Screening CEDM in Intermediate and High-Risk Patient Populations

Mayo Clinic

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Contrast Enhanced Digital Mammography

Study type: Interventional

Funder types: Other

Identifiers

NCT03859492

18-010602

NCI-2022-11058 (Registry Identifier)

Details and patient eligibility

About

This research study is being done to determine if Contrast Enhanced Digital Mammography (CEDM) can improve breast cancer detection and can be used as an additional screening method to the standard mammographic screening.

Enrollment: 461 patients

Sex: Female

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women aged 35 and had a negative routine mammogram within 6 months.
• Qualifies as intermediate or high-risk (>15% lifetime risk of breast cancer as defined by IBIS version 8).

Exclusion criteria

• Known breast cancer
• Previously had negative MBI or MRI within 12 months of study
• Pregnant or lactating
• Contraindication to intravenous iodinated contrast
• Unable to understand or sign informed consent
• Self-reported signs or symptoms of breast cancer

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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461 participants in 1 patient group

Intermediate or high-risk breast cancer subjects

Experimental group

Description:

Subjects with a negative mammogram who are intermediate or high-risk for breast cancer will get supplemental screening with contrast enhanced digital mammography (CEDM)

Treatment:

Device: Contrast Enhanced Digital Mammography