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
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
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
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Compare the diagnostic performance of FFDM and DBT in detecting and excluding breast cancer in asymptomatic women.
Principal Investigator
Amy Longcore
Investigator Role:
Study Director
Investigator Affiliation:
GE Healthcare
Authority:
United States: Food and Drug Administration
Study ID:
GE 190-001
NCT ID:
NCT00535678
Start Date:
June 2007
Completion Date:
July 2009
Related Keywords:
- Breast Cancer
- Mammography
- mammogram
- breast
- Abnormal and normal breast tissue
- Breast Neoplasms
Name | Location |
|---|---|
| GE Healthcare | Princeton, New Jersey 08540 |
