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

A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 1. Women Undergoing Screening Mammography

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00535678

Enrollment

400

Registered

2007-09-26

Start date

2007-06-30

Completion date

2009-07-31

Last updated

2010-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Mammography, mammogram, breast, Abnormal and normal breast tissue

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results