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
1 other identifier
observational
400
1 country
1
Brief Summary
To compare DBT and FFDM for screening effectiveness in women who present for screening mammography with respect to screening recall rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 24, 2007
CompletedFirst Posted
Study publicly available on registry
September 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedMay 14, 2010
April 1, 2010
2 years
September 24, 2007
May 13, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare the diagnostic performance of FFDM and DBT in detecting and excluding breast cancer in asymptomatic women.
Eligibility Criteria
Women referred for normal screening mammogram
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GE Healthcarelead
Study Sites (1)
GE Healthcare
Princeton, New Jersey, 08844, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Amy Longcore
GE Healthcare
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 24, 2007
First Posted
September 26, 2007
Study Start
June 1, 2007
Primary Completion
June 1, 2009
Study Completion
July 1, 2009
Last Updated
May 14, 2010
Record last verified: 2010-04