Tomosynthesis vs. Contrast-Enhanced Mammography in Women With Personal History of Breast Cancer in Western Pennsylvania

Study Overview
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Brief Summary
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This is a prospective clinical trial that will examine if contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false-positives, in women with a personal history of breast cancer.

Detailed Description
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The investigators expect to show in a prospective clinical trial that, in women with a personal history of breast cancer, contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false positives. The investigators expect a substantial increase in node-negative invasive cancers in particular. Because DBT will be interpreted first by one reader, and CEM will be interpreted first, and independently, by a second reader, there will also be an assessment of performance of tomosynthesis alone or CEM alone in this population. Participants will be invited to three rounds of annual screening with CEM. CEM must be performed at the time of or within 6 weeks of routine annual mammogram with tomosynthesis.

Official Title
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Improving Surveillance of Women With Personal History of Breast Cancer Using Contrast-Enhanced Mammography (CEM)

Conditions
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Breast Cancer Female, Breast Cancer, Breast Neoplasms, Neoplasms

Intervention / Treatment
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* Device: Contrast-enhanced mammogram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Asymptomatic women, ages 30-85, with a personal history of breast cancer who have had at least one routine mammogram since treatment. Exclusion Criteria: Women with a history of prior iodinated contrast reaction Women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions) Women who have had bilateral mastectomy Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) < 45 mL/min Pregnancy or lactation Women actively being treated for cancer of any type with chemotherapy Lump or other breast symptoms Abnormality on prior breast imaging that is being followed.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contrast-enhanced mammogram<br>All women will receive both 3D mammography and contrast-enhanced mammography for breast cancer screening; the order of interpretation will vary for each of two radiologists | Device: Contrast-enhanced mammogram<br>* Contrast-enhanced mammography (CEM) is a new FDA-approved exam that is similar to magnetic resonance imaging (MRI) in depicting breast cancers due to increased and leaky blood vessels. Contrast-enhanced mammography is used as an adjunct following mammography and/or ultrasound examinations to localize a known or suspected lesion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer Detection | Number of participants with cancer detected with contrast-enhanced mammography compared to tomosynthesis. Number of patients recalled for additional testing by each imaging test who do not have cancer (false positives). Outcomes will be assessed for both prevalence and incidence screens. | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reader Validation | Reader validation will be performed at study conclusion: number of cancers detected with contrast-enhanced mammography or tomosynthesis. | 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer screening, digital breast tomosynthesis, contrast-enhanced mammogram