Screening CEDM in Intermediate and High-Risk Patient Populations

Mayo Clinic461 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

461

Conditions

Breast Cancer

Interventions

Contrast Enhanced Digital MammographyDEVICE

High-resolution, low-energy, full-field digital mammography (FFDM) image and contrast-enhanced image

Eligibility

Sex: FEMALEMin age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Outcomes

Primary Outcomes

Breast Cancer

Number of subjects diagnosed with breast cancer

Time frame: 3 years

Data from ClinicalTrials.gov

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