sign an IRB-approved written informed consent document GFR ≥ 30 mL/min/1.73 m2 Exclusion Criteria: Pregnant Prior history of allergy or hypersensitivity reaction to iodinated contrast History of chronic renal disease (including dialysis, kidney transplant, single kidney, renal cancer, or renal surgery) Patients with known thyroid disorders, pheochromocytoma or sickle cell anemia

Ages Eligible for Study
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Minimum Age: 30 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: Contrast-enhanced mammography (CME)<br>-Patients who meet eligibility criteria and consent to participate in this study will complete a CEM examination prior to or on the day that biopsy is scheduled. CEM must occur no later than 60 days after the diagnostic mammogram. The standard of care biopsy must occur no later than 30 days after CEM. | Device: Contrast-enhanced mammography<br>* Contrast-enhanced mammography was FDA approved in 2012 and is currently being used in both clinical and research settings at breast imaging centers throughout the world<br>* Other names: CME;Procedure: Biopsy<br>* Standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate risk characterization of screen-detected calcifications by CEM | -The proportion of women with abnormal enhancement (yes/no) will be compared to the pathology results from the core needle biopsy (benign versus high risk/malignant) | Up to 30 days after the CEM | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of detection of additional sites of disease in the same or contralateral breast on CEM | This will be defined as presence of abnormal enhancement in the same breast at least 2 cm away from the margin of the calcifications of interest or any presence of abnormal enhancement in the contralateral breast at the time of CEM -The reference standard in this case will also be based on pathology results from core needle biopsy (if additional biopsies are performed) or findings on surgical pathology if the patient elects for mastectomy, with the decision for core needle biopsy and lumpectomy vs mastectomy according to surgeon preference and standard of care. | At the time of the CEM (day 1) | 
| Ability of CEM to determine whether accuracy for cancer detection varies as a function of breast density | -Breast density category is routinely reported in the screening mammography report and accepted categories include predominantly fatty, scattered fibroglandular densities, heterogeneously dense, and extremely dense. | At the time of the CEM (day 1) | 
| Ability of whether CEM accuracy for cancer detection varies as a function of the morphology of calcifications as depicted on screening and diagnostic mammography | -Morphology of calcifications include amorphous, coarse heterogeneous, fine pleomorphic, or fine linear branching and/or based on distribution of the calcifications as either diffuse, regional, grouped, linear, or segmental, according to the descriptors in the imaging reports | At the time of the CEM (day 1) |