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

N/AActive Not RecruitingNCT04085510

Wendie Berg1,647 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

1,647

Conditions

Breast Cancer Female Breast Cancer Breast Neoplasms Neoplasms

Interventions

Contrast-enhanced mammogramDEVICE

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.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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) \< 30 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.

Locations (3)

Magee Womancare Passavant Cranberry

Cranberry Township, Pennsylvania, United States

Magee Womancare Monroeville

Monroeville, Pennsylvania, United States

Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 48 months

Secondary Outcomes

Reader Validation

Reader validation will be performed at study conclusion: number of cancers detected with contrast-enhanced mammography or tomosynthesis.

Time frame: 48 months

Data from ClinicalTrials.gov

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