NCT06105749

Biennial CEM in Women With a Personal History of Breast Cancer

Outcome of Biennial Screening Contrast-Enhanced Mammography (CEM) in Women With a Personal History of Breast Cancer (PHBC)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Wendie Berg · Academic / Other
• Sex: Female
• Age: 30 Years – 79 Years
• Healthy volunteers: Accepted

Summary

This is a prospective clinical trial that will examine if biennial contrast-enhanced mammography added to annual 3D mammography (tomosynthesis) substantially improves breast cancer detection with minimal increase in false-positives, in women with a personal history of breast cancer.

Detailed description

The investigators seek to determine if improved breast cancer detection is maintained with biennial contrast-enhanced mammography (CEM) added to annual digital breast tomosynthesis (DBT) with overall fewer false positives than from annual DBT plus CEM. The investigators will offer biennial CEM exams for eligible patients. Enrolled participants will have a baseline CEM exam with their routine DBT exam, and then have another CEM exam 24 months after their baseline CEM exam and then again at 48 months. Participants will continue to have their annual DBT exams during this time as a part of their usual care. Two radiologists (one primary) will evaluate each pair of examinations by sequentially interpreting each of DBT and CEM in opposing order (primary reader DBT then CEM and secondary reader CEM then DBT), initially blinded to the other modality. We expect that with biennial screening, at least a similar number of cancers will be detected with CEM (and possibly more that were occult on the DBT-only screen 12 months prior), with a similar incremental false-positive rate and at least similar (if not improved) overall positive predictive value (PPV1).

Conditions

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

Interventions

Type	Name	Description
DEVICE	contrast-enhanced mammography	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: 2023-11-08
• Primary completion: 2029-12-01
• Completion: 2031-04-01
• First posted: 2023-10-30
• Last updated: 2025-09-11

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study