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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00535678
• Lead Sponsor: GE Healthcare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-09-24
• Study First Submitted QC: 2007-09-25
• Study First Posted: 2007-09-26
• Primary Completion: 2009-06
• Study Completion: 2009-07
• Status Verified: 2010-04
• Last Update Submitted: 2010-05-13
• Last Update Posted: 2010-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Princeton, New Jersey, United States