NCT04764292

Screening Contrast-Enhanced Mammography as an Alternative to MRI

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 601 (actual)
• Sponsor: Wendie Berg · Academic / Other
• Sex: Female
• Age: 30 Years – 75 Years
• Healthy volunteers: Accepted

Summary

There are women for whom a screening breast MRI is clinically recommended, but not feasible either due to patient factors (body habitus, pacemaker or other implant, claustrophobia) or access (cost, other constraints). Contrast-enhanced mammography (CEM) is a potential alternative to MRI for screening that uses updated standard mammography equipment to obtain low- and high-energy images after intravenous injection of iodinated contrast (as used in CT scanning). The investigators seek to validate screening CEM as an alternative to screening MRI.

Detailed description

This is a prospective study designed to evaluate the role of contrast enhanced mammography (CEM) in screening for breast cancer. The overarching goal of the research program is to improve cancer detection on screening, particularly in women with dense breasts. MRI depicts more cancers than other screening methods, including ultrasound. MRI is proven to both improve cancer detection and reduce clinically detected cancers ("interval cancers") after a negative screening mammogram in women with dense breasts. PA Senate Bill 595, signed into law June 30, 2020, requires insurance carriers to provide coverage for supplemental screening with MRI or ultrasound for a variety of indications. Relative to the number of women who may benefit from screening MRI, there is a shortage of equipment/capacity. Further, nearly half of women cannot have an MRI for medical or other reasons, such as claustrophobia, implanted devices, body habitus, or cost (deductible and copay apply even with the new legislation). Contrast-enhanced mammography (CEM) appears to have similar performance to MRI but has not been widely validated, particularly for screening. In order to lay the foundation for improved screening of women with dense breasts, the investigators seek to offer screening CEM as an alternative to MRI for women who meet guidelines for screening MRI but are unable to have MRI.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Contrast-enhanced mammography	supplemental breast cancer screening with contrast-enhanced mammography
DRUG	Iodinated Contrast Media (ICM)	supplemental breast cancer screening with contrast-enhanced mammography

Timeline

• Start date: 2021-02-15
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2021-02-21
• Last updated: 2025-09-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study