Testing Digital Breast Tomosynthesis vs. Regular Mammogram in Detecting Breast Cancer in Women Having Screening Mammogram

GE Healthcare400 enrolled

Overview

To compare DBT and FFDM for screening effectiveness in women who present for screening mammography with respect to screening recall rate.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women ≥18 years or older for screening mammography * Able and willing to comply with study procedures, and have signed and dated the informed consent form * The subject is surgically sterile or postmenopausal Exclusion Criteria: * Pregnant or trying to become pregnant * Has signs or symptoms of breast cancer * Has been previously included in this study * Has breast implants * Has a history of breast cancer and is in active treatment * Has breasts too large to be adequately positioned for the DBT examination

Locations (1)

GE Healthcare

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

Compare the diagnostic performance of FFDM and DBT in detecting and excluding breast cancer in asymptomatic women.

Data from ClinicalTrials.gov

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