NCT04085510

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,647 (actual)
• Sponsor: Wendie Berg · Academic / Other
• Sex: Female
• Age: 30 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Breast Cancer Female
• Breast Cancer
• Breast Neoplasms
• Neoplasms

Interventions

Type	Name	Description
DEVICE	Contrast-enhanced mammogram	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.

Timeline

• Start date: 2019-10-23
• Primary completion: 2027-09-10
• Completion: 2028-12-30
• First posted: 2019-09-11
• Last updated: 2026-03-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study